Representation for foreign manufacturers
Singapore Registrant
If a company does not have a physical establishment in Singapore, it is required to appoint a local authorized representative, also known as a Registrant. Any company that wants to manufacture, import, or supply medical devices in Singapore must obtain a dealer’s license, which is usually done by the Registration for foreign legal manufacturers.
More information
Additional Regulatory Requirements
Communication with HSA
All communication regarding the submission and Registration is done through MEDICS. HSA has a fully digitized platform used for all communication. When HSA has reviewed the documents and requires further information, a so-called Input Request (IR) is filled in. The Registrant (or other linked account) receives an automatic notification for this.
Since the submission and review are done online, HSA allows manufacturers to consult pre-market. This is called a pre-market consultation based on the medical device development, usually more clinically focused, or a pre-submission consultation focused on the device dossier and supporting documents.
All communication is usually done in English, and the submission file is also accepted in English.
GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
Do you need assistance with your strategy for HSA Medical Device Regulations in Singapore?
Qserve is your trusted partner for market access in Singapore.
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Medical Device Registration and IVDs
Achieve regulatory compliance
Our regulatory consulting specialists support market access in the Singapore device market. Based on your current compliance, we can conduct a gap analysis to determine the overlap and missing elements on how to complete the technical documentation efficiently. Qserve knows the essential requirements to ensure how to achieve regulatory compliance.
Regulatory timelines and fees
How long does it take to enter
the Singapore medical device market?
The turnaround times are depending on the risk class and the type of evaluation route:
- Class B: up to 160 working days
- Class C: up to 220 working days
- Class D: up to 310 working days
Important links and guidance
Where to find more information?