- Jan 27, 2021
Special Access Routes for Covid-19 Related Products - ASEAN Countries
Singapore Industry is preparing for Product, Importer/Wholesaler Licence with GDPMDS compliance where HSA is looking at transition period...
- Feb 6, 2020
Asia, Africa, Middle East - Jan/Feb 2020
Australia: Fees and charges proposed for 2020–2021 Australia: Regulatory changes for software, personalised medical devices and IVD...
- Jan 8, 2020
Vietnam Officialised Amendments 03/2020/ND-CP to Decree No.36/2016/ND-CP & Decree No.169/2018/ND-CP
Pursuant to the Law on the Government Organization dated 19/06/2015; in consideration of the proposal of the Minister of Health, the...
- Jan 3, 2020
Thailand Breast Implant Regulation: B.E. 2562
Breast Implant regulation: B.E. 2562 Main content revision from regulation B.E. 2540 Signed date: 7 November 2019 Announced date: 18...
- Dec 26, 2019
ASEAN Cosmetic Directive (ACD) Annexes amendment
The ASEAN Cosmetic Directive (ACD) is an agreement among ASEAN countries to harmonize the requirements of cosmetic products so as to...
- Aug 28, 2019
ASEAN Medical Device Committee Meeting Updates in Philippines
The 8th ASEAN Medical Device Committee was held from the 7-8 August 2019 in Philippines. The table below shows the update on ASEAN...
- Mar 28, 2019
7th AMDC: ASEAN Borderline and Harmonized Classification documents released
The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of...
- Mar 28, 2019
ASEAN Updates for Malaysia, Vietnam: Asian Medtech Associations Regulatory Networking
Executive Summary: The latest Asian Medtech Associations Regulatory Networking discussions extended to news from Malaysia, Vietnam,...
- Dec 17, 2018
Cambodia recognises Drug-Device Combination Status in Singapore, Malaysia and Indonesia
As of present, there are a total of 1,985 medical devices and 1,136 reagents registered. Currently in Cambodia, the AMDD is already...
- Dec 17, 2018
Thailand FDA shares 2019 Medical Device Regulation Plan
During the 7th AMDC Meeting, the medical device control division released updates on the pre-market and post-market control of medical...