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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

March 21, 2023

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

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

March 13, 2023

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

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

March 13, 2023

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

Philippines: Online Selling Of FDA Certified COVID-19 Self-Administered Test Kits

February 22, 2023

The Philippines Food and Drug Administration (FDA) issued an advisory, lifting the prohibition of online selling of FDA Certified COVID-19 Test Kits including Self-Administered COVID-19 Test Kits, pursuant to FDA Advisory No. 2022-0107-A Lifting of the FDA Advisory No. 2022-0107 entitled “Reiteration on Prohibition of Online Selling of FDA Certified

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Singapore: Announcement: Public Consultation For The Proposed Framework And Implementation Of The Cybersecurity Labelling Scheme For Medical Devices, CLS (MD)

February 22, 2023

As ‘smart’ medical devices are commonly used in the health settings with increased connectivity to the cyber world, it’s inevitable to have an increased potential risks of cyber-attacks as well. Thus, at the Singapore International Cyber Week 2022, the Ministry of Health (MOH), Cyber Security Agency of Singapore (CSA), Health

Thailand: Collaborative Registration Procedure (CRP) of Thailand FDA – WHO for In-Vitro Diagnostic Products

February 22, 2023

The Medical Device Control Division, Thai FDA has been recognized by WHO as a reference agency, which allows Thailand to participate in the Collaborative Registration Procedure (CRP) program, that can shorten the duration of registration. The Thai FDA will assess the performance and safety of the medical device in cooperation

Regulatory Updates

Regulatory Updates

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

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

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

Philippines: Online Selling Of FDA Certified COVID-19 Self-Administered Test Kits

Singapore: Announcement: Public Consultation For The Proposed Framework And Implementation Of The Cybersecurity Labelling Scheme For Medical Devices, CLS (MD)

Thailand: Collaborative Registration Procedure (CRP) of Thailand FDA – WHO for In-Vitro Diagnostic Products

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Regulatory Updates

Regulatory Updates

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

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

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

Philippines: Online Selling Of FDA Certified COVID-19 Self-Administered Test Kits

Singapore: Announcement: Public Consultation For The Proposed Framework And Implementation Of The Cybersecurity Labelling Scheme For Medical Devices, CLS (MD)

Thailand: Collaborative Registration Procedure (CRP) of Thailand FDA – WHO for In-Vitro Diagnostic Products

Countries

Categories

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Main Pages

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