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Vietnam: Vietnam Government released Decree No. 07/2023/NĐ-CP amending and supplementing some articles of Decree No. 98/2021/NĐ-CP about medical device management

On 03 Mar 2023, the Vietnam Government signed and released Decree No. 07/2023/NĐ-CP amending and supplementing some articles of Decree No. 98/2021/NĐ-CP about medical device management, which takes effect immediately. Some of the key highlights are mentioned below: Management of medical device prices Listing of prices of medical devices Organizations and individuals manufacturing and trading …

Vietnam: Vietnam Government released Decree No. 07/2023/NĐ-CP amending and supplementing some articles of Decree No. 98/2021/NĐ-CP about medical device management Read More »

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Singapore: Fifth Revision of GN-21: Guidance On Change Notification For Registered Medical Devices

FIFTH REVISION OF GN-21: GUIDANCE ON CHANGE NOTIFICATION FOR REGISTERED MEDICAL DEVICES The Health Sciences Authority (HSA) of Singapore issued a fifth revision of GN-21: Guidance on Change Notification for Registered Medical Devices. This new revised guidance has been made effective starting March 07th 2023. With this revised guidance, it is informed that the Safety …

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Malaysia: MDA Issued the First Edition Guidelines on “Notification of Custom-Made Medical Device” (MDA/GD/0064)

On March 1st 2023, the MDA released the First Edition Guideline Document “Notification of Custom-Made Medical Devices” (MDA/GD/0064). This guidance document is intended to provide guidance for the requirements of custom-made medical devices that are eligible to be exempted under Medical Order 2016.   It also specifies the specific requirements and notification process to obtain permission …

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Philippines: Reiteration Against Unethical Business Practices Related To The Promotion Of Prescription Pharmaceutical Products And Medical Devices (PPPMD)

The Philippines Food and Drug Administration (FDA) issued an Advisory No. 2022-2045 on 29 December 2022, to warn all Prescription Pharmaceutical Products and Medical Devices (PPPMD) companies, and healthcare professionals (HCPs) not to engage in unethical business practices as mentioned in the provisions of Administrative Order (AO) No. 2015-0053 entitled “Implementing Guidelines on the Promotion …

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Thailand: Notification of the Ministry of Public Health RE: Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565 2022

On 09 December 2022, the Thai FDA issued a clarification on the Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565, that has become effective on 03 December 2022. With this new regulation, all physical therapy products will be classified as either Class A, B or C medical devices, requiring …

Thailand: Notification of the Ministry of Public Health RE: Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565 2022 Read More »

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Malaysia: Draft guidance for requirements on certificate application of CFS, MC and CFS EO medical devices

On 23 December 2022, Malaysia’s Medical Device Authority (MDA) has released a draft guidance document for the requirements of application of certificate of free sale (CFS), manufacturing certificate (MC) and certificate of free sale for export only (CFS EO) medical devices. This draft guidance document will serve as a revised version of MDA/GD/0045 that was …

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Malaysia: Latest License Terms For Renewal Establishment License By The MDA

On 13 December 2022, the Medical Device Authority of Malaysia (MDA) has published an announcement to emphasize the requirement for applying renewal of establishment license. The establishments (local manufacturer, authorized representative, distributor, and importer in Malaysia) shall apply for renewal of its establishment license at least 90 days before the expiry date of the licence, …

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Malaysia: Medical Device Authority (MDA) Amends Policy for Control over Orphaned, Obsolete and Discontinued Medical Devices

On June 16th 2022, the MDA has announced an amendment to the policy for control of orphaned, obsolete and discontinued medical devices in any facility including hospitals and health facility institutions.   Originally contained in PBPP Circular Letter No. 2 of 2018 (Revision 2) the amendment was passed through the issuance of MDA Circular Letter …

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Malaysia: Medical Device Authority (MDA) Improves the Policy for Control of Medical Device Refurbishment

On June 16th 2022, the MDA announced that the policy for control of medical device refurbishment activities contained in PBPP Circular Letter Number 1 Year 2016 (Revision 2) has been improved through the issuance of MDA Circular Letter Number 3 Year 2022. The improvements to this policy are effective as of May 9th 2022 and …

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Malaysia: MDA Announced Exemption of Conformity Assessment Process for the Registration of Covid-19 Test Kit

On June 13th 2022, the MDA has announced the exemption of conformity assessment process for registration of COVID-19 test kits either for personal or professional use via the Circular No.1/ 2022. The approval was decided during the MDA members meeting that was conducted on May 9th 2022. The implementation will be effective on the same …

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