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...

The Food and Drug Administration (FDA) has designated an AAMI standard and technical information report (TIR), both published earlier...

Background: The MDR will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices...

Background: The IVDR will replace the existing In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). The transitional period...

Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical...

Czech Republic: Form released for accessing online reimbursement system EU: Corrigenda published to Regulations 2017/745 and 2017/746 EU:...

Canada: Medical device fees increased by 2% from 1 April 2019 Canada: ‘Medical Devices Regulations’ updated to refer to 2016 edition of...

Argentina: Procedure for requesting an import authorisation for a medical product Argentina: Regulatory controls established for...