Singapore Medical Device Registration: An Overview

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Overview of Singapore’s Medical Device Registration Process

The Health Sciences Authority (HSA) of Singapore is responsible for overseeing the registration of medical devices to ensure their safety, efficacy, and quality before they can be marketed and used within the country. The registration process for medical devices follows specific evaluation routes, which are determined based on multiple factors. These factors include the risk classification of the device, whether the device has received prior approvals from overseas reference regulatory agencies, and the duration for which the device has been marketed safely in other jurisdictions. The chosen evaluation route determines the required documentation, associated fees, and turnaround time (TAT) for the registration process.

Evaluation Routes

To streamline the regulatory process, HSA has established different evaluation routes for medical devices. The evaluation route that applies to a particular device depends on its classification and approval history.

Class A Registration

Medical devices that fall under Class A are exempt from product registration requirements. However, companies intending to market Class A devices in Singapore must complete the Class A Exemption List in the MEDICS system as part of their dealer’s license application.

Class B, C, and D Registration

For medical devices classified as Class B, C, or D, the registration requirements vary based on whether the device has been approved by overseas reference regulatory agencies. Several evaluation routes are available, each with its own conditions and requirements.

Full Evaluation

If a medical device has not received approval from any of Singapore’s recognized overseas reference regulatory agencies, it must undergo a full evaluation. This process involves a comprehensive review of the device’s safety, effectiveness, and compliance with regulatory standards.

Abridged Evaluation

Medical devices that have already been approved by at least one overseas reference regulatory agency may qualify for an abridged evaluation. This route allows for a reduced regulatory burden and faster processing time compared to the full evaluation process.

Expedited Class C Registration (ECR-1)

To qualify for the expedited Class C registration under the ECR-1 route, the medical device must meet the following criteria:

  • The device must have received approval from at least one overseas reference regulatory agency.
  • The device must have been marketed for at least three years in the jurisdiction where it received approval.
  • There must be no reported safety issues related to the device anywhere in the world.
  • The device must not have been previously rejected or withdrawn by either HSA or any overseas reference regulatory agency.

Expedited Class D Registration (EDR)

The expedited Class D registration process follows a similar approach, with additional requirements:

  • The device must have received approval from at least two overseas reference regulatory agencies.
  • The device must not have been rejected or withdrawn by HSA or any other regulatory authority.

Immediate Registration (IBR)

For certain Class B devices, immediate registration is available under two different conditions:

  • Condition 1 requires that the device has been approved by at least one overseas regulatory agency, has been marketed safely for at least three years, and has not been subject to any safety issues, rejections, or withdrawals.
  • Condition 2 requires that the device has been approved by at least two overseas reference regulatory agencies and has not been subject to any safety issues, rejections, or withdrawals.

Immediate Registration for Medical Mobile Applications

Standalone medical mobile applications classified as Class B or Class C may qualify for immediate registration if they have been approved by at least one overseas regulatory agency and have no reported global safety issues or prior rejections.

Devices Not Eligible for Expedited Registration

Certain types of medical devices are excluded from expedited registration and must undergo either the full or abridged evaluation routes. These include:

  • Hip, knee, and shoulder joint replacement non-bioactive implants, which fall under Class C.
  • Active implantable medical devices, such as pacemakers and neurostimulators, which fall under Class D.
  • Implantable devices that come into direct contact with the central circulatory system or central nervous system.
  • Hip, knee, and shoulder joint replacement bioactive implants.
  • Devices that contain a registrable drug component in a secondary role.
  • In vitro diagnostic (IVD) assays used for HIV testing (screening and diagnosis) and blood or tissue donor compatibility testing.

Overseas Reference Regulatory Agencies

Singapore recognizes approvals from several overseas reference regulatory agencies. Medical devices that have been approved by these agencies may qualify for abridged, expedited, or immediate registration, provided that the approval is for the same intended use as in the Singapore market. The recognized agencies include:

  • The Therapeutic Goods Administration (TGA) in Australia. The recognized approval in Australia is the Device Registration License.
  • Notified Bodies (NB) in the European Union. EC certificates are required.
  • Health Canada (HC). Like Australia, the recognized approval in Canada is the Device Registration License.
  • The Ministry of Health, Labour, and Welfare (MHLW) in Japan. Recognized approvals include the two types of Pre-market certification – Ninsho from a Japanese registered certification body or a Shonin from the MHLW
  • The United States Food and Drug Administration (US FDA). Recognized approvals include 510 clearance, De Novo approval, and Premarket approval (PMA)

It is important to note that Class B, C, and D medical devices classified as Class I or Class II exempt by these overseas regulatory agencies do not qualify for Singapore’s expedited registration routes based on those approvals.

Priority Review Scheme

The Priority Review Scheme is designed to facilitate faster registration and market entry for Class B, C, and D medical devices that must undergo full evaluation. This scheme offers a reduction of 35 percent in turnaround time compared to the standard full evaluation route. However, Class D devices that contain a registrable drug component in a secondary role are excluded from the Priority Review Scheme.

There are two routes under the Priority Review Scheme. The first route applies to medical devices that fall within five key healthcare areas and address an unmet clinical need. The second route applies to other medical devices that do not meet these specific criteria but still qualify for expedited processing under the scheme.

Route 1

A medical device qualifies for Route 1 if it falls within one of the following five healthcare areas:

  • Cancer
  • Diabetes
  • Ophthalmic diseases
  • Cardiovascular diseases
  • Infectious diseases

Additionally, the device must either be intended for the diagnosis or treatment of a condition that currently has no existing treatment options or represent a breakthrough technology that provides a significant improvement over existing solutions.

Route 2

Devices that do not meet the criteria for Route 1 may still qualify for priority review under Route 2, which allows for an accelerated review process under specific conditions.

Recent Regulatory Updates

New Guideline for Next-Generation Medical Devices

The Health Sciences Authority (HSA) has introduced a new guideline to streamline the approval process for next-generation medical devices. This guideline allows manufacturers to leverage existing data from previously registered devices, reducing redundant testing. It applies to Class B, C, and D devices that share the same product type and validation criteria with their predecessors but are submitted under the FULL route.

Cybersecurity Labelling Scheme for Medical Devices

Singapore has launched a Cybersecurity Labelling Scheme for Medical Devices to enhance data protection in healthcare. The scheme evaluates devices based on four levels of security certification. The voluntary program targets connected medical devices such as neurology equipment, pacemakers, and insulin pumps. The initiative is a response to growing cyber threats in the healthcare industry, emphasizing the importance of securing medical devices against potential breaches.

Revised Change Management Program for SaMD

HSA has updated its Change Management Program (CMP) for Software as a Medical Device (SaMD) to improve regulatory pathways for post-market changes. The updated framework now includes machine learning (ML)-enabled SaMD and introduces a risk-based approach to evaluating changes. This revision allows for more efficient regulatory oversight while maintaining patient safety, with manufacturers encouraged to engage with HSA before submitting updates.

Conclusion

The medical device registration process in Singapore is designed to ensure that all medical devices entering the market meet rigorous safety and efficacy standards. The evaluation route selected for a device impacts the regulatory requirements, processing time, and approval likelihood. By leveraging overseas regulatory approvals and utilizing expedited pathways or the Priority Review Scheme where applicable, companies can optimize their registration strategy for faster market access. Understanding the nuances of Singapore’s regulatory framework is crucial for medical device manufacturers aiming to introduce new products efficiently and in compliance with local regulations.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)

Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.