Navigating Special Purpose Food Registration in Singapore

Special purpose food plays a vital role in catering to individuals with unique dietary needs. According to the Food Regulations, Section 247 Clause, special purpose food is defined as food named or described as particularly suitable for consumption by persons belonging to a specific class who require a special diet. These foods are composed of modified, prepared, or compounded substances that possess nutritive and assimilative properties, making them suitable for individuals requiring specialized diets.

Examples of special purpose food include:

• Diabetic food
• Food containing added phytosterols, phytosterol esters, phytostanols, or phytostanol esters
• Low sodium food
• Gluten-free food
• Low protein food
• Carbohydrate-modified food
• Low calorie food
• Energy food
• Infant formula food
• Formulated food

Additionally, these products may contain vitamins, minerals, amino acids, and other nutrient supplements to support dietary requirements.

Steps to Import Special Purpose Food into Singapore

If you are planning to import special purpose food into Singapore, here are the essential steps to follow:

1. Classify Your Product
   • Determine if your product falls under the food category or another regulated category.
   • Key considerations:
     • Is the product consumed as part of a daily diet or as a dietary supplement?
     • Does it have defined dosage instructions and usage restrictions?
     • Does it come in conventional food forms such as beverages or powders?

   You can refer to the SFA’s Food Classification Guidelines for more information.

2. Check Registration and Licensing Requirements
   • Processed food typically requires product registration.
   • Certain controlled food items, including meats, seafood, eggs, fresh fruits, and vegetables, may require additional licenses.

   More information on registration requirements can be found on the SFA Food Import and Export page.

3. Verify Product Composition
   • Ensure the product formula only contains permitted colorings, food additives, vitamins, minerals, and amino acids as per Singapore’s Food Regulations.
4. Comply with Labelling Requirements
   • The product must include a Nutrition Information Panel in the format specified under the Twelfth Schedule of the Food Regulations.
   • Labelling should indicate the specific dietary purpose and comply with all regulatory requirements.
5. Substantiate Product Claims
   • Product claims must be truthful and not misleading.
   • Avoid statements implying treatment, cure, or prevention of diseases.
   • The product should not claim to replace a specific diet unless backed by scientific evidence.
6. Register Your Product
   • Submit the registration to import processed food products and appliances  to SFA.
   • Activate a Customs account to facilitate importation. Visit the TradeNet System for Customs account registration.
7. Apply for Import Permits
   • Each consignment of special purpose food requires an import permit for customs clearance. This can be applied through the TradeNet System.
8. Customs Clearance and Distribution
   • Once the cargo permit is approved, the consignment can be cleared for customs and distributed locally.

Common Challenges Faced by Importers

Navigating the regulatory landscape can be overwhelming, especially for companies unfamiliar with Singapore’s stringent food regulations. Common challenges include:

• Uncertainty in product classification
• Compliance with labelling and nutrient content requirements
• Delays in product registration
• Rejections due to insufficient documentation

How The Reg Consultants Can Support You

The regulatory landscape for special purpose food can be complex and challenging to navigate. At The Reg Consultants, we provide comprehensive support to help you evaluate your special purpose food products and ensure compliance with Singapore’s regulations.

Our services include:

• Product classification assessment
• Regulatory gap analysis
• Labelling review
• Registration 
• Import permit application

With our expertise in regulatory affairs, we streamline the registration process and help you bring your special purpose food products to the Singapore market efficiently.

Get in Touch with Us Today

Let us take the complexity out of the regulatory process while you focus on growing your business. Contact The Reg Consultants today for personalized guidance and expert support on registering your special purpose food products.

In recent times, we’ve received numerous inquiries about the possibility of rebranding complementary health and cosmetic products in Singapore, particularly due to geopolitical factors. Many companies are looking to facilitate export to their home countries, and understanding how to rebrand products as “Made in Singapore” can be a strategic advantage. In this article, we’ll explore what constitutes a product as “Made in Singapore,” the  pathway  to achieve this , and the certifications available from Singapore Customs , Singapore Manufacturing Federation, as well as the Singapore International Chamber of Commerce, that can facilitate export.

What is Considered a “Made in Singapore” Product?

A “Made in Singapore” product refers to goods that are substantially manufactured or processed within Singapore, in line with regulatory criteria established by local authorities. To earn this designation, a significant portion of the production costs—including labor and materials—must be incurred locally, ensuring considerable local value addition. Furthermore, products must comply with Singapore’s safety, health, and environmental standards to meet quality expectations.

It’s essential to note that if a product is manufactured outside of Singapore and only undergoes labeling or assembly here, it may be labeled as “Packed in Singapore” or “Secondary assembled by ABC Pte Ltd in Singapore.” However, it cannot be marketed as “Made in Singapore,” as this designation necessitates significant manufacturing or processing within the country.

Importance of Free Sale Certificate (FSC) and Certificate of Origin (COO)

When exporting goods, obtaining a Free Sale Certificate (FSC) and a Certificate of Origin (COO) can significantly streamline the process and enhance market acceptance in your destination country.

• Free Sale Certificate (FSC): Issued by Singapore Customs, the FSC confirms that the products are sold locally in Singapore and are compliant with local regulations. It serves as a testament to the product’s quality and safety, making it easier for foreign authorities to accept the product without extensive scrutiny.
• Certificate of Origin (COO): This document attests to the origin of the goods and is essential for international trade. Many countries require proof of origin to determine applicable tariffs and compliance with trade agreements. There are two types of COOs:
  • Ordinary COO (Non-Preferential): Identifies the origin of the good but does not allow overseas buyers to claim preferential tariff treatment, as it is not issued under any Free Trade Agreement.
  • Preferential COO: Enables your buyer to benefit from lower or no customs duty when exporting under a Free Trade Agreement or Schemes of Preferences.

Steps to Brand Your Complementary Health Products or Cosmetics as “Made in Singapore”

1. Set Up a Manufacturing Facility: Establish a manufacturing facility that adheres to Good Manufacturing Practice (GMP) requirements to produce your product, or partner with a licensed contract manufacturing facility that specializes in complementary health products. Ensure that your facility is registered with relevant authorities to facilitate inspections and audits.
2. Ensure Regulatory Compliance: Comply with the relevant regulatory controls for your type of health product. Prepare comprehensive documentation to establish the quality, safety, and efficacy of your product. This documentation should include:
   • Product specifications
   • Safety data sheets
   • Clinical studies (if applicable)
   • Quality assurance protocols

Seek the appropriate approvals before marketing and distributing it locally. This may involve obtaining licenses to import and distribute if necessary.

3. Obtain Necessary Certifications: Once you receive approval from the regulatory authority, you can apply for a Free Sale Certificate from Singapore Customs or a Certificate of Origin from the Singapore Manufacturing Federation and the Singapore International Chamber of Commerce to facilitate exportation, depending on the domestic procedures of your destination country.
   • Free Sale Certificate: To apply for the FSC, submit your application along with supporting documents that demonstrate your product’s compliance with local regulations. The certificate will detail the product’s description, registration numbers, and the local regulatory authority’s confirmation.
   • Certificate of Origin: To obtain a COO, you will need to provide documentation that supports the origin of your goods. This may include:
     • Invoices
     • Shipping documents
     • Manufacturing process details

COs are issued by the Singapore International Chamber of Commerce and the Singapore Manufacturing Federation. Ensure that you are familiar with the requirements of the importing country to facilitate a smooth export process.

For further information, please refer to the following resources:

• Certificate of Origin
• Singapore Customs FAQs

We hope this information proves useful to you. Be sure to check out our other related blogs that may interest you:

• 3 Facts to Know When Importing Cosmetics into Singapore
• Addressing Regulatory Challenges in the Cosmetics and Personal Care Industry in Singapore
• Navigating Nutraceutical Regulations Within the ASEAN Region
• Key Things to Note When Importing Health Supplements into Singapore

 

Navigating the complex world of regulatory affairs is crucial for pharmaceutical and biotech companies looking to ensure compliance while speeding up pharma market access. In Singapore’s competitive landscape, the demand for customised regulatory management has led to the rise of subscription plans tailored to companies of all sizes, from startups to big pharma. These plans go beyond merely ticking compliance boxes — they offer a strategic approach, enabling businesses to focus on what they do best: innovating and growing.

Startup-Friendly Packages

Startups in the pharmaceutical industry often face the challenging task of navigating complex regulatory requirements. Regulatory subscription plans offer a lifeline by providing startup regulatory support that simplifies this process. These plans are designed to help fledgling companies efficiently manage the landscape, providing individualised guidance that addresses the specific needs of early-stage businesses. By breaking down the process into manageable steps, these subscriptions empower startups to focus on product development, confident that their compliance is in capable hands.

Comprehensive Compliance Solutions

For established pharmaceutical companies, regulatory adherence is non-negotiable. The stakes are high, and the demands are often extensive. Regulatory management subscription plans cater to these needs by offering thorough big pharma compliance solutions that cover every aspect of regulatory affairs. From managing complex product registrations to providing ongoing conformity with local and international regulations, these plans are crafted to help companies maintain their market position. With a structured approach, companies can avoid costly mistakes and delays, ensuring a smoother path to market access.

Regulatory Guidance and Support

A vital advantage of these subscription plans is their tailored regulatory guidance. In an industry where regulations are constantly evolving, having expert advice on hand is invaluable. Recent studies highlight that the global regulatory landscape has dramatically shifted towards greater strategic collaboration, harmonisation, and convergence among national authorities — a trend that will likely continue. These subscriptions address this by providing continuous support to help companies stay updated with the latest changes, allowing them to remain compliant. This ongoing assistance is crucial for startups and established companies as they can quickly adapt to new requirements and avoid potential pitfalls.

Flexibility and Scalability

As pharmaceutical companies grow, their regulatory needs naturally change. Subscription plans for regulatory affairs are designed with this in mind, offering flexibility and scalability to match the company’s growth trajectory. Whether a company is expanding its product lines, entering new markets, or scaling its operations, these plans can be adjusted to fit their changing needs. This adaptability means that companies can continue to rely on their regulatory subscription plans as they evolve without needing costly overhauls or additional services.

Cost-Effective Compliance Strategies

One of the most significant benefits of regulatory management subscription plans is their cost-effectiveness. Compliance can be an expensive and time-consuming process, especially for smaller companies. However, with a subscription-based model, these plans make regulatory affairs services more affordable for businesses of all sizes. This approach helps manage costs more efficiently, offering a sustainable strategy that fits both the company’s budget and long-term goals.

In Singapore’s dynamic pharmaceutical landscape, regulatory management subscription plans have become essential for both startups and established companies. These subscriptions offer valuable benefits that help businesses navigate regulatory challenges with confidence.

Are you ready to simplify your regulatory journey? Consider partnering with The Reg Consultants to explore our customised subscription plans tailored to your needs. Whether you’re a startup or a big pharma company, our expert team is here to support your goals and speed up your market entry.

Reach out to us today to find the perfect solution for your business.

The medical device sector in Singapore has experienced remarkable growth, driven by the nation’s favorable business environment, robust intellectual property protections, and expanding healthcare demands. However, navigating the high standards and stringent regulatory requirements can be challenging. A thorough understanding of the medical device registration process is essential for manufacturers seeking compliance and a smooth market entry.

This comprehensive guide delves into the regulatory framework, device classification system, and specific compliance requirements in Singapore. By breaking down the complexities, we aim to equip you with the knowledge and tools necessary to manage the medical device registration process effectively, ensuring approval and success in Singapore’s competitive healthcare landscape.

Understanding The Regulatory Framework

Central to the regulatory framework is Health Sciences Authority (HSA), the principal authority tasked with overseeing the safety, quality, and efficacy of medical devices available on the market. As the gatekeeper for public health, HSA certifies that all devices meet stringent standards before they can be introduced to healthcare settings. This responsibility encompasses the entire lifecycle of the devices, from initial registration through to post-market surveillance.

Key Responsibilities of HSA

HSA establishes and enforces a robust set of regulations and guidelines for the manufacture, import, sale, and distribution of medical devices. These rules are designed to make sure that all devices meet high safety and performance standards, safeguarding both patients and healthcare providers.

Medical devices are categorised into four classes—A, B, C, and D—based on their risk levels. The regulatory authority issues licences and permits according to these classifications, determining the extent of scrutiny each device must undergo before it can be marketed. This system streamlines the registration process while upholding stringent safety requirements.

When a device is submitted for registration, they conduct a thorough review that includes technical assessments and compliance checks. Approval is only granted when the device meets all relevant standards, ensuring its safety and effectiveness for its intended use.

Once a medical device is on the market, HSA continues to monitor its performance and safety. This includes overseeing vigilance systems, managing adverse event reports, and conducting periodic inspections to ensure ongoing compliance. This ongoing surveillance helps to swiftly address any issues that may arise post-approval.

Functions

HSA develops policies and guidelines that align with international standards, fostering regulatory harmonisation and facilitating easier market access for the devices. These policies help keep Singapore’s regulatory framework current and effective in a global context.

To support compliance and best practices, they provide guidance and assistance to manufacturers, importers, and healthcare professionals. This is essential for maintaining high industry standards and promoting a culture of regulatory excellence.

HSA also works closely with international regulatory agencies, industry associations, and healthcare institutions. These partnerships are vital for aligning global regulations, sharing valuable information, and addressing emerging challenges in the medical device sector.

Regulatory Requirements for Medical Devices

Understanding the regulatory requirements for medical devices is essential for manufacturers aiming for compliance and successful market entry. The devices are classified by their risk levels, with each class having its own set of regulatory demands. This classification helps outline the necessary level of scrutiny and documentation for registration. In this section, we’ll delve into how the devices are categorised and the criteria used to assess their risk levels.

Classification of Medical Devices in Singapore

• Class A Devices

Class A devices are considered low-risk and typically have minimal impact on patient safety. They are usually non-invasive and do not enter the body. As they pose minimal risk, the regulatory requirements for Class A devices are relatively straightforward. Common examples of Class A devices are:

• • Tongue Depressors: These devices are simple and pose a negligible risk.
  • Bandages: These are considered low-risk and do not involve invasive procedures.
  • Wheelchairs: Designed to aid mobility, wheelchairs are non-invasive and have minimal impact on patient health.

• Class B Devices

Class B devices are classified as low to moderate-risk and generally involve some degree of invasiveness. These devices may be used for procedures that penetrate the skin or mucous membranes but generally pose manageable risks. Examples of Class B devices include:

• • Hypodermic Needles: These needles are used for injections or drawing blood. They penetrate the skin but are equipped with safety features to minimise risks.
  • Prescription Contact Lenses: The lenses come into direct contact with the eyes and require careful handling to prevent infections.
  • Therapy Lasers:  The equipment provides hot and cold therapy for treatment of fibromyalgia.

• Class C Devices

Class C devices are classified as moderate to high-risk due to their invasive nature and the higher potential for risk. These devices are often used in more critical medical situations and require thorough evaluation. Class C devices include the following:

• • Ventilators: Essential for supporting or replacing breathing, ventilators are complex devices with significant health implications.
  • Bone Fixation Plates: The plates are implanted into the body and must meet high safety standards. 

• Class D Devices

Class D devices are considered high-risk and can have serious health consequences if they malfunction or are used improperly. These devices are typically used in life-supporting or life-sustaining situations. Some examples of Class D devices are:

• • Heart Valves: Critical for managing heart function, valves are implanted into the body and must be meticulously regulated.
  • Implantable Defibrillators: These devices, which correct life-threatening cardiac arrhythmias, require stringent regulatory oversight due to their complexity and potential impact on patient health.

Criteria for Classification Based on Risk

The criteria for classifying medical devices based on risk are multifaceted and play a crucial role in determining the appropriate regulatory pathway. One primary factor is the device’s intended use. This involves understanding how the device interacts with the human body and its primary function. Devices used for invasive procedures or critical functions typically fall into higher-risk categories because of their significant impact on health.

Another important factor is the degree of invasiveness, which examines whether the device penetrates the body and the extent of this interaction. Devices that penetrate the skin or enter body cavities face more scrutiny due to the heightened risk involved. The duration of contact between the device and the patient also influences classification; devices with prolonged or repeated contact are subject to stricter evaluation to identify any potential adverse effects.

Additionally, the potential risks associated with device malfunction or incorrect use are assessed. Devices with higher potential risks are placed in higher-risk categories to ensure thorough evaluation. 

Finally, technological characteristics such as the complexity and mechanism of action of the device also affect its regulatory path. Devices with advanced technology or complex mechanisms usually require more detailed scrutiny to confirm their safety and effectiveness.

Read more: What is a Borderline Medical Device in ASEAN Terms and Published List for Your Reference?

Preparing for the Registration Process

Preparing for the medical device registration process in Singapore requires a clear understanding of the documentation requirements and regulatory pathways, which differ based on the device‘s risk classification. Here, we break down the preparation steps and necessary documents for each device class and outline the different routes you can take.

Documentation Requirements for Different Classes

I. Class A (Low Risk):

Class A devices are classified as low-risk and are generally exempt from registration.

For Class A devices, which are considered low-risk, registration is generally exempt. However, they must still meet the Essential Principles for Safety and Performance before being marketed. Manufacturers need to list these devices on the Class A Exemption List in the Medical Device Information Communication System (MEDICS) as part of their dealer’s licence application. While the process for Class A devices is more straightforward, adherence to safety and performance standards remains mandatory to make sure that they are safe to use.

II. Class B, C & D (Higher Risk):

For higher-risk devices classified as Class B, C, or D, a formal registration application must be submitted through MEDICS, along with various supporting documents. The documentation required depends on the evaluation route chosen but will includes the following :

• ASEAN Common Submission Dossier Template (CSDT):  To be aligned according to technical requirements of General Medical Devices or In vitro diagnostic devices.
• Proof of Quality Management System (QMS) Compliance: Class B, C, and D devices must show they meet recognised QMS standards like ISO 13485, US FDA cGMP, or Japan MHLW Ordinance #169.
• Declaration of Conformity to Essential Principles: A declaration of conformity to a set of relevant standards applicable to the device with supporting  pre-clinical and clinical test reports .
• Additional Documents: This will be dependent on the evaluation pathway of the device.

Regulatory Pathways

Navigating the regulatory pathways involves selecting the appropriate route based on your device’s existing approvals and classification. Each route has its own set of requirements and processes, all aimed at ensuring that devices meet the necessary safety and effectiveness standards before they enter the market.

A. General Requirements

Regardless of your chosen route, all applications must be submitted electronically through the HSA’s Medical Device Information Communication System (MEDICS). All documentation must be in English. 

A Singapore-based Licensed Person (individual) or Authorised Representative (company) must manage the registration process. This person or entity is responsible for communicating with the HSA and making sure all regulatory requirements are met. Additionally, a dealer’s licence is needed for importing, distributing, or wholesaling medical devices, highlighting the importance of thorough regulatory compliance throughout the device’s market journey.

B. Evaluation Routes

In Singapore, there are several evaluation routes  based on the device‘s approval status in reference countries  and  risk classification:

1. Immediate Route (IBR) : This is the quickest option for Class B devices.  To qualify, the device must be approved by at least two Reference Countries, such as the United States or the European Union, and must have been marketed for at least three years with no safety issues. This route is ideal for devices that are already well-regulated in major markets, allowing for a faster approval process in Singapore.

2. Expedited Route (ECR/EDR): This route provides a faster registration process for Class C and D devices. To use it, the device must have approval from at least one Reference Country for a labelled use identical to that intended for marketing in Singapore with no safety issues globally and marketed for at least 3 years. This option is advantageous for devices with established international approvals, enabling quicker market entry in Singapore. Implantable devices and hip, knee or shoulder replacement are not applicable for expedited routes.

3. Abridged Route: Available for Class B, C, and D devices with approval from one Reference Country for a labelled use identical to that intended for marketing in Singapore. This route offers a simplified process with potentially fewer documentation requirements. However, specifics can vary based on the device and the standards of the Reference Country.

4. Full Route: The Full Route is the most comprehensive and is required for devices without approvals from any Reference Countries. It demands extensive technical documentation to prove the device’s safety, effectiveness, and compliance with regulatory standards. This route is designed for new or less well-known devices that require a detailed evaluation to enter the Singaporean market.

Read more: Steps to Incorporate New Regulation Changes in Approved Marketing Authorisation (MAs)

Documents Required by Route

When preparing to register your medical devices in Singapore, the documentation requirements vary depending on which evaluation route you choose. Each route has specific documentation needed to ensure that the device meets the country’s regulatory standards. Here’s a detailed breakdown of what you’ll need for each route:

A. Common Documents (All Routes)

1. ASEAN Common Submission Dossier Template (CSDT):

• • Immediate/Expedited Route: For these routes, the CSDT must include a summary of the device’s approvals and marketing history from Reference Countries. This summary shows the device’s proven track record in other regulated markets, supporting its safety and efficacy claims.
  • Abridged Route: The CSDT should reference existing registration documents from the Reference Country. If these references aren’t already in English, they may need to be translated. This route uses existing approvals to simplify the registration process.
  • Full Route: The Full Route requires complete technical documentation. This means providing detailed information that proves the device’s safety, efficacy, and compliance with regulatory standards. This route is the most comprehensive and requires extensive documentation.

2. Device Description:

This document provides detailed information about the device, including its intended use, technical specifications, and the materials used in its production. A complete description helps the regulatory body understand how the device functions and interacts with users.

Summary of Design Verification and Validation

Contains a series of testing reports both pre–clinica and clinical to demonstrate the safety and performance of the device.

3. Risk Analysis:

A thorough risk analysis should pinpoint potential hazards related to the device and describe strategies to manage these risks. This analysis is important for assessing the device’s safety and making sure that appropriate risk management measures are in place.

4. Device Labelling:

Draft labels must be in English and meet HSA regulations. They must also include all essential details, such as device identification, usage instructions, and safety warnings, to ensure that users have clear and accurate information about the device.

5. Instructions for Use (IFU):

Detailed instructions in English are required for the safe and effective use of the device. The IFU should address everything from setup and operation to maintenance and troubleshooting so users can handle the device safely and effectively.

6. Proof of QMS Compliance:

You’ll need a certificate demonstrating that your device complies with a recognised Quality Management System (QMS). Accepted standards include ISO 13485, US FDA cGMP, or Japan MHLW Ordinance #169. This certificate confirms that the device’s manufacturing processes meet international quality standards.

B. Additional Documents 

a. Proof of Approval from Reference Regulatory Agencies: Evidence of approval from both Reference Regulatory Agencies (such as the US FDA and EU notified body ) is required. This shows that the device has been evaluated and approved by multiple reputable regulatory bodies.

b. Marketing History Documentation: Documentation that provides details of the device’s marketing history in these countries, including any adverse events or issues.

c. Declaration of No Safety Issues Globally: This is a formal declaration confirming that no safety issues have been reported globally with the device.

Medical Device Registration Steps

Registering a medical device in Singapore involves several key steps to make sure that the device meets regulatory standards and is safe for use. This process is crucial for getting approval to market the device and requires careful preparation and detailed documentation. Each step is designed to confirm the device’s safety, effectiveness, and compliance with local regulations.

Understanding and following these steps carefully allows you to streamline the approval process and avoid potential delays. Let’s take a closer look at the key stages, starting with pre-submission preparation.

Pre-submission Preparation

Before starting the registration process, it’s essential to prepare thoroughly. This means making sure all necessary documents are complete and accurate. You’ll need to gather key documents, carry out risk assessments, and review clinical data to prove the device’s compliance and safety.

A. Gathering Necessary Documentation

1. Technical Documentation

This includes detailed information about the device’s design, specifications, and manufacturing processes. It’s important to provide documents showing compliance with relevant standards like ISO. Examples of technical documentation include technical drawings, schematics, and assembly procedures, all outlining the device’s construction and operational features.

2. Quality Management System (QMS) Documentation

It’s crucial to show that quality controls are effectively implemented throughout the device’s lifecycle. Quality Management System (QMS) documentation includes procedures and records that highlight these processes. This may include calibration records, inspection reports, batch records, and detailed protocols for testing and validation. These documents help assure regulators that the device is manufactured under strict quality control measures.

3. Clinical Data and Evidence

For higher-risk devices like Class C and D , clinical data is vital to demonstrate safety and efficacy. This involves clinical trial data, investigation reports, and summaries of clinical studies. Essential documents in this category include clinical investigation reports, patient data, and informed consent forms. This evidence supports the claim that the device performs as intended without posing undue risks to patients.

B. Conducting Risk Assessments and Clinical Evaluations

1. Risk Assessments

Identifying potential hazards associated with the device is a fundamental part of the pre-submission process. Risk assessments utilise tools like Failure Mode and Effects Analysis (FMEA) to evaluate potential risks and develop strategies to mitigate them. This involves creating detailed risk management plans and hazard analysis reports to address and control all possible issues.

2. Clinical Evaluations

Clinical evaluations assess the device’s performance and safety based on available clinical data. This step involves verifying that the device functions as intended without posing unnecessary risks. Documentation for this process includes summaries of clinical data, clinical evaluation reports, and post-market surveillance plans to monitor the device’s performance once in use.

Thorough pre-submission preparation confirms that all aspects of the device’s safety, quality, and efficacy are covered. Proper documentation and risk assessment lay the groundwork for a successful registration process, helping to streamline approval and maintain compliance with Singapore’s regulatory standards.

Submission Process

Submitting a medical device registration application is a structured and detailed process to meet the HSA’s requirements. Every step is designed to thoroughly evaluate the device’s safety, efficacy, and regulatory adherence. Below is an overview of the submission process and what you can expect at each stage.

Detailed Steps for Submitting Registration Applications:

1. Initial Application Preparation:

Before submitting your application, gather and carefully prepare all required documentation, such as compiling technical files, clinical data, and quality management system (QMS) records. Ensure that all documents comply with the specific requirements set by the HSA. This step is important as incomplete or non-compliant documentation can lead to delays or rejections.

2. Submission to HSA:

Submit the completed application package through the HSA’s designated electronic submission portal (MEDICS). Your submission must include all necessary forms, certificates, and supporting documents as outlined in the HSA submission guidelines. Double-check that every required document is included to avoid processing delays.

3. Application Review:

Once submitted, HSA conducts an initial review to assess the completeness and compliance of your application. The review includes checking for accuracy and confirming that all documentation adheres to regulatory requirements. This preliminary stage is crucial for identifying any immediate issues that need to be addressed before more detailed evaluations begin.

4. Technical Assessment:

An in-depth technical assessment of the medical device will be conducted, which involves a detailed review of design specifications, manufacturing processes, and QMS documentation. The goal is to confirm that the device meets regulatory standards and functions safely and effectively as intended. This step is critical for verifying the device’s technical soundness.

5. Clinical Evaluation Review:

For higher-risk devices such as Class B, C, and D, clinical trial data and performance reports  are reviewed. This assessment assesses whether the clinical evidence provided supports the device’s safety and efficacy claims. The clinical evaluation is a key component in determining the device’s suitability for market approval.

6. Decision Making:

Based on the outcomes of the technical assessment and clinical evaluation, HSA decides on the application. They may approve it, request further information, or reject it. The decision is communicated to the applicant within a set timeframe, offering clear guidance on any next steps or required actions.

Timeline Expectations and Processing Stages:

• Initial Review: This stage is typically completed within a few weeks to a month after submission, although the exact timeframe can vary depending on the workload and complexity of the application. The focus here is on making sure all initial requirements are met.
• Technical Assessment: Assessments at this stage can take several months, particularly for complex devices that require detailed scrutiny of technical documentation and manufacturing processes. The depth of this assessment ensures that all technical aspects are carefully evaluated.
• Clinical Evaluation: If clinical data is needed, it will add additional time as the HSA reviews the safety and effectiveness based on clinical trials. The duration varies depending on the complexity and volume of data submitted.
• Decision Making: While HSA aims to provide a decision within a specific timeframe after completing the review stages, actual processing times can vary based on the specifics of the application and any additional requests for information.
• Post-Submission Follow-up: After submission, be prepared to respond promptly to any requests for additional information or clarifications (RFIs) from the HSA. Timely responses can help avoid delays and keep the approval process on track.

Read more: How to review and plan for the next regulatory cycle of activities

Post-Submission Activities

Once you’ve submitted your application, the next step is to manage communications and address any issues that may arise during the review process. How you handle these post-submission activities is key to keeping things on track and achieving a positive result. Here’s how to navigate this phase:

You might want to check out our subscription plan which might support your post-licensing activities: https://theregconsultants.com/product/basic-regulatory-subscription-plan/ 

Handling Queries from HSA

Keep a close eye on all communications from the HSA regarding your application. This includes checking your email regularly and monitoring the HSA’s electronic submission portal for any updates or requests. Quickly noting and responding to any queries or requests for additional information is essential to keep the review process moving smoothly.

When responding to queries, make sure your answers are both prompt and accurate. Address each query thoroughly and provide all requested information or documentation. Clear and organised communication is essential to avoid unnecessary delays and keep the review process on track.

Addressing Deficiencies and Follow-up Actions

If HSA identifies deficiencies during the review process, they will issue input requests. Carefully review these input request  to pinpoint the specific concerns or deficiencies. Address each issue by providing additional data, updating documentation, or making corrections as requested. Each deficiency must be accurately handled to ensure compliance and facilitate a smoother review process.

Stay actively engaged throughout this follow-up phase. Collaboration is essential for resolving any outstanding issues or concerns. Maintain open lines of communication with HSA representatives, provide timely updates on corrective actions, and seek clarification if you’re unsure about any aspect of their requests. This helps build a constructive dialogue and makes certain that all concerns are fully addressed.

Keep detailed records of all communications and actions related to any queries and deficiencies. This documentation is useful for tracking your application’s progress and for future follow-ups or audits. Accurate record-keeping also helps maintain a clear and transparent process.

Before finalising any responses or submissions, verify that all requested information and documentation have been included and correctly addressed. Ensure that all corrections are complete and that any additional data is relevant and precise. Confirm with the HSA that they have all the necessary information to proceed with the review.

Frequently Asked Questions

Steering through the registration process can be challenging, and it’s normal to have questions along the way. To help you better understand the key aspects of registration and address any concerns you might have, we’ve compiled answers to some of the most frequently asked questions.

1. What are the key differences between Class A, B, C, and D medical devices? 

In Singapore, medical devices are classified into four risk categories:

• Class A: Low-risk, non-invasive items like tongue depressors or bandages.
• Class B: Moderate-risk devices such as digital thermometers or blood pressure cuffs.
• Class C: Higher-risk devices, including implantables or blood glucose monitors.
• Class D: Highest-risk devices like pacemakers or artificial heart valves.

As the risk level increases, so do the registration requirements, with Class D devices undergoing the most rigorous evaluation.

2. How long does the process typically take in Singapore? 

The time it takes for medical device registration can vary widely depending on factors such as the complexity of the device, the completeness of your submission, and HSA’s current workload. Typically, the process can range from several months to more than a year. Initial reviews and technical assessments usually take a few weeks to a few months. If your device requires clinical evaluations, the process may be longer. To avoid delays, it’s important to respond promptly to any queries or requests for additional information.

3. What are the common reasons for registration application rejections? 

Registration applications may be rejected for several reasons, such as incomplete documentation, failure to meet regulatory standards, or insufficient clinical evidence supporting safety and efficacy claims. Common issues include missing technical files, inadequate clinical data, or non-compliance with quality management system requirements. Additionally, misinterpreting regulatory guidelines or not addressing queries and deficiencies can also lead to rejection. To increase your chances of approval, make sure your documentation is thorough and engage proactively with HSA throughout the process.

Registering a medical device in Singapore requires a careful and detailed approach. It’s important to understand the different device classes and ensure your application meets HSA guidelines. Keep communication open with the authority throughout the process, both before and after approval. By proactively addressing potential issues, you can avoid delays and make the process smoother and more efficient.

For expert guidance and support through every stage of your registration journey, consider partnering with a regulatory affairs services provider. At The Reg Consultants, our experienced team will ensure that your medical device meets all HSA regulations and is positioned for a successful market entry. We offer tailored solutions and comprehensive guidance to make the registration process as smooth and efficient as possible.

Get in touch with us today to discover how we can help you achieve your medical device registration goals in Singapore.

Navigating the complexities of therapeutic product licences in Singapore is important for pharmaceutical and medical device businesses to maintain regulatory compliance. When there are changes to a product’s safety, efficacy, quality, or forensic classification changes after registration of the pharmaceutical products, understanding the process and requirements for licence variations becomes crucial. This guide offers an overview of variation types, the submission process, necessary documentation, regulatory requirements, and the importance of post-approval monitoring.

Types of Variations

Post-approval variations to therapeutic product licences in Singapore are classified as either major or minor. Major variations involve significant changes to the approved indication, route of administration, dosing regimen, intended use, or forensic classification, and require a thorough review by the Health Sciences Authority (HSA), potentially including additional clinical data. On the other hand, minor variations entail less significant changes, such as updates to labelling or packaging , change in address of the manufacturer, submission of CEP in replacement of DMF, etc.  While less complex, they still require careful assessment against what was previously approved and submitted  to ensure compliance with regulatory standards.

Variation Submission Process

Submitting a variation application to the HSA follows a systematic process. Begin by determining the type based on the proposed changes. Follow the appropriate checklist and prepare the documentation appropriate to the category of the MIV.  The last step is to apply through HSA’s online portal, PRISM. Make sure that all the necessary information is complete and accurate to avoid delays. HSA will review the submission and may request additional information if needed. Upon review completion, input requests will be issued if there are any questions, if not you will receive an email notification to inform you of the status of the variation. Do note that for minor variation, only one minor variation can be submitted at all times. Certain minor variations don’t require prior approval, but the application must be submitted within six months of the changes. Additionally, the HSA provides a self-guided tool to assist with minor variation applications. ​​For further details, please visit HSA’s website.

Licence Variation Documentation

The documentation required for licence variations depends on the proposed change type. Major variations typically require detailed information, including new clinical data, revised product specifications, and updated risk assessments. Conversely, minor variations generally need less extensive documentation, such as updated labels or packaging inserts. Providing comprehensive and accurate documentation is vital to meet regulatory expectations and facilitate a smooth approval process.

Singapore Regulatory Guidelines

The regulatory guidelines for variation of therapeutic product licences in Singapore are designed to maintain the safety and efficacy of medical products. HSA mandates adherence to specific guidelines regarding the changes that require approval and the documentation for each type. Familiarity with these guidelines helps streamline the submission process and supports successful pharma market access by ensuring that all regulatory requirements are fulfilled, thereby reducing the risk of non-compliance.

Post-Approval Monitoring

Finally, post-approval monitoring is crucial to upholding the safety and efficacy of therapeutic products. Ongoing surveillance and reporting are necessary to track the product’s performance in the market after a variation is approved. This includes monitoring for any adverse effects or issues that may arise and promptly reporting them to the HSA. Effective post-approval monitoring helps verify that the product continues to meet regulatory standards and remains safe for use.

Managing changes to therapeutic product licences in Singapore is key to staying compliant with regulations. Understanding these factors will help you avoid common pitfalls and ensure that your products remain compliant throughout their lifecycle. 

For expert guidance and comprehensive support with therapeutic product licences in Singapore, our team at The Reg Consultants is always ready to help. We are well-versed in licence variations, submission processes, and regulatory compliance. Discover how our pharma regulatory services can ensure your products meet all necessary standards and maintain their market readiness. 

For companies that already have a mature product pipeline which requires maintenance activities, do check our advance subscription plan for more information. 

Visit our website today and let us help you achieve seamless regulatory compliance.

As standards of living and healthcare quality rise, the demand for pharmaceuticals, medical devices, and other medical commodities, collectively called health products, is on the rise. With more products entering the market, it’s vital to have robust regulatory systems in place to ensure timely access to safe and effective therapies. Strengthening the registration framework is essential for maintaining high standards and protecting public health. In this article, we will delve into five strategies shaping Singapore’s approach to health product regulation, from aligning with international best practices to effectively engaging stakeholders.

Regulatory Harmonisation

A key element of a robust regulatory system is its alignment with international best practices. Singapore has been diligently working to harmonise its standards with global regulations, such as those set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and IMDRF (International Medical Device Regulators Forum). This alignment not only bolsters Singapore’s reputation as a trustworthy market but also makes it easier for both local and international companies to access the market. This fosters innovation and attracts investment, strengthening the country’s position as a reliable and forward-thinking regulatory environment.

Capacity Building in Regulation

A strong regulatory environment relies on a skilled workforce. Singapore has made significant investments in capacity-building programmes to boost the knowledge and skills of its regulatory personnel. These initiatives offer specialised training and professional development, keeping regulators up-to-date with the latest advancements and practices. This focus on human capital development is necessary for ensuring that regulatory decisions are informed, timely, and risk-based.

Read more: Navigating Regulatory Changes in Singapore’s Healthcare Industry

Digitalisation and Automation

The adoption of digitalisation and automation has marked a significant step forward in modernising Singapore’s health product regulatory system. Streamlined registration and approval processes have become more efficient and transparent thanks to these initiatives. Digital tools like electronic submission systems and automated tracking for product defects have boosted both speed and accuracy in regulatory work. This modern approach improves operational efficiency, enhances data management, and supports better decision-making, benefiting both regulators and the industry.

Post-Market Surveillance

Post-market surveillance is another critical strategy for strengthening the regulatory framework. It involves monitoring the safety and effectiveness of health products once they are available to consumers. In Singapore, robust mechanisms are in place to keep track of product performance and address any issues quickly. This includes regular inspections, reporting systems for adverse events, and continuous evaluation of products. By keeping a close watch on health products after they hit the market, potential risks are swiftly managed, helping to protect public health and maintain trust in the regulatory system.

Read more: Responsibilities of a Marketing Authorisation Holder (MAH)

Stakeholder Engagement

Stakeholder engagement plays a vital role in strengthening regulatory systems. Working closely with industry stakeholders, healthcare professionals, and the public helps make regulatory policies more informed and effective. Open dialogue and feedback from various groups allow regulatory authorities to better understand the needs and concerns of those affected by their decisions. This collaborative approach improves the development of regulatory strategies and supports the implementation of new regulations, leading to a more effective and responsive regulatory framework.

Read more: Elevate Your Business With A Regulatory Affairs Management Subscription Plan

In conclusion, the strategies we’ve outlined work together to create a robust and flexible regulatory framework that protects public health while encouraging innovation and economic growth.

At The Reg Consultants, we recognise that navigating the regulatory landscape for health products can be complex. We specialise in offering comprehensive regulatory consulting services to simplify the process. Whether it’s identifying gaps in your dossier, conducting detailed regulatory intelligence, or providing pre-market consultations, we’re here to help you tackle compliance challenges and support your success.

Contact us today to find out more about how we can help you achieve regulatory success

Embarking on the journey of pharma market access requires a strategic approach to distribution—a decision that can significantly influence a company’s trajectory. Our previous article highlighted that the most common approach is to partner with a distributor who is well-versed in the territory to handpick products that resonate with their expertise and portfolio.

TRC based on some on-the-ground experience and insights from expert interviews, presents the 5 self-check questions for your consideration:

1. What is the therapeutic focus of your product meant for?

Most companies have multiple product lines in a single therapeutic area or have multiple therapeutic areas with limited product lines or multiple therapeutic areas and multiple product lines.  The best way to delve into the selection of the key product is to conduct a market analysis to check on:

• The occurrence of the disease in the country
• The “gold standard” treatment for that disease
• The prescribing manual of the physicians
• The competitors’ marketing strategy in the country

This will enable you to grasp the “gaps” where your product could potentially gain market access. Based on our experience, pharma companies that conduct their own market research in this area have a higher success rate of gaining more market share when they launch their product.

2. How common is your product?

The motive of this question is to allow you to delve into the pharma market access strategy by examining the marketing platform, consumer and price point where your product would be able to enter. For generic drugs, it is generally about price, especially if your product is commonly prescribed medications for common ailments such as colds, headaches, coughs or long-term chronic health conditions such as hypertension or diabetes.  For innovative products, you must consider the current alternative treatment if available in the market in the case of medical devices. For example, if you have a gel that treats scars or wounds, how competitive are you in terms when compared to aesthetic applications of a one or two-off treatment?

3. What is the best operation model in this country?

When you have a product where you are able to get access to a wide distributor list, you might want to consider leveraging on them while not forgetting to be self-reliant and supportive of them by offering co-joint marketing schemes to build your brand, which is lacking in many of these relationships established.  For products where that are innovative and have many selling points, it might be worthwhile in terms of pharma market access to consider engaging a third party to register the product first while establishing your own presence locally. In this way, you are able to use Singapore as a HQ for the ASEAN market to reach out to the various countries as Singapore has established many foreign companies’ friendly initiatives that will make it easier for you to kick start first.

4. What would be your marketing strategy?

The most common marketing strategies for healthcare products are either through door-to-door visits with clinicians, congress or participation in exhibitions or even through giving out freebies (health supplements or cosmetics) and e-commerce. This will help you to focus on the right audience: The general public or professionals. Note that for healthcare products that involve the general public, control of advertisement is regulated and highly supervised to avoid any misleading presentation of information facts that will harm the well-being of the public.

5. What is the best price?

Price point requires analysis of competitor products or, rather, gold standard treatment. It could also encompass a low price to high volume (Tender) or small volume but high price (Private). While there’s no one-size-fits-all answer for the best price, the focus should be on delivering value and addressing customer needs, which is important for successful pharma market access.

By analyzing the above 5 questions, it will enable you to put forward a plan that will best suit your market entry into Singapore. For any potential research or regulatory support, please feel free to get in touch with us or consider our plans which might cater to your business needs.