- Aug 28, 2019
Malaysia: Medical Device Regulatory Updates
Circular Letter No. 1 Year 2019: Post-market Responsibility for Manufacturer and Authorized Representative Who Have Closed Their...
- Jun 28, 2019
Asia, Africa & Middle East - Jun 2019
Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical...
- Jun 28, 2019
Post Market Step up enforcements by Singapore HSA and Malaysia MDA
SINGAPORE: HSA Informs Public Regarding Risk of Breast Implants BIA-ALCL is a cancer of the immune system and not a type of breast...
- Jun 28, 2019
Malaysia MDA Announcement: Placement in the Market and the Use of Non-registered Device without Clin
On 24 Apr, Malaysia MDA made an announcement regarding the placement in the market and use of non-registered device without clinical...
- Jun 28, 2019
Asia Reg News: AHWP Catch-up, Korea, Malaysia, Indonesia and Vietnam Updates
Executive Summary: Part 1 of this month's Asian Medtech Associations Regulatory Networking discussions features Asean medtech market...
- Mar 29, 2019
Asia, Africa & Middle East - Mar 2019
Australia: Reclassification of surgical mesh devices and publication of associated guidance Australia: Proposed fees and charges for...
- 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...