Refering to the announcement issued by the Medical Devices Authority (PBPP) regarding the full enforcement of medical device registration...

THE FIRST MEDTECH ASSOCIATIONS REGULATORY NETWORKING discussion, hosted by Medtech Insight and sponsored by the ARQon consultancy...

Australia: Therapeutic Goods Amendment (2016 Measures No 1) Bill 2016 Australia: Consultation held on future regulation of low risk...

Asia: Raft of guidance documents endorsed at 21st Annual Meeting of the AHWP Australia: Regulatory reform consultations Australia: MTAA...

Vietnam's Decree on Management of Medical Devices (No. 36/2016/ND-CP) is coming soon - probably sooner than expected for the unprepared....

Malaysia Device Authority of Malaysia (MDA) just recently published the medical device guidance document on the requirements for...

Closer to home, the Malaysian government recently announced the exemption of all types of Class A (lowest-risk) devices from conformity...