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
The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines For Application Of Authorizations At The Food And Drug Administration In Light Of The Extended State Of Public Health Emergency” The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines For Application Of Authorizations At The Food And Drug Administration
On September 23 2022, the MDA has announced the release of the Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027). This guidance document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737)
Subscribe to our Newsletter
Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!
