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January 2, 2026
Approximately 5 minutes
Singapore HSA Full Registration for Class D Medicinal Product Medical Devices
Singapore HSA Full Registration for Class D Medicinal Product Medical Devices
1. Overview and Applicability
Class D medical devices incorporating a medicinal substance as an integral component (where the substance acts on the human body primarily through pharmacological, immunological, or metabolic means) are regulated as medicinal product medical devices. These require full registration under the Health Products Act, with the Singapore Authorized Representative submitting a complete dossier to the Health Sciences Authority (HSA) for thorough evaluation of both device and medicinal aspects. Approval leads to listing on the Singapore Medical Device Register (SMDR) with specific conditions. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-full-registration
2. Key Regulatory Requirements
The application must demonstrate compliance with:
- Essential Principles of Safety and Performance for the device component
- Quality, safety, and efficacy standards for the medicinal substance (aligned with pharmaceutical requirements)
- Overall risk-benefit assessment considering the combined action
HSA evaluates the device part under medical device regulations and the medicinal part under pharmaceutical regulations, ensuring integrated safety and performance. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-full-registration
3. Required Documentation
The comprehensive dossier typically includes:
- Detailed description of the device and medicinal substance, including mechanism of action
- Manufacturing process for both device and medicinal components
- Quality control data for the medicinal substance (stability, purity, potency)
- Risk management file addressing combined risks
- Preclinical and clinical data supporting safety and efficacy of the combination
- Labeling, instructions for use, and patient information
- ISO 13485 certification for the device manufacturer
- Declaration of Conformity
- Free Sale Certificate from country of origin https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-full-registration
4. Review Process and Focus Areas
HSA conducts a detailed dual assessment:
- Device conformity to Essential Principles
- Medicinal substance quality, safety, and efficacy (including stability and impurity profiles)
- Clinical evidence for the combined product (often requiring specific studies)
- Risk-benefit balance considering synergistic or antagonistic effects
Prior reference approvals (e.g., from US FDA, EU, or other stringent authorities) may support the application but do not automatically qualify for abridged routes. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-full-registration
5. Timeline and Fees
- Target evaluation timeline: Approximately 210–300 working days (longer than standard Class D due to medicinal component review)
- Official fees for application and registration apply
- No standard expedited or priority pathway exists for these combination products https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-full-registration
6. Post-Registration Obligations
Upon approval:
- Implement enhanced post-market surveillance for both device and medicinal aspects
- Report adverse events, quality defects, and field safety issues promptly to HSA
- Notify HSA of any changes affecting the device or medicinal substance
- Comply with pharmacovigilance and device vigilance requirements
- Renew registration periodically (typically every 5 years) https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-full-registration
7. Practical Considerations
Full registration for Class D medicinal product devices ensures comprehensive oversight of complex drug-device combinations. Manufacturers should prepare integrated dossiers with strong clinical evidence for the combination and engage early with their Authorized Representative. Collaboration between device and pharmaceutical experts is often necessary. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-full-registration
This pathway safeguards patient safety for high-risk combination products in Singapore. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-full-registration
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