The next step after performing a regulatory intelligence exercise would be followed by an arrangement for a consultation with the regulatory authority. This is common especially for IND application and NDA application in which there may be concerns regarding the documentation requirements or even addressing any critical CMC, pre-clinical and clinical study related questions. Today TRC shall share based on observation from the past on what’s the Dos and Don’ts during a formal regulatory consultation meeting in tabular format:
Note that this is just based on TRC’s suggestion of best practice and we do not advocate or represent any voices.
|Present your best self by dressing appropriately and finding a quiet place to participate in the meeting. Switch on the camera during video call meeting.||Do not appear as an unkempt look or even join the meeting in a noisy place to create unpleasant “white noise” during the meeting. If you are unable to switch on the camera during the call, remember to inform during the meeting.|
|Ask questions that are within the meeting agenda provided.
|Do not ask questions for the sake of asking questions if they are not necessary.
In a regulatory meeting, there will be different department personnel joining in. But it would be best to limit those who are executing the work and have an influential decision on how to move the application forward to avoid any unnecessary question or awkward silence to have a need to ask question.
|If the explanation is not clear or specific enough even though the time is running out, ask politely whether you could clear out this important issue so as not to leave it hanging.
|Do not keep pressuring the regulators to double confirm the answers that they are providing. A written response would be provided at the end of the meeting. If there is anything that is not clear, you can write back again once the email is received.|
|Be respectful and transparent about the application that you are intending to submit. Give an overview of the application preparation and the objectives of what you intend to achieve within the meeting.||Do not have more than “one” voice interrupting the flow and “ over talking” about the application that you are intending to submit during the meeting to avoid any confusion or misunderstanding which will not provide you with the appropriate response that you are looking for.|
|Follow a systematic approach to start off the meeting which is by being punctual, following the agenda of the meeting strictly and avoid any over discussion so as to not waste any precious time allocated.||Do not trail off the main questions during discussion and allow the regulator to provide the guidance and ask the next question in sequence unless the question that you have in mind is extremely critical or related to the response that you are hearing.|
|At the end of the meeting, it’s good to pre-empt or suggest a follow up “informal” call by a designated representative should there be any concern that is not well understood from the formal responses provided.||Consolidate all the queries that you have in mind after reviewing the responses provided by the regulators and avoid bombarding them with calls from different people. They are not your answering machines.|
If you think that the above article is useful for you , feel free to share it with your peers and we are also looking forward to hearing some of your experience during consultation meeting. If you require assistance to arrange and support any formal meeting with the local authority, get in touch!
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.
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.
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.
Part of our routine activity in regulatory affairs is to stay in touch with the latest updates and happenings with our local authority so that we can interpret the new changes, assess the impact it has on our existing product licenses and implement a strategic plan to incorporate the changes. Today TRC would like to share the key steps in a typical internal regulatory assessment of new regulations changes:
- Understand the regulations thoroughly
Ensure that you obtain the latest draft or correct version of the new regulations and read the context in dept. Compare it with the current regulations and make notes on the differences that could be important for you to bridge the gaps.
When the draft guidelines are issued for consultation, ask all the questions that you have in mind to align your own understanding and to clear any doubts regarding the new changes.
If there are training sessions conducted by the authority prior to the implementation, it will be good to participate so as to refresh your memory and to enhance the understanding and learn about any new concerns during the Q and A session from other participants.
- Perform an internal assessment
Determine the BU (business unit) and product line that will be affected by the new regulations. Obtain the status of the marketing authorization and a brief understanding of the commercial status of the product in the territory involved.
Perform a gap analysis and document the gaps in order to bridge and incorporate the new change. This should be documented as concise and to the critical point as possible. Share the internal assessment document with the appropriate business unit to obtain feedback so that you can align the findings that you have identified during the gap analysis.
- Determine the steps to incorporate the change
Using the internal assessment as a guideline, prioritize changes in terms of criticality, the commercial impact on the product line and the resources available to support the implementation. Draw up a plan to strategize the implementation and align with local stakeholders and business unit on the requirements and timeline.
Monitor the process of implementation and review post implementation for areas of improvement and effectiveness as well as to capture any areas that were missed out during the initial phase of implementation.
Although the above steps are simple , there may be a risk of miscommunication and lack of internal resources when simultaneous of such regulatory changes are implemented, it could be useful to consider an additional experienced local support . If you think that TRC could be of help to you , please get in touch or learn more about how TRC subscription plan can facilitate the process.
As a regulatory service provider aka consultant, each regulatory consultant has their own unique way of execution of regulatory task especially for regulatory submission. However it would not differ too much from what we are going to share with you.
TRC would like to share with potential prospects of how we usually manage regulatory submission. Please refer to the steps below:
- To initiate the regulatory submission flow, TRC would request Client to provide a secured link for us to access the dossier.
- When dossier is downloaded , TRC would first begin to verify that all sections of the CTD is provided and also verify the file size . For file size exceeding the uploading size onto submission platform, a request would be sent to the Client to split the pdf into smaller size and re-send it to us.
- TRC would execute minor formatting such as renaming of modules if not named appropriately as an example. However, TRC do not do any publishing or formatting of CTD to e-CTD.
- A gap analysis exercise is conducted to identify the points to be addressed prior to submission accordance to classification of the product and evaluation pathway. The gap analysis report will be sent to the prospect to work on the gaps for our review. This would usually take about minimum of 3 round and not exceeding 5 rounds.
- Once the gaps are addressed, we would proceed to perform online submission including the application form filling and uploading of documents.
- Once submission is completed, TRC would furnish the entire set of dossier and a copy of the submission form to the prospect for their reference. TRC also perform our due diligence to keep track of the timelines to receive 1st set of screening queries and between stages throughout the evaluation process to ensure that the submission is on track.
- During the evaluation process, TRC lends their support by facilitating and reviewing the responses provided by the prospect to answer to the queries raised by the evaluator. Similarly, TRC would take the initiative to clear any doubts with regards to the query letter raised to support the prospect to provide the required responses. This is to ensure that each round of evaluation process would be well answered and to avoid duplication of questions from both ends.
- Once approval is received via email, TRC will notify the prospect and remind the prospect to take note of the post-licensing condition imposed in the notification email.
We hope that above has been useful for you if you are contemplating to engage us to support your regulatory submission in Singapore. Do reach out or explore TRC’s new and articles to navigate through article that are useful to you.
A regulatory subscription plan is a newly launched product created by TRC to support medical companies in need of regulatory assistance in a new territory where there is no local office established /when there are only requirement to support post-licensing activities / when additional or alternative support will come in handy when getting the right person on board proves to be difficult/ when you want to explore an alternative way of running your regulatory department /when there are certain conflict of interest between parent company and local company in which an independent party will be useful.
The plan allows you to leverage upon a local expertise to perform the required daily regulatory tasks associated with a typical regulatory specialist and head of regulatory operations. pertaining to the routine operational works on an adhoc basis, tie over peak periods, maternity cover for a short period of time relating to specific regulatory initiatives and project management from a ASEAN perspective
We present a simple comparison chart of Regulatory Subscription Plan Vs Traditional Model.
|Comparison parameters||Regulatory Subscription Plan||Traditional Model|
|Working Principle||Flexible model of rendering regulatory expertise who is already experienced in the local market.||Hiring a staff to manage the regulatory work based on requirements.|
|Cost||It is a fixed cost for experienced personnel.
Can be more cost effective as opposed to having a regular staff if company is just planning on performing post licensing activities and ad-hoc new launched activities .
|Can vary depending on the level of expertise from personnel engaged.
Can incur more cost in the long run and cause distress if company decided to downsize or retrench due to economic outlook.
|Manpower||Resource readily available with years of experience.
Dedicated serving regulatory personnel assigned ( no project manager and etc).
|Need time and resources to train before work can be done.
Dedicated employee .
|Resource allocation and commitment||No commitment basis for the plan.
Able to support various functions which can stretch to pre-product launch such as market research, mediation activities and even audit.
|Commitment required for employment even on contractual basis. If not handled properly might have litigation issues.
“Safe mode” to follow
Fixed duties and function for employee – no flexibility to take on other tasks which is out of scope
|Determining factor in choosing the right model||Have no local office and need someone experienced to kick start the whole process of filing to minimize loss in lead time for product launches.
Limited budget with short time frame on deliverables
Have a non-committed alternative support for the regulatory work to cope with the temporary “lull” period while deciding on the next move for the company or even to support the team while there is internal restructuring which initiatives might still be required to go on.
Have a short trial on a possible operation model of the regulatory function which might be useful in the long run to deal with unexpected circumstances .
|Established presence in the territories for years with good working relationship among partners and staff.
“Expandable budget” to establish own team with a rather flexi timeline
A committed team is essential for the smooth operations of the company.
Fail-safe mode model which worked for many years without resulting in any high turn-over, loss in time and resources to retrain for new employment.
If you have analyzed the chart above and think that it might be suitable to learn more or give it a try, consider to chat up with us using “Contact us” form or even head to the “e-shop” to learn more. We look forward to supporting your initiatives and thanks for your time in reading about this. Do share with your peers who might be in need of this and TRC would be pleased to offer a small token of appreciation for any successful sign-up.
This is a rather short article to share about the definition and published list of borderline medical device that might be supportive for your regulatory intelligence exercise.
A borderline medical device might have some features of a medical device which is to diagnose ,treat or prevent a symptoms or diseases and possibly contain agent or even mode of action which achieve its intended function via pharmacological, immunological or metabolic means. A common product would be that of a wart product which is to get rid of warts through cryotherapy. The mode of action of the wart product could put it at risk of being a drug product rather than a medical device if it contains a caustic agent that destroy warts by chemical coagulation of protein . Hence it is useful for us to know the rule defined by the authority in order for us to classify the product appropriately as medical device.
Definition of medical device in accordance to ASEAN Medical Device Directive:
A “medical device” shall mean any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article: (i) intended by the product owner to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: (a) diagnosis, prevention, monitoring, treatment or alleviation of disease; (b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; (c) investigation, replacement, modification, or support of the anatomy or of a physiological process; (d) supporting or sustaining life; (e) control of conception; (f) disinfection of medical devices; and (g) providing information for medical or diagnostic purposes by means of invitro examination of specimens derived from the human body; which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
Definition of borderline medical device as agreed by the ASEAN Medical Device Committee (AMDC):
In accordance to published guidance document by Medical Device Authority of Malaysia,
Borderline medical devices are devices that are difficult to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal protective equipment. These products are called borderline products until their status of medical device or non-medical device .
The list of borderline medical devices is updated yearly based on decision by the ASEAN Medical Device Committee (AMDC).
Useful references for you to check:
- ASEAN Medical Device Directives
- PRELIMINARY LIST OF BORDERLINE/ MD OR NON MD CLASIFICATION OF MEDICAL DEVICE
- List of Harmonized Classification of Devices
- HARMONISED BORDERLINE PRODUCTS IN ASEAN
If your product does is not listed within the list, you can always write in to us to get a confirmatory response regarding the classification with local authority.
Fueled by a consumer base eager to try out new, up-and-coming products from around the world, Singapore’s cosmetics and personal care industry has experienced remarkable growth in recent years. However, this surge has also caused the demand for quality to rise, with more customers expecting better efficacy and product safety. This increases the challenge that companies in the cosmetics and personal care sector face with regulatory compliance. In this article, we’ll talk about the regulatory challenges that companies should pay attention to and the steps that need to be taken to ensure product safety, compliance, and sustainable growth.
1. Product Safety Assessment
The Health Sciences Authority (HSA) has made it mandatory for manufacturers to conduct rigorous safety assessments, such as toxicological evaluations, to identify any potential risks that their products could cause. This is because, all products, whether for medical applications or personal care, must be safe for use and must not cause any adverse reactions that could pose an issue for public health.
2. Ingredient Restrictions
Apart from product safety assessments, HSA has also established strict regulations regarding the use of specific ingredients in cosmetic and personal care products to further ensure safety.
Businesses must review and update their product formulations regularly to remove restricted ingredients or limit their use in order to comply with these regulatory standards. Additionally, they should invest in research and development to identify safer alternatives, and collaborate with suppliers who provide compliant raw materials.
3. Product Labelling and Packaging
All product labels are required to display essential information about the product to provide customers with accurate information about what they are purchasing and for regulatory authorities to trace products in case of issues. They should include the manufacturer’s contact details, product name, a detailed ingredient list, warnings, and clear usage instructions.
To meet these requirements, businesses must work with designers and regulatory experts to craft labels that adhere to the guidelines, as well as conduct regular reviews of packaging and labelling to ensure they remain compliant with changing regulations.
When it comes to complying with product labelling guidelines, there are numerous intricate details that require attention. We recommend working with a regulatory consulting service to ensure that you do not miss out on any key information.
4. Substantiating Claims
Any product claims, such as “anti-ageing” or “skin whitening,” must be substantiated by scientific evidence. HSA closely monitors these claims, and businesses advertising any misleading or unsupported claims can face penalties.
If companies wish to include any of these claims in their product information or advertisement, research findings and data from scientific studies and clinical trials must be provided to validate these claims. Businesses can also work with qualified dermatologists or experts in related fields to conduct independent assessments of product efficacy.
Otherwise, one simple way to ensure compliance is to avoid the mention of these terms.
5. Good Manufacturing Practices (GMP)
Lastly, companies are required to follow a set of good manufacturing practices in order to better guarantee product quality and safety. They include, but are not limited to:
- Maintaining cutting-edge facilities designed to prevent contamination and ensure cleanliness
- Maintaining comprehensive records of manufacturing processes, testing, and quality control procedures
- Proper storage and distribution practices
- Providing adequate training and education to employees.
Regulatory affairs management in Singapore’s cosmetics and personal care industry is difficult to navigate but an important step to go through. By addressing the above-mentioned challenges effectively, companies can not only ensure compliance with local regulations but also enhance their reputation and competitiveness in the market.
The Reg Consultants is a regulatory service provider that offers both local and overseas cosmetics and personal care companies regulatory assistance. Contact us today to find out how we can help you.
Chinese Proprietary Medicines(中成药产品) refers to finished medicinal product, such as a capsule or tablet, and contains one or more active ingredients from any plant, animal or mineral, or any combination of sources. All the active ingredients must be documented for use in traditional Chinese medicine.
Prior to importation and distribution of CPM in Singapore, CPM must undergo a product listing approval process.
A brief outline of the registration requirements, processing timeline and fees are presented below:
Documentary requirements for imported products are listed below:
- Labels of product to be sold including including inner label, outer carton and package insert
- Photograph of the product’s contents.
- Labels of product sold/supplied in country of manufacture including inner label, outer carton and package insert
- Manufacturer’s Licence or certificate
- Good Manufacturing Practice (GMP) certificate if any
- Product registration certificate (if applicable)
- Free sale certificate of equivalent from country of manufacture
- Test results of toxic heavy metals and microbial contamination
- Storage condition/containers
- Quality parameters for CPM products
- Endorsement of product formula (including all active and inactive ingredients) by overseas manufacturer and undertaking by overseas manufacturer that product does not contain any Western drugs or active synthetic substance
- Information on legal classifications of product in countries of sales
- Website undertaking – for products with website stated on label(s)
- TSE undertaking – for products containing materials (including those used for making capsule shells) derived from ruminants (e.g. cattle, buffalo, sheep, goat, deer, antelope)
- Info for Fermented Substance – for products containing fermented substance(s) (e.g. Cordyceps, Red Yeast Rice)
Processing timeline and fees
The listing process takes about 60 working days and there are no fees associated with listing.
Key pointers before registration
- Ensure that the CPM does not contain any substances from the Poison Act and its schedule.
- If the CPM contains substances listed under the Endangered Species (Import & Export) Act, dealers should contact the Wildlife Management Group of the NParks to obtain the necessary Convention on the International Trade in Endangered Species of Wild Fauna and Flora (CITES) import and export permits.
- The labels cannot reference to certain diseases or conditions such as : blindness, cancer, cataract, drug addiction, deafness, diabetes, epilepsy , hypertension, insanity, kidney disease, leprosy, menstrual disorders, paralysis, tuberculosis, sexual function, infertility, impotency , frigidity, conception, and pregnancy.
- Test report:
- The date of analysis stated on the test report must be within 2 years from the date of evaluation on the CPM product listing.
- The product’s batch number must be stated on the test report, and it must be in accordance with the batch numbering system declared in the online application form.
- If the test result is “not detected/ND”, the limit of detection must be stated on the test report
- The test result cannot be stated as “less than legal limit”
- Quality parameters for CPM should include
- Storage condition
- Physical characteristics of the product such as colour, taste, smell, shape, size of capsule, and can be included in the product’s Certificate of Analysis (COA) or as a separate document.
- Physical specifications as per dosage form
- Note that physical samples of the product and testing might be required by the authority upon request. Testing should be conducted based on laboratories with accredited methods.
Feel free to share this with your peers who has plans to import Traditional Chinese medicine in Singapore or contact us if you need local expertise to support your listing process.
Cell, tissue, gene therapy product (CTGTP) are health products intended for use in humans for a therapeutic, preventive, palliative or diagnostic purpose. CTGTP can contain any of the following and achieves its primary intended action by pharmacological, immunological, physiological, metabolic or physical means.
CTGTP products are divided into 2 classes namely:
Class 1 CTGTP product is deemed as lower risk product that
- is the result of only minimal manipulation of human cell or tissue;
- is intended for homologous use;
- is not combined or used with a therapeutic product and medical device
- is assigned by the Authority as a Class 1 CTGT product due to a lower health risk to a user of the product
Examples: Bone grafts for orthopedic indications ,Scleral patch graft for ocular surgery
Class 2 CTGTP is deemed as a higher risk product which includes human cells or tissue that has been subject to more than minimal manipulation; or is intended for a non-homologous use; or is combined with a therapeutic product or a medical device.
Examples: gene modified cells, cells grown on scaffold , culture expanded cells and vectors with therapeutic gene.
Class 1 product registration requirements
Class 1 CTGTP are exempted from product registration. However, prior to supply, there is a need to notify the authority through an online application form. The processing timeline is about 14 working days and it costs $90 per application.
- Application form
- Table of contents
- Cover letter
- Certified true copy of a valid certificate of accreditation (e.g. American Association of Blood Banks [AABB], American Association of Tissue Banks [AATB], Foundation for the Accreditation of Cellular Therapy [FACT], the College of American Pathologists [CAP])
- Evidence demonstrating that the establishment is registered with local regulatory agency (e.g. US FDA establishment registration and listing for HCT/Ps [human cells, tissues, and cellular and tissue-based products], Health Canada Cells, Tissues or Organs registration certificate, UK Human Tissue Authority)
- Product release specifications or Certificate of Analysis
- Package insert
- Product label
- Product shelf-life and container closure (packaging) information
- List of Class 1 CTGTP checklist
Class 2 product registration requirements
Class 2 CTGTP needs to registered with the authority before it can be supplied. The processing timeline will takes about 230-320 working days depending on the evaluation route. It costs about $30,000 per application inclusion of overseas GCP inspection. The requirements are briefly presented below:
There are three application types and two evaluation pathway illustrated below:
- NDA-1 : For the first strength of a product containing a new CTGTP.
- NDA-2 : For the first strength of a product containing: New combination of registered CTGTP in either of the following:
- New dosage form, such as capsules and injectables.
- New presentation, such as single-dose vials, multi-dose vials and pre-filled syringes.
- New formulation, such as preservative-free.
- Registered CTGTP for use by a new route of administration.
- NDA-3 : For subsequent strengths of a product that has been registered or has been submitted as a NDA-1 or NDA-2.
- Full route: Applies to any new product that has not been approved by any comparable overseas regulator at the time of application submission to HSA.
- Abridged route: Applies to any new product that has been approved by at least one of our comparable overseas regulators.
#Comparable overseas regulators: TGA, Health Canada, FDA, EMA and MHRA.
- CMC requirements: Module 3.2.S to Module 3.2.P .Detailed requirements are as per Appendix 8.
- Non-clinical requirements: Comply with ICH CTD Guidelines M4S (Safety) technical guidelines
- Clinical requirement: Comply with ICH CTD Guideline M4E (Efficacy) technical guidelines, in particular the ICH E3 guidance document on Structure and Contents of Clinical Study Reports
- Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
- Chemistry, Manufacturing and Controls requirements for Cell, Tissue or Gene Therapy Product for Clinical Trials and Product Registration
- Guidance on Cell Tissue and Gene Therapy Products Registration in Singapore
- Guideline on Notification Process for Class 1 Cell, Tissue or Gene Therapy Product
We hope this article is useful to provide you a brief insight into how cell gene therapy products are regulated in Singapore. Feel free to share with your peers . If you need help or support to evaluate the readiness of your dossier please feel free to contact us.
Cosmetics are required to be notified before they can be sold in the market unless in the few circumstances below:
- Supplied solely as a sample in connection with any advertising, sponsorship or promotional activity
- Supplied solely for testing or trial use in connection with any research or development of that product
- Manufactured by or in accordance with the specifications of a medical practitioner, and supplied solely by that medical practitioner for the use of patients under his care
Before supplying cosmetic in Singapore, we need to perform the following steps:
- We need to determine whether the cosmetic product meets the definition of Cosmetic in the local context . As shared in my previous article: https://theregconsultants.com/regulatory-classification-of-medical-products/ ,
A “cosmetic product” is defined as any substance or preparation that is intended to be placed in contact with the various external parts of the human body or with the teeth or the mucous membranes of the oral cavity with a view exclusively or mainly to:
- Changing appearance
- Correcting body odours
- Keeping in good condition
Example of products that are not cosmetics: oral supplements for beauty purposes, injections/injectable products, massage and essential oil, aesthetic/beauty devices, lubricants, insect repellents, sanitary pads, hand sanitizers, cream for treatment of acne/eczema/psoriasis, toothbrush, dental floss, detergent, temporary tattoo fake eye lashes, nail stickers and LED light used in dental kit (whitening gel is a cosmetic).
- In terms of product safety, we need to consider the main components such as the composition, labelling , claims , whether the product manufactured meets the specifications set and whether appropriate testing has been performed to ensure that the product is safe and function as it is claimed.
- We need to ensure that the cosmetic products does not contain ingredients that are in the negative list based on ANNEXES OF THE ASEAN COSMETIC DIRECTIVE.
- Labelling of cosmetics should contains the key information below:
- Name of the cosmetic product
- Function of the cosmetic product
- Instructions for use
- Full ingredients listing
- Country of manufacture
- Contents (weight/volume)
- Batch number
- Manufacturing/ expiry date (expiry date is only required for products with less than 30 months durability)
- Name and address in Singapore of company responsible for placing the product in the market
- Special precautions, if any (especially those listed in Annex III, VI, VII in the ASEAN Cosmetic Directive)
- Cosmetic claims should be appropriate assigned based on the key ingredient function, target site of application and physiological effects of cosmetics. Some examples of claims that can be accepted accordance to ASEAN Cosmetic Claims Guide are presented below:
|Hair care product||Eliminates dandruff permanently Restores hair cells
Hair loss can be arrested or reversed Stimulates hair growth
|Skin products||Prevents, reduces or reverses the physiological changes and degeneration conditions brought about by aging
Prevents, heals, treats or stops acne Treatment of cellulite
Reduces/controls swelling/oedema Removes/burns fat
|Oral or dental hygiene products||Treatment or prevention of dental abscess, gumboils, inflammation, mouth ulcers, periodontitis, pyorrhoea, periodontal disease, stomatitis, thrush or any oral diseases or infections
Whitens tetracycline-induced stains
- Quality of the product- In order to ensure that the product manufacturer meets with international requirements, it would be appropriate to ensure that the manufacturing facilities have relevant certification that complies with GMP or ISO standard 22716:2007 ,perform local testing if required to check for heavy metals and microbiological content, as well as for common adulterants.
Examples of appropriate testing on products are provided below:
|Teeth whitening products||To test the concentration of hydrogen peroxide. Hydrogen peroxide, when in high concentrations, is corrosive and may cause irritation to the eyes, mucous membranes and skin. Only products with hydrogen peroxide of concentration up to 0.1% can be allowed for supply to consumers directly.|
|Skin Whitening creams||To test for the presence of adulterants e.g. Hydroquinone, tretinoin and mercury. Hydroquinone and tretinoin are potent ingredients that are not suitable for use in in skincare cosmetic products. The inappropriate use of hydroquinone could result in changes in skin colour and hypersensitivity reactions such as rashes, redness, tingling and burning of skin. Tretinoin could lead to redness and peeling of the skin and should only be used under medical supervision.|
- Cosmetic notification should be performed by appointed companies that are intending to import or sell the cosmetic products in the market. As cosmetic products are not evaluated by the authority, it is important for importers to be responsible for the safety and quality of the product. There are 3 main things that should be maintained on site for the importer namely:
- Product Information File which contains all the quality and safety records of the cosmetics to comply to the relevant standards. It should be kept to update in accordance to what is happening over at the manufacturing end that could have an impact on your product.
- Records of cosmetic supply to the market- It should be maintained for 2 years in accordance to the Guidelines on the Control of Cosmetics. The record should contain the name and notification number of the product, name and address of company supplied, and the batch number, date and quantity of product supplied.
- Monitor and report any product defect / adverse events to the authority and perform a prompt recall for the product. The reporting timeline is 7 days for adverse events that result in death or life threatening and 15 days for adverse events that results in hospitalisation or any persistent or significant disability or incapacity.
To end off the article, we are sharing some useful links for you to kick start the process:
- Guidelines on the Control of Cosmetic Products
- ASEAN Cosmetic Directive
- Overview on how the local authority regulates cosmetic
- HEALTH PRODUCTS (COSMETIC PRODUCTS — ASEAN COSMETIC DIRECTIVE) REGULATIONS 2007
If you need any support to confirm that your cosmetic product is meeting the local requirements, feel free to be in touch or share it with your peers who might need them.