Singapore Industry is preparing for Product, Importer/Wholesaler Licence with GDPMDS compliance where HSA is looking at transition period...

Australia: Fees and charges proposed for 2020–2021 Australia: Regulatory changes for software, personalised medical devices and IVD...

Pursuant to the Law on the Government Organization dated 19/06/2015; in consideration of the proposal of the Minister of Health, the...

Breast Implant regulation: B.E. 2562 Main content revision from regulation B.E. 2540 Signed date: 7 November 2019 Announced date: 18...

The ASEAN Cosmetic Directive (ACD) is an agreement among ASEAN countries to harmonize the requirements of cosmetic products so as to...

The 8th ASEAN Medical Device Committee was held from the 7-8 August 2019 in Philippines. The table below shows the update on ASEAN...

The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of...

Executive Summary: The latest Asian Medtech Associations Regulatory Networking discussions extended to news from Malaysia, Vietnam,...

As of present, there are a total of 1,985 medical devices and 1,136 reagents registered. Currently in Cambodia, the AMDD is already...

MDA shed the light on the following statistics: Total establishment license: 2,300 Establishments; Manufacturers: 230 Authorized...

Myanmar releases updates on the various changes to their regulatory process in the most recent 7th AMDC Meeting. The Myanmar Department...

During the 7th AMDC Meeting, the medical device control division released updates on the pre-market and post-market control of medical...

In recent ASEAN meeting, Singapore HSA has reiterated the country's initiative to enhance the facilitation of immediate market access....

The AO 2018-002 provides guidelines governing the issuance of an authorization for a medical device based on the ASEAN Harmonized...

Current situation in Laos: 36 Companies involved in medical device market 1 medical device factory 98% of medical devices are imported...

Indonesia is attempting to simplify regulations by reducing the time needed for review, promoting easier access for license application...

The AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...

Singapore HSA has recently announced possible changes to the guidance documents GN-17 and GN-18. These changes are currently opened for...

ASEAN: The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines,...

Questions for ASEAN General Can we have the slides from the regulators update? What changes can to AMDD can be expected with EU MDR and...