AHWP: Proposed competency framework for medical technology regulators IMDRF: Principles and practice for medical device cybersecurity are...

It was confirmed by the European Commission on 30 October 2019 that the Medical Device Regulation (MDR) EUDAMED will be delayed for two...

Non-corrective contact lens is regulated as medical devices by the Medical Device Authority (MDA). According to the Medical Device...

MDA announced the training for competency module (regulatory requirements) for biomedical technical personnel. The module is designed to...

Australia: 2019 fees and charges released by the Therapeutic Goods Administration Australia: Conformity assessment standards for medical...

Albania: Amendments proposed to ‘Law on Medical Devices’ EU: New MDCG documents on Notified Bodies, the person responsible for regulatory...

Canada: New fees and performance standards for medical devices effective 1 April 2020 Canada: New medical device incident reporting...

Brazil: Parametric release may replace sterility test for ethylene oxide sterilised devices Ecuador: Proposed revision of PRTE INEN No...

IMDRF: Guidance drafted on regulatory pathways for personalised medical devices IMDRF: Comments solicited on terminologies for...

China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...

The Hong Kong Medical Device Control Office (MDCO) will launch an Expedited Approval trial scheme to streamline application and approval...

Medical Device Pre-market Registration A submission guide that maps the various modules in our MEDICS system to the ASEAN CSDT dossier...

CDRRHR shared the following statistics: Manufacturers/Repacker: 74 Trader: 51 Distributors – Wholesalers, Importers, Exporters: 2,470...

Myanmar FDA shared the following statistics: Local Manufacturer Manufacturers for low and medium risk device: 6, excluding small and...

Circular Letter No. 1 Year 2019: Post-market Responsibility for Manufacturer and Authorized Representative Who Have Closed Their...

Medical Device control system In Laos there are 72 Import drug-medical device companies, who are representative for local distribution....

Indonesia Encourages Investment Economic growth shows an increasing trend, and this includes the Pharma and Medical Device Industry New...

Ministry of Health, Cambodia issued Prakas № 2387 dated 12 July 2019 on Procedure of Online Registration System for Drug and Manufacturer...

The Thai Food and Drug Administration released the amended Medical Device Act (2nd edition) 2019 which will replace its predecessor, the...

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