Singapore medical device regulatory framework
Singapore’s Health Sciences Authority (HSA) regulates medical devices available in Singapore. Almost all medical devices are regulated and require registration in the Singapore Medical Device Register. Only Class A medical devices are exempt. Class B, C, and D medical devices are subject to product registration requirements and evaluation by the HSA before they can be legally imported or distributed.
The current medical device regulation in Singapore is the Health Products (Medical Devices) Regulations 2010 Singapore is one of the original member states of the Association of Southeast Asian Nations (ASEAN) and its regulatory and classification schemes are informed by the ASEAN Medical Device Directive. HSA also maintains an extensive library of regulatory guidance to help manufacturers identify registration requirements and processes for their specific device.
Singapore medical device registration pathways
HSA’s registration evaluation framework allows device manufacturers to leverage current approvals from foreign regulators, including US FDA, EU (Notified Bodies under MDR/IVDR), Australia TGA, Health Canada, and Japan PMDA/MHLW. These pathways shorten the HSA's turnaround time and time-to-market. (Note that certain Class C and D devices cannot leverage these pathways even if they meet eligibility criteria, such as active implantable devices, certain high-risk IVD assays, certain joint replacements, etc.) Eligibility for each pathway is determined by the classification, reference market approval, and market history.
Device notifications and registrations do not expire but incur annual fees. Foreign manufacturers also need an in-country representative called a Registrant to liaise with HSA and hold their registration.
Notification Route (Class A only)
Class A medical devices are exempt from product registration but require a product notification submitted via SHARE. Applicants must hold a valid HSA dealer’s licence, either as a Manufacturer or Importer or Wholesaler, and maintain an appropriate Quality Management System in accordance with dealer licensing requirements. No technical dossier review is conducted. Notification is effective immediately upon submission. Refer to GN-22: Guidance for Dealers on Class A Medical Devices
Exempted from Product Registration for specific requirements for Class A devices.
Immediate Registration Route (Class B and C)
The immediate route is available to eligible devices that have obtained authorization from at least one or two HSA-recognized overseas reference regulatory agencies. Depending on the specific pathway, eligibility may also require a minimum of three years of marketing history in the reference jurisdiction, absence of global safety issues, and no prior rejection or withdrawal by HSA or any reference agency. Applications must include evidence of reference market approval, proof of marketing history where required, a declaration of no global safety concerns, and route-appropriate technical documentation. Approval is granted immediately upon submission, as long as all eligibility and submission criteria are met.
Abridged Evaluation Route (Class B, C, and D)
The abridged route requires approval from at least one HSA-recognized overseas reference regulatory agency. The application must demonstrate current authorization status in the reference market though reduced-scope technical documentation compared to a full evaluation is accepted. Turnaround time generally ranges from approximately 100 to 220 working days, depending on device classification.
Expedited Evaluation Route (Class C and D)
Expedited evaluation for certain Class C and D devices requires approval in one or two HSA-recognized overseas reference regulatory agencies, depending on the specific pathway, and in some cases at least three years of marketing history in the reference jurisdiction. The device must have no global safety issues and no prior rejection or withdrawal by HSA or any reference agency. Key documentation requirements include proof of reference approvals, proof of marketing history where required, a declaration of no global safety issues, and route-specific technical documentation. Published turnaround times are approximately 120 working days for eligible Class C devices and 180 working days for eligible Class D devices.
Full Evaluation Route (Class B, C, and D)
The full evaluation route applies to B, C, and D devices that do not have prior approval from any HSA-recognized overseas reference regulatory agency. Applications require comprehensive technical documentation and full evaluation by the HSA. The review timeline ranges from approximately 160 to 310 working days, depending on device classification and complexity.
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