Australia: Updates to the definitions of medical device, accessory, instructions for use, user, and reusable surgical instrument
Australia: Changes to the definition of, and requirements for, systems and procedure packs
Australia: Changes to ARTG inclusion process for certain Class I devices
Australia: Reminder about deadlines for up-classification of surgical mesh devices
Australia: Expedited recall system established for faulty or unauthorised COVID-19 devices
Australia: New compliance dashboard for post-market medical device reviews
Australia: Advice provided on TGA’s approach to certain delays to conformity assessment re-certification
Australia: Second consultation on implementing a UDI system is underway
Australia: Adverse event reporting enhancements proposed
China: First phase of UDI implementation delayed until 2021
China: Simplified registration process for imported devices that move production to China
China: Updated catalogue of Class III devices requiring clinical trial approval has been published
China: New medical devices and IVDs to be exempt from clinical trials
China: Medical device registration certificates to be issued electronically as part of pilot
China: Feedback sought on cybersecurity guideline
China: New medical device industry standards published
China: Basic safety and performance requirements for various medical electrical equipment
China: Two new standards for medical electrical dental equipment
Egypt: Four standards drafted for intravascular catheters
Egypt: Two draft standards proposed relating to medical suction equipment
India: Proposed list of medical device product classifications released
India: Online applications mandatory for Certificates of Free Sale, Market Standing Certificates, and Non-Conviction Certificates
India: Fees not required for simple address change of an Authorised Agent
Israel: Updated mandatory standard on cardiac defibrillators has entered into force
Kenya: New standard sets specifications of kidney trays
Korea (Republic of): Proposed classification changes for medical respirators and SaMD
Korea (Republic of): Fee increases, extra review staff, and changes to fee provisions are proposed
Korea (Republic of): Draft Act on developing and supplying medical products in response to an emergency
Malaysia: Updated policy on implementation and enforcement of rules relating to the refurbishment of medical devices
Malaysia: Guidance on requirements for registration of Conformity Assessment Bodies
Malaysia: New guidance on the requirements for medical device advertisements
Russian Federation: Regulatory changes for software as a medical device
Russian Federation: Consultation held on proposed changes to rules for conducting biological evaluation studies
Saudi Arabia: UDI database launched and compliance dates set
Saudi Arabia: Further extension on use of evidence of regulatory compliance in other jurisdictions
Saudi Arabia: Six updated guidance documents published
Singapore: CNs arising from updates to labels and IFU triggered by the EU MDR and IVDR
South Africa: SAHPRA has relocated
South Africa: Application process for a clinical evaluation of a medical device or IVD
South Africa: Additional guidance provided on performance evaluation of point-of-care COVID-19 serology antibody test kits
South Africa: Communication to stakeholders on licensing and regulatory requirements for medical and respirator masks during the COVID-19 pandemic
Taiwan: Proposed fee increases for licensing and registration of medical equipment
Taiwan: Proposed rules for classification of medical devices
Taiwan: Quality of imported medical masks to be examined
Tanzania: Standard drafted to set specifications for surgical face masks
Uganda: Standard drafted on petrolatum gauze
Vietnam: Certain medical sector fees reduced until end of 2020
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