In line with GDPMDS, HSA Singapore also published minor updates of guidance document entitled GN-06 R3 Guidance on Distribution Records on 01 Nov 2022 which assist product owners on the determination of projected useful life of the medical device. Projected useful life of a medical device is dependent on various
Health Sciences Authority (HSA) Singapore has reviewed and validated the medical device guidance document entitled GN-33 R1.2 Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices Revision 1.2 on 01 Nov 2022 to ensure its accuracy. This guidance document serves to provide advice for application of
The Health Sciences Authority (HSA) Singapore published a minor update to guidance document, GN-32: GUIDANCE on Labelling for Medical Devices Rev 2 (dated September 2022). This update provides alignment to GN-36: Guidance on Medical Device Unique Device Identification (UDI) System mandating the UDI compliance for medical devices in Singapore. The
On 12 September 2022, the Vietnamese Ministry of Health issued the QT.TBCT.15 entitled “Procedures for Receiving, Appraising, Issuing, Post-Inspection, and Withdrawing the Circulation Number of The Medical Devices. The regulation applies to the evaluation of all registration routes of medical devices class C and D, and its post inspection with
On September 15 2022, the MDA has issued second edition of guideline document entitled “Re-Registration of Registered Medical Device” (MDA/GL/08). The following information are added on the guideline: Applicant is not allowed to submit re-registration application concurrently with change notification application; and Requirements on Pre-Market Clearance / Approval All application
On 27 September 2022, the Philippines FDA issued FDA Circular No. 2022-008 which aims to provide guidelines on the abridged processing of application for registration of medical devices with product approval issued by the NRA of any ASEAN member country under the AMDD-CSDT requirements. This Circular shall apply to Class
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