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Australia: Therapeutic Goods Amendment (2016 Measures No 1) Bill 2016
Australia: Consultation held on future regulation of low risk products, including certain Class I medical devices
Australia: Guidance issued on clinical evidence for medical devices
China: Medical equipment inspection fees abolished
China: Revised rules for the supervision and management of medical device recalls took effect on 1 May 2017
China: Review timeframes could be reduced for certain submissions under new proposals
China: CFDA makes minor adjustments to classification rules for in vitro diagnostic reagents
China: Technical guidelines published on the security of medical device networks
China: New standard for medical device Quality Management Systems in force from 1 May 2017
India: Medical Devices Rules, 2017 are a first step towards full medical device regulation
India: Enforcement action to be taken against medical devices notified as drugs that fail to display Maximum Retail Price
Japan: Four new innovative devices able to receive support through Sakigake Designation
Korea: Medical device sales blocking system introduced to aid product recalls
Malaysia: Export-only devices exempt from conformity assessment and labelling requirements
Malaysia: New guidance issued on registration of combination products
Malaysia: Notification of exemption from registration for medical devices intended for clinical research or performance evaluation
Saudi Arabia: New guidance on importing medical devices, including IVDs, and non-medical IVDs for educational or non-clinical research purposes
Saudi Arabia: Requirements for importing distillation apparatus are specified in a new guidance document
South Africa: Licensing timeframes specified for manufacturers, wholesalers and distributors of medical devices and IVDs
Taiwan: Amendments proposed to annexes to Regulations for Governing the Management of Medical Devices
Vietnam: Registration now required for all imported medical devices
Click here for the full article on Global Regulatory Press.
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