The Health Sciences Authority (HSA) of Singapore was added to the Medical Device Division (MDD) acceptance list for marketing approval starting on 2 April 2024, joining South Korea (approved in 2023), Mainland China (approved in 2022), and GHTF 5 countries (US, Canada, Australia, EU, and Japan approved on 2004).
HSA’s recognition is intended as medical devices compliance support for Hong Kong to the “Essential Principles of Safety and Performance of Medical Devices (Technical Reference: TR-004)”. With this new addition, several Guidance Notes (GN-02, 03, 04) and Application Forms (MD101, 102) are required for updates.
Among the updates are modifications of the accepted Marketing Approvals scope, the addition of time for vetting and approving applications, and the replacement term of “Make” to “Manufacturer”. Application Form that was previously named “MD-C2&3&4” is renamed as “MD101”.
Clause 3.2 & 5.1 in GN-04 were revised by acquiring manufacturers to ensure the medical device complies with the conformity assessment requirements of MDACS either through conformity assessment audits by CABs or an alternative route stated under Clause 5. The Local Responsible Person must be responsible for ensuring all MDACS requirements have been completed before submitting their listing application.
The alternative route mentioned can be found under Clause 5.1 which the manufacturer may present the approvals from GHTF 5 members or Marketing Approvals from Mainland China, South Korea, or/and Singapore, as proof that the medical device conforms to the Essential Principles of Safety and Performance of Medical Devices (GN-01).
Source: Medical Device Division (MDD)
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