In the world of healthcare, regulatory compliance is the foundation upon which patient safety and industry integrity are built. That is why when it comes to introducing a medical device to the Singaporean market, there are stringent demands of regulatory compliance to ensure utmost safety, reliability and efficacy. 

In this blog, we delve into the medical device registration process in Singapore, ensuring you adhere to the necessary regulations and providing essential insights for a successful registration. 

Understanding the Medical Device Registration Regulatory Framework in Singapore

The Health Sciences Authority (HSA) in Singapore plays a pivotal role in the evaluation and approval of medical devices. Companies must secure a dealer’s license prior to engaging in the manufacturing, import, or distribution of medical devices. It is a prerequisite that all medical devices undergo registration with HSA before they can be legally distributed in Singapore. 

The evaluation route for your medical device depends on several factors, including the risk classification, prior approvals, and the duration of safe marketing history. The risk classification categorises devices as A (low risk), B (low to moderate risk), C (moderate to high risk), and D (high risk). Determining your device’s classification is a crucial first step, and HSA offers a tool to simplify the process.

However, Class A low-risk medical devices are exempt from the product registration requirement. While Class A medical devices are excluded from product registration, it is important to include the Class A Exemption List within your dealer’s license application through the MEDICS platform.

During the evaluation process, HSA will review the information presented in MEDICS and also the CDST that is shared. It is key to be prompt and comprehensive in your responses, as any delay in furnishing the necessary information may result in a longer medical device registration process.

Furthermore, the Priority Review Scheme expedites the registration and market entry process for medical devices, providing a faster route for approval. This scheme is applicable exclusively to Class B, C, and full evaluation route for Class D devices. Take note that Class D devices with a registrable drug in a secondary role are excluded from this scheme. Under the Priority Review Scheme, the turnaround time (TAT) is significantly shorter, with a 25% reduction compared to the TAT associated with the standard full route.

In certain circumstances, the HSA may grant approval for the import and distribution of unregistered medical devices through the utilisation of Special Access Routes. These situations encompass scenarios such as the import of re-export unregistered devices, unregistered devices intended for non-clinical purposes, custom-made medical devices, and various other specific cases.

Tips for a Successful Medical Device Registration

Here are some valuable tips and insights to ensure your journey towards medical device registration in Singapore is not only smooth but also successful.

• Engaging Experts

It is highly advisable to seek assistance from local experts or consultants well-versed in the regulatory landscape of Singapore. Their experience and understanding of the system can help you to navigate the complexities of the medical device registration process with ease, ensuring compliance and efficiency.

At The Reg Consultants, we provide expert guidance and support throughout the entire registration process ensuring compliance with local GN regulations.

• Thorough Documentation

Make sure all required documentation is not only complete but also accurate. Attention to detail is critical as any discrepancies or omissions can lead to delays or even rejection of your registration. 

• Understand Risk Classification

Familiarise yourself with the risk classification system in Singapore. Knowing the category your device falls under is a major factor as it determines the evaluation route and registration requirements. 

• Compliance with Standards

Your medical device must meet the relevant safety and quality standards. This includes having ISO 13485  certification for medical devices, which is often a fundamental requirement for registration.

Simplifying Compliance at The Reg Consultants

Our mission is clear: to simplify compliance and empower your business to thrive in the complex landscape of medical device registration. With our support, you can navigate compliance with confidence. 

Get in touch with us to find out more.

How to set up a Quality Management System for a SME in medical field

It’s time of the year again where perhaps this question of setting up a Quality Management System has come up to your mind. Whether it is due to a new business direction or complying to upcoming regulations, it’s always good to start early. Let’s go through the 5 steps to do this quickly.

1. Understand what is required for the Quality Management System. A Quality Management System is a set of guidelines and operating procedures to ensure that the company meets its objectives to provide quality and efficient product and services. It can means having a masterfile to provide an overview of the company’s activities and a set of working SOPs/ Work Instructions (WIs) that are already in place.
2. Identify the objectives of the Quality Management System. Identify the key processes in your company’s activities that can impact on your product or services. Identify the key personnels as well as their roles and responsibilities in the Quality Management System.
3. Do a simple gap analysis exercise to improve upon what is missing and add on missing documentation.
4. Execute the Quality Management System for one to two months.
5. 5. Perform a internal audit to assess efficacy as well as area of improve or engage a third party internal auditor to provide feedback on the system.

 

Voila. If you are keen to learn more, please contact us !

Steps to get ready for an overseas on-site GMP inspection for pharmaceutical products in Singapore

With the Covid-19 outbreak, many countries have implemented travel restrictions which have delayed inspections and business trips. Although business has slowed down, it’s a good time for us to review and realign our market strategy to the current situation. If you are currently an overseas company having plans to get your manufacturing site to be Pharmaceutical Cooperation Inspection Scheme (PIC/S) certified, Singapore is one of the best choices due to its stable socio-political situation and it has one of the most structured, organized and clear guidelines to get you started. I will take this opportunity to share with you briefly the 5 steps.

1. For manufacturers who have existing Site Master File(SMF) and Quality Management System Documentation (QMS), it is good to start to align them according to PIC/S guideline for the Site Master File and to look into preparing Quality System Dossier (QSD) according to local regulations. A Quality System Dossier comprises of SMF, related QMS Documentation which includes SOPs, records, diagrams, workflows etc of the pharmaceutical manufacturing operations to provide an overview of the manufacturing site and its quality system so as to facilitate assessment of the manufacturer’s audit readiness.
2. Conduct an internal audit to ensure that process workflow , documents and records are maintained as per Standard Operating Procedures and in compliance with Quality Management System set forth by the company.
3. File for a product registration via a local agent or distributor to trigger the GMP inspection. An audit date will only be assigned should the documentation passed the desktop audit by the regulators. Any critical deficiencies will disqualify the manufacturing site from getting audited .
4. Once the manufacturer has passed the desktop audit, a date will be assigned for an on-site audit.
5. During the on-site audit, a list of observations, non-conformities and good practices will be presented during the closing meeting . The manufacturer will need to provide their Corrective and Preventive Actions (CAPA) 30 days from the date of the audit.
6. If the responses provided are satisfactory, GMP certificate will be issued to the manufacturer within 10 working days calculated from the close-out date.

TRC offer the service of writing a QSD dossier for you. If you are keen, please feel free to get in touch.