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FAQ - Singapore (HSA) Regulations for Medical Device Registration


singapore HSA regulations medical devices registration health sciences authority frequently asked questions FAQ

Here are answers to some of the Frequently Asked Questions (FAQs) about Singapore regulations for Medical Device registration.


What is the regulatory authority responsible for medical device registration in Singapore?


The Health Sciences Authority (HSA) is the regulatory authority responsible for medical device registration in Singapore. HSA is a statutory board under the Ministry of Health (MOH) of Singapore. It is responsible for ensuring the safety, quality and efficacy of healthcare products in Singapore.


What are the steps involved in the registration process of medical device in Singapore as per HSA regulations?

The registration process of medical devices in Singapore is as follows:

  1. Determine the risk classification of your device. Medical devices are classified into four risk classes: Class A, Class B, Class C, and Class D. The risk classification of your device will determine the evaluation route and the documentation requirements for registration.

  2. Choose the evaluation route. There are three evaluation routes for medical device registration in Singapore: Immediate Registration (IRB), Abridged Registration, and Full Registration. The evaluation route that you choose will depend on the risk classification of your device, the availability of clinical data, and the prior approvals received from overseas regulatory agencies.

  3. Prepare the registration dossier. The registration dossier is a collection of documents that demonstrate that your device meets the safety, quality, and efficacy requirements of HSA. The contents of the registration dossier will vary depending on the evaluation route that you choose.

  4. Submit the registration application. The registration application can be submitted online through the HSA Medical Device Information and Communication System (MEDICS). The application fee will vary depending on the risk classification of your device.

  5. Review and approval of the application. HSA will review your application and make a decision on whether to register your device. The review process can take several months.

  6. Issuance of the registration certificate. If your device is registered, you will be issued a registration certificate. You will need to display this certificate on your device and on all marketing materials for your device.

For more information on the registration process of medical devices in Singapore, please refer to the HSA website: https://www.hsa.gov.sg/medical-devices/registration

Or email us at info@artixio.com


Here are some additional tips for registering a medical device in Singapore:

  • Start the registration process early. The registration process can take several months, so it is important to start the process early, especially if you are targeting a specific launch date.

  • Work with a qualified consultant. Artixio can can help you navigate the registration process and ensure that your application is compliant with HSA requirements.

  • Keep HSA updated. If there are any changes to your device or your manufacturing process, you will need to notify HSA.


Are there any specific labeling or packaging requirements for medical devices in Singapore as per HSA regulations?

Yes, there are specific labeling and packaging requirements for medical devices in Singapore as per HSA regulations. These requirements are designed to ensure that medical devices are properly labeled and packaged so that they can be used safely and effectively.

The labeling requirements for medical devices in Singapore are set out in the Guidance on Labelling for Medical Devices (GN-23). The labeling must include the following information:

  • The name and address of the manufacturer, packer, or distributor

  • The trade or brand name of the device

  • The unique device identifier (UDI)

  • The intended use of the device

  • The instructions for use

  • Any warnings or precautions

  • The expiry date (if applicable)

  • The batch or lot number

The packaging requirements for medical devices in Singapore are set out in the Guidance on Packaging for Medical Devices (GN-24). The packaging must be designed to protect the device from damage and to ensure that it is used safely and effectively. The packaging must also include the following information:

  • The name and address of the manufacturer, packer, or distributor

  • The trade or brand name of the device

  • The unique device identifier (UDI)

  • The intended use of the device

  • The instructions for use

  • Any warnings or precautions

  • The expiry date (if applicable)

  • ·The batch or lot number

In addition to the labeling and packaging requirements, medical devices in Singapore must also comply with the following requirements:

  • The device must be manufactured in accordance with Good Manufacturing Practices (GMP)

  • The device must be subjected to appropriate clinical trials

  • The device must be accompanied by a Declaration of Conformity (DoC)

For more information on the labeling and packaging requirements for medical devices in Singapore, please refer to the following HSA guidance documents:


Are clinical trials or testing necessary for registration of medical devices in Singapore? If so, what are the HSA requirements?

Clinical trials or testing are not mandatory for registration of medical devices in Singapore. However, clinical trials or testing may be required depending on the risk classification of the device and the availability of clinical data.


  • For Class A devices, clinical trials or testing are not required. However, the manufacturer must provide a risk management file (RMF) that demonstrates that the device is safe and effective.

  • For Class B devices, clinical trials or testing may be required depending on the intended use of the device. If clinical trials or testing are not required, the manufacturer must provide a RMF and other supporting documentation that demonstrates the safety and effectiveness of the device.

  • For Class C and Class D devices, clinical trials or testing are required. The manufacturer must submit a clinical evaluation report (CER) that summarizes the results of the clinical trials or testing. The CER must demonstrate that the device is safe and effective for its intended use.

The HSA has published a guidance document on the clinical evaluation of medical devices in Singapore. This document provides more information on the clinical trial requirements for different risk classes of devices.


The HSA also has a list of approved clinical trial sites in Singapore. Here is a list of some of the approved clinical trial sites in Singapore for medical devices:


  • **ASTAR Clinical Research Centre (ACRC)

  • National University of Singapore (NUS) Yong Loo Lin School of Medicine

  • Singapore General Hospital (SGH)

  • National Heart Centre Singapore (NHCS)

  • Tan Tock Seng Hospital (TTSH)

  • Changi General Hospital (CGH)

  • KK Women's and Children's Hospital (KKH)

  • National Neuroscience Institute (NNI)

  • Singapore Eye Research Institute (SERI)


To be approved as a clinical trial site, the site must meet certain requirements, such as having qualified personnel and having the necessary facilities. The site must also have a valid Institutional Review Board (IRB) approval.


What are the fees associated with the medical devices registration process in Singapore as per HSA regulations?

The fees associated with the medical devices registration process in Singapore as per HSA regulations are as follows:

  • Application fee: The application fee for medical devices registration in Singapore varies depending on the risk classification of the device.

    • Class A: $530

    • Class B: $530

    • Class C: $530

    • Class D: $530

  • Priority review fee: The priority review fee is available for Class B, Class C, and Class D devices. The priority review fee will expedite the review process by 1-2 months.

    • Class B: $840

    • Class C: $1,680

    • Class D: $3,360

  • Annual retention fee: The annual retention fee is required for all registered medical devices in Singapore. The annual retention fee is based on the risk classification of the device.

    • Class A: $37

    • Class B: $64

    • Class C: $128

    • Class D: $256

The fees are subject to change, so it is always best to check the HSA website for the most up-to-date information.


In addition to the fees, there may be other costs associated with the medical devices registration process in Singapore, such as the cost of preparing the registration dossier and the cost of clinical trials.


Is it necessary to have a local authorized representative in Singapore for Medical Device registration?

Yes, it is necessary to have a local authorized representative (LAR) in Singapore for medical device registration. The LAR is a company or individual that is appointed by the foreign manufacturer to represent them in Singapore. The LAR is responsible for submitting the registration application to the Health Sciences Authority (HSA), and for interacting with HSA on behalf of the manufacturer.


The LAR must be a company or individual that is registered with HSA and that has a valid dealer's license. The LAR must also have a qualified person responsible for regulatory affairs (QPR) who is familiar with the HSA regulations for medical devices.


The LAR has a number of responsibilities, including:

  • Submitting the registration application to HSA

  • Responding to HSA queries

  • Providing HSA with updates on the device

  • Ensuring that the device is compliant with HSA regulations

  • Dealing with any post-market issues

The LAR is an important part of the medical device registration process in Singapore. By appointing a LAR, the foreign manufacturer can ensure that their device is properly registered and that they are compliant with HSA regulations.


Here are some of the benefits of having a local authorized representative in Singapore for medical device registration:

  • The LAR can help you navigate the registration process and ensure that your application is compliant with HSA requirements.

  • The LAR can represent you in dealings with HSA, which can save you time and effort.

  • The LAR can provide you with local market insights and help you to build relationships with key stakeholders in Singapore.

If you are planning to register a medical device in Singapore, it is important to choose a reputable LAR who has experience in the medical device industry. The LAR should be able to provide you with a clear understanding of their services and the fees involved.


Are there any post-registration obligations or reporting requirements for medical devices as per HSA regulations in Singapore?

Yes, there are a number of post-registration obligations or reporting requirements for medical devices as per HSA regulations in Singapore. These obligations and requirements are designed to ensure that medical devices remain safe and effective throughout their life cycle.

Some of the key post-registration obligations and reporting requirements include:

  • Change notification: If you make any changes to your medical device, you must notify HSA within 30 days of the change. This includes changes to the device's design, manufacturing process, or labeling.

  • Adverse event reporting: You must report any adverse events (AEs) associated with your medical device to HSA within 15 days of becoming aware of the AE. An AE is any undesirable or unexpected event that occurs during the use of a medical device, and that could potentially harm the patient.

  • Field safety corrective action (FSCA): If you become aware of a safety issue with your medical device, you must take steps to correct the issue. This may involve issuing a recall of the device, or implementing other corrective actions.

  • Product evaluation: You must periodically evaluate your medical device to ensure that it remains safe and effective. This evaluation should include a review of the device's design, manufacturing process, and clinical data.

In addition to these obligations and requirements, you may also be required to comply with other regulations, such as the Good Manufacturing Practices (GMP) regulations.


Are there any exemptions or expedited processes available for certain types of medical devices as per HSA regulations in Singapore?

Yes, there are a number of exemptions or expedited processes available for certain types of medical devices as per HSA regulations in Singapore. These exemptions and expedited processes are designed to facilitate the registration of medical devices that are considered to be low-risk or that have already been approved by other regulatory authorities.

Some of the key exemptions and expedited processes include:

  • Exemption for Class A devices: Class A devices are considered to be low-risk devices, and they are exempt from the full registration process. These devices can be registered through a simplified registration process.

  • Expedited registration for devices approved by other regulatory authorities: If your device has been approved by another regulatory authority that is considered to be equivalent to HSA, you may be eligible for expedited registration. This means that your device can be registered in Singapore without the need to submit a full registration dossier.

  • Special access routes (SARs): SARs are available for devices that are urgently needed in Singapore, but that have not yet been approved by HSA. SARs allow these devices to be used on patients in Singapore under certain conditions.

In addition to these exemptions and expedited processes, you may also be able to benefit from other regulatory schemes, such as the HSA's Regulatory Approval Pathway (RAP) scheme. The RAP scheme is designed to facilitate the registration of innovative medical devices that have the potential to significantly improve patient care.

By taking advantage of the exemptions and expedited processes available, you can help to speed up the registration of your medical device in Singapore. This can give you a competitive advantage in the Singapore market.


Are there any unique considerations or requirements for software or digital health applications in Singapore as per HSA regulations?

Yes, there are a number of unique considerations or requirements for software or digital health applications in Singapore as per HSA regulations. These considerations and requirements are designed to ensure that software and digital health applications are safe, effective, and secure.

Some of the key considerations and requirements include:

  • Risk classification: Software and digital health applications are classified into four risk classes: Class A, Class B, Class C, and Class D. The risk class of the application will determine the evaluation route and the documentation requirements for registration.

  • Cybersecurity: Software and digital health applications must be designed and developed with cybersecurity in mind. This includes ensuring that the application is protected from unauthorized access, use, disclosure, disruption, modification, or destruction.

  • Data protection: Software and digital health applications must comply with the Personal Data Protection Act (PDPA) of Singapore. This means that the application must be used in a way that protects the privacy of the data that it collects or processes.

  • Clinical evaluation: For Class C and Class D applications, a clinical evaluation report (CER) must be submitted to HSA. The CER must demonstrate that the application is safe and effective for its intended use.

  • Labeling and packaging: Software and digital health applications must be labeled and packaged in a way that is clear, accurate, and informative. The labeling must include information about the intended use of the application, the risks associated with the application, and the instructions for use.


Are there any local standards or additional testing requirements beyond international standards for medical devices in Singapore per HSA regulations?

Yes, there are a number of local standards or additional testing requirements beyond international standards for medical devices in Singapore per HSA regulations. These standards and requirements are designed to ensure that medical devices meet the specific needs of the Singapore market.

Some of the key local standards or additional testing requirements include:

  • Therapeutic Goods Administration (TGA) Standards: Singapore has adopted a number of TGA standards for medical devices. These standards are developed by the Therapeutic Goods Administration (TGA) of Australia.

  • Singapore Standards (SS): Singapore has also developed a number of SS standards for medical devices. These standards are developed by the Singapore Standards Council (SSC).

  • Additional testing: In addition to the requirements of international standards, medical devices may also be required to undergo additional testing in Singapore. This testing may be required to assess the performance of the device in a tropical climate or to assess the safety of the device for use by the Singapore population.


Can I use a foreign clinical study or data for medical devices registration purposes in Singapore per HSA regulations?

Yes, you can use a foreign clinical study or data for medical devices registration purposes in Singapore per HSA regulations. However, there are a number of factors that you need to consider before doing so.

Factors to consider:

  • The risk classification of the device: The risk classification of the device will determine the extent to which you can rely on foreign clinical data. For example, you may be able to rely on foreign clinical data for Class A devices, but you may need to conduct additional clinical trials for Class C or Class D devices.

  • The similarity of the population: The population that was studied in the foreign clinical trial should be similar to the population that will be using the device in Singapore. If the populations are not similar, you may need to conduct additional clinical trials in Singapore.

  • The availability of local data: If there is local clinical data available, you should generally use the local data. This is because the local data will be more relevant to the Singapore market.

How to use foreign clinical study or data:

If you decide to use foreign clinical study or data, you will need to submit a justification to HSA. The justification should include information about the following:

  • The risk classification of the device

  • The similarity of the population

  • The availability of local data

  • The reasons why you believe that the foreign clinical data is relevant to the Singapore market


 

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