Regulatory updates Archives

businessman in blur is working at office desk with phone in his hands and document in front if him, focus on folders

Malaysia: MDA Issued Second Edition Guidance Document (MDA/GD/0061) Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device

March 24, 2023

On March 9 2023, the MDA has announced the release of the Second Edition Guidance Document “Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device” (MDA/GD/0061). This guidance document was prepared by the Medical Device Authority (MDA) to provide the classification of a list of products used for rehabilitation, physiotherapy, and

Close up business man reaching out sheet with contract agreement proposing to sign

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

Cyber security analyst working on a laptop

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

Regulatory Updates

Malaysia: MDA Issued Second Edition Guidance Document (MDA/GD/0061) Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device

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)

Countries

Categories

Sign up for our regulatory roundup delivered once a month to your inbox

Main Pages

Address

E-mail Address

Phone Number

Stay Ahead in Southeast Asia's Medical Device Market!