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Singapore: Minor Update on HSA Guidance on Labelling for Medical Devices

Leave a Comment / Regulatory updates, Singapore / By Kia UP

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 followings are the added points […]

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Vietnam: Procedures For Receiving, Appraising, Issuing, Post-Inspection, And Withdrawing The Circulation Number Of The Medical Devices

Leave a Comment / Regulatory updates, Vietnam / By Kia UP

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 the case of fast-track and

Vietnam: Procedures For Receiving, Appraising, Issuing, Post-Inspection, And Withdrawing The Circulation Number Of The Medical Devices Read More »

Malaysia: Guideline for Re-Registration of Registered Medical Device by MDA

Leave a Comment / Malaysia, Regulatory updates / By Kia UP

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 shall undergo conformity assessment via

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Philippines: FDA Issued FDA Circular 2022-008: Guidelines For The Abridged Processing Of Application For Registration Of Medical Devices Approved By The National Regulatory Authority Of Any ASEAN Member Country

Leave a Comment / Philippines, Regulatory updates / By Kia UP

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 B, C and D medical

Philippines: FDA Issued FDA Circular 2022-008: Guidelines For The Abridged Processing Of Application For Registration Of Medical Devices Approved By The National Regulatory Authority Of Any ASEAN Member Country Read More »

Philippines: 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”

Leave a Comment / Philippines, Regulatory updates / By Kia UP

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 In Light Of The Extended

Philippines: 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” Read More »

Malaysia: MDA Issued Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027)

Leave a Comment / Malaysia, Regulatory updates / By Kia UP

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) and the regulations under it.

Malaysia: MDA Issued Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027) Read More »

Singapore: Minor Update on HSA Guidance on Labelling for Medical Devices

Vietnam: Procedures For Receiving, Appraising, Issuing, Post-Inspection, And Withdrawing The Circulation Number Of The Medical Devices

Malaysia: Guideline for Re-Registration of Registered Medical Device by MDA

Philippines: FDA Issued FDA Circular 2022-008: Guidelines For The Abridged Processing Of Application For Registration Of Medical Devices Approved By The National Regulatory Authority Of Any ASEAN Member Country

Philippines: 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”

Malaysia: MDA Issued Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027)

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October 2022

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