Medical devices and drugs in Singapore are regulated by the Health Sciences Authority (HSA) under the Singapore Ministry of Health (MOH). All medical devices and pharmaceutical products imported and/or sold in Singapore must be registered, regardless of risk class (except those exempted from registration). The licensing of dealers (manufacturers, importers, and wholesalers) is also mandatory.
Local Authorized Agent (Registrant) for Medical Devices
- Applications to the HSA can only be made via MEDICS (Medical Device Information and Communication System) e-Services. Thus, companies who wish to register their products with the HSA must appoint a local authorized agent who is registered with the ACRA (Accounting and Corporate Regulatory Authority) in order to register an account with the HSA.
Local Authorized Agent (Registrant) for Pharmaceuticals
- Only a locally registered company can apply for a drug product license via PRISM (Pharmaceutical Regulatory Information System) and act as the product license holder, who is responsible for the safety, quality and efficacy of the product placed on the market.
- A medical device or drug company that does not have its own locally registered office in Singapore can appoint a locally registered company (either a distributor or an independent third party) to act as their local authorized agent and submit registration applications on their behalf.
- Dealers of medical device and pharmaceutical products must possess the appropriate dealer’s license depending on the activity they carry out in relation to the medical product – namely, manufacturer’s license, importer’s license, and/or wholesaler’s license.
- For medical devices, certification for Good Distribution Practice for Medical Devices (GDPMDS) is required in order to apply for an importer or wholesaler’s license.
Pacific Bridge Medical can act as your Local Authorized Agent (Registrant) in Singapore. To find out more about the Singaporean medical regulations and local representation system, contact us for a free consultation with our expert regulatory consultants.
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