In Singapore, medical devices are regulated by the Health Sciences Authority (HSA). Established in April 2001 under the Ministry of Health (MOH), the HSA is the statutory body responsible for regulating Western medicines, medical devices, complementary health products, cosmetics and other products. It has administrative enforcement powers as well as the independence and flexibility of a research institution.
Singapore is a member of the Association of Southeast Asian Nations (ASEAN), and its regulatory system is based on the ASEAN Medical Device Directive, the Health Products Act 2007 and the Health Products (Medical Devices) Regulations 2010. These set out how medical devices are classified in Singapore and the registration route for each class.
Under Singapore’s rules, apart from exempt products, medical devices of all classes must be registered with the HSA before they can be placed on the market.
The registrant or applicant must be a company registered in Singapore and must apply online via the HSA’s Medical Device Information and Communication System (MEDICS). All registered medical devices are listed on the Singapore Medical Device Register (SMDR). The registrant is the HSA’s key contact for the device’s market placement.
Some Class B, C and D devices already approved in the US, Europe, Australia or Japan can be registered faster or even immediately upon providing the relevant supporting documents.
Annual retention fees for the Singapore Medical Device Register (SMDR)
Conclusion
This is a series of educational articles introducing regulations and standards of the FDA, NMPA, GMP, CE MDR/IVDR and MDSAP.
EVERBIZ is happy to share medical device expertise with industry clients, and hopes our extensive practical experience in quality systems and product registration will be helpful.
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EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
Shanghai: Room 909, Building 1, Lane 111 Luxiang Road, Baoshan District, Shanghai, China; Germany: Landsberger Str. 155, 80687 München, Germany
Austria: Innsbrucker Bundesstraße 136/3, 5020 Salzburg, Austria
Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong
Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520
