Asia, Africa & the Middle East - Nov 2020

  • 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

Click here for the full article on Global Regulatory Press.

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