SINGAPORE Health Products Regulatory Forum (held 18-19 May 2017)
May 31, 2017
To drive the Singapore Committee on the Future Economy (CFE), HSA will be putting in place the following:
Singapore Pre-market consultation scheme i.e. medical device development and pre-submission for Singapore registration; and
Singapore Priority review scheme option of full evaluation registration route for product in the 5 healthcare focus areas e.g. Cancer, Diabetes, Ophthalmic, Cardiovascular and Infectious disease, whereby the product is designed and validated to meet unmet clinical needs.
HSA continue to minimize regulatory burden and compliance costs by Revising Class A and B medical device requirements
Class A sterile device no longer require registration like current Class A non-sterile device;
Registered Class A medical device to be included in the Singapore Medical Device Register(SMDR) or database;
Class A device dealers no longer require certification for GDPMDS (importer, wholesaler) or ISO13485 (manufacturer). Company self-regulatory approach to maintain the quality system where it may be subjected to random quality compliance checks by the Authority; and
Class B device immediate registration route without waiting for product approval is now extended to devices with 2 reference agencies approval, or, 1 country with 3 years of safe marketing history. (Previously, immediate route was only for those with 2 reference agencies approval and 3 years of safe marketing history). Class B device expedited registration route will soon no longer be available.
In terms of implementation, although no confirmed dates yet by HSA, based on a discussion, it is tentatively planned to be in September 2017.
Class B and C standalone mobile application medical device immediate registration route (1 reference agency approval) is targeted to begin in early 2018 as per conversation with HSA.