Understanding Singapore’s Regulatory Pathway for Medical Device Registration
The regulatory pathway for medical device registration in Singapore is administered by the Health Sciences Authority (HSA). This framework safeguards public health by ensuring that medical devices supplied in Singapore meet the required standards of safety, quality, and performance.
Obtaining product registration is a mandatory step before any medical device can be imported or supplied in Singapore. The process involves several preparatory stages — from determining device classification to online submission through HSA’s SHARES system
Pre-Submission Requirements and Initial Determinations
Before submission, companies should ensure all prerequisites are in place:
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Business Registration: Register the business with the Accounting and Corporate Regulatory Authority (ACRA).
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HSA Access: Obtain company access through the Client Registration and Identification Service (CRIS) to use for online transactions.
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Determine Product Status: Verify that the product qualifies as a Medical Device or In Vitro Diagnostic (IVD) device under the Health Products Act.
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Intended Market Supply: Product registration applies only to devices supplied within Singapore. Devices imported solely for re-export follow separate Special Access guidance.
Risk Classification and Registration Requirements
The product’s risk class determines its registration pathway:
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Class A:
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Registration not required.
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Must be listed under the Class A exemption list (GN-22).
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Class B, C & D:
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Registration required.
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Determine grouping based on GN-12-1 and GN-12-2.
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Refer to GN-13 (General Devices) and GN-14 (IVDs) for classification details.
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Submission Preparation and Online Filing
For devices that require registration (Class B, C, or D):
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Follow the ASEAN Common Submission Dossier Template (CSDT), as guided in GN-15.
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Use specific guidance for:
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General Medical Devices: GN-17
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In Vitro Diagnostic Devices: GN-18
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All submissions are made electronically through SHARES system
Product registration can be completed alongside an application for a Dealer’s Licence. Only licensed dealers may manufacture, import, or wholesale medical devices in Singapore.
Quality Management System (QMS) Requirements:
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Manufacturer’s Licence: ISO 13485 or MDSAP certificate.
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Importer’s / Wholesaler’s Licence: ISO 13485, MDSAP, or GDPMDS certification.
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Class A Dealers: May submit a declaration of conformity to a QMS.
Singapore’s medical device registration pathway operates as a structured, transparent system — ensuring that both the device and the company meet rigorous regulatory and quality standards before entering the market.
This process, though detailed, ultimately builds trust, safety, and global recognition for medical device companies operating in Singapore.
If you are planning to register a medical device or set up as a medical device dealer in Singapore, understanding the HSA pathway is your first step toward compliance success.
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