Singapore Medical Device Registration: Class C Devices

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Introduction

Singapore’s medical device regulatory framework is considered one of the most transparent and robust systems in the Asia-Pacific region. Managed by the Health Sciences Authority (HSA), the regulatory process aims to ensure the safety, efficacy, and quality of medical devices entering the market. For companies seeking to register Class C devices, the process can be navigated efficiently with a clear understanding of the available evaluation routes, eligibility criteria, and documentation requirements. This article provides a comprehensive guide to registering Class C medical devices in Singapore, based on the latest regulations outlined in HSA’s guidance documents.

Classification and Overview

Class C medical devices include in vitro diagnostic (IVD) products, active therapeutic devices, and implants that have a significant impact on patients’ health. These devices are one level below Class D (the highest-risk devices) in Singapore’s risk classification system. Their regulatory pathway is more rigorous than for Class A or B devices but can still be streamlined under certain conditions.

Evaluation Routes for Class C Devices

There are four main evaluation routes for Class C medical devices in Singapore:

  1. Full Evaluation Route
  2. Abridged Evaluation Route
  3. Expedited Class C Registration (ECR)
  4. Immediate Class C Registration (ICR)

Each route differs based on the device’s prior regulatory history, risk profile, and whether it qualifies for certain expedited pathways.

  1. Full Evaluation Route

This is the default route for devices that have not received prior approval from any of HSA’s recognized reference regulatory agencies. Under this route, the device undergoes a complete review of its safety, performance, and quality data. It is the most comprehensive and time-consuming pathway but is necessary for novel products or those developed in regions without HSA-recognized authorities.

  1. Abridged Evaluation Route

Devices that have already been approved by at least one of HSA’s reference regulatory agencies – such as the US FDA, TGA (Australia), Health Canada, Japan’s MHLW, or EU Notified Bodies – may qualify for this route. The abridged evaluation assumes that a rigorous assessment has already been conducted by the reference authority, and therefore, the HSA can rely on existing data for a quicker review process. However, the labeled use must be identical to that intended for marketing in Singapore.

  1. Expedited Class C Registration (ECR)

The ECR route has two sub-categories – ECR-1 and ECR-2 – each with specific eligibility requirements:

  • ECR-1 requires that the device has:
    • Approval from one reference regulatory agency.
    • Been marketed in that jurisdiction for at least three years.
    • No significant safety issues (e.g., deaths, serious injuries, global recalls) in the last three years.
    • Not been rejected or withdrawn in any jurisdiction due to quality, performance, or safety concerns.
  • ECR-2 requires that the device:
    • Has approvals from at least two reference regulatory agencies.
    • Has not been subject to rejections or withdrawals for the reasons listed above.

Certain Class C implants – specifically hip, knee, and shoulder non-bioactive replacements – are excluded from ECR and must use the full or abridged routes.

  1. Immediate Class C Registration (ICR)

This route is only applicable to standalone medical mobile applications. To qualify, the app must:

  • Be approved by at least one of HSA’s reference agencies.
  • Have no global safety issues in the past three years.
  • Not have been rejected or withdrawn from any jurisdiction for safety, efficacy, or quality issues.

Reference Regulatory Approvals

For a device to qualify for abridged, expedited, or immediate routes, it must have been evaluated and cleared by a reference agency from the founding members of the Global Harmonization Task Force (GHTF), namely:

  • Australia: TGA Device Registration
  • Canada: Health Canada License
  • Japan: Ninsho or Shonin approval
  • US: FDA 510(k), De Novo, or PMA
  • European Union: CE Mark under various applicable Directives or MDR/IVDR Annexes

It is crucial that the approval is independent and not obtained through Mutual Recognition Agreements (MRAs). Also, devices that are considered Class I or II exempt in the reference agency’s jurisdiction are not eligible for abridged or expedited pathways in Singapore.

Submission Process

The submission of Class C medical devices in Singapore is managed through the MEDICS online portal. The process includes several key steps:

  1. Account Setup and Preparation

Before submission, companies must register through CRIS and link their account to MEDICS. All required documents should be compiled in the ASEAN Common Submission Dossier Template (CSDT) format to ensure compliance with HSA’s standards.

  1. Application Submission and Fee Payment

Applicants select the appropriate evaluation route – Full, Abridged, ECR-1, ECR-2, or ICR –based on eligibility criteria. The application is submitted via MEDICS, and an application fee is charged immediately.

  1. Screening

HSA performs a preliminary screening to confirm dossier completeness and correct route selection. If issues are found, the application may be rerouted, potentially incurring additional fees and delays.

  1. Evaluation

Once accepted, evaluation fees are charged and the technical dossier is reviewed. HSA may issue input requests for clarifications or additional data. A stop-clock mechanism pauses the review timeline until a satisfactory response is received.

  1. Decision and Listing

If the device meets all requirements, it will be approved and listed on the Singapore Medical Device Register (SMDR). If not, HSA will provide the reasons for rejection. Applications may be paused if safety issues arise (e.g., Field Safety Corrective Actions) until resolved.

By following these steps and ensuring documentation is complete and accurate, applicants can streamline the registration process and minimize delays.

Timelines for Approval

The target turn-around times (TAT) for the evaluation of Class C devices (not including stop-clock time) are:

  • Immediate Route: Immediate registration (ICR only)
  • Expedited Route: 120 working days
  • Abridged Route: 160 working days
  • Full Route: 220 working days
  • Full (Priority Review): 165 working days

Documentation Requirements

All Class C device submissions must follow the ASEAN Common Submission Dossier Template (CSDT) format. The core components include:

  1. Letter of Authorization
  2. List of Configurations
  3. Proof of Reference Agency Approval (for abridged, ECR, and ICR)
  4. Marketing History Evidence (ECR-1 only)
  5. Declaration of No Safety Issues (ECR and ICR)
  6. Executive Summary
  7. Essential Principles Checklist and Declaration of Conformity
  8. Device Description
  9. Design Verification and Validation Documents, including:
    • Preclinical studies
    • Biocompatibility
    • Software validation
    • Sterilization (if applicable)
    • Shelf-life and performance
  10. Clinical Evidence (if applicable)
  11. Device Labelling
  12. Risk Analysis
  13. Manufacturer’s Information
  14. Quality Management System (QMS) Certification
  15. Manufacturing Process Flow Chart

For standalone software, documentation specific to cybersecurity and software verification is required.

In-Country Testing and Additional Requirements

One of the more business-friendly aspects of the Singapore system is that local testing is not required. Foreign test results are acceptable, reducing the cost and time of market entry.

However, for expedited or abridged routes, proof of country-of-origin approval (e.g., CE mark) is essential. Moreover, certificates like Free Sale Certificates or Export Certificates may need to be submitted, depending on the circumstances.

Conclusion

Registering a Class C medical device in Singapore can be a smooth process if the product has a strong regulatory history in countries with trusted systems. With clear pathways like abridged, expedited, and immediate evaluations, HSA offers flexibility to manufacturers while maintaining rigorous safety and performance standards. Understanding the eligibility criteria for each route, compiling a complete CSDT dossier, and leveraging prior approvals can significantly reduce time to market.

As Singapore continues to grow as a medical device hub in Asia, navigating its regulatory framework with diligence and accuracy will be essential for companies looking to access this dynamic and high-value market.

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.