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

October 13, 2022

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

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

October 12, 2022

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

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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

October 11, 2022

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

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”

October 10, 2022

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

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

October 2, 2022

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)

Malaysia: Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits by MDA

September 29, 2022

MDA has released a new guideline document for the registration of Orthopoxvirus (Monkeypox) IVD Test Kits, entitled “Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits” (MDA/GL/09), First Edition” dated September 2022. The guidance document entails the registration requirements, registration process flow, classification, evaluation timeline, application and registration fees of

Regulatory Updates

Regulatory Updates

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)

Malaysia: Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits by MDA

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Regulatory Updates

Regulatory Updates

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)

Malaysia: Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits by MDA￼

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Malaysia: Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits by MDA