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Medical Devices-Asia and ROW Regulatory News-Nov. 2023

  1. Reusable medical devices that are initially provided to users in sterile form and require users to reprocess (i.e. clean, disinfect or sterilize) after first use and before use by subsequent patients.
  2. Reusable medical devices that are initially provided to the user in a non-sterile form and require the user to process (i.e. clean, disinfect or sterilize) for first use and reprocess after each use.

From 1 December 2023, all advertisement applications that have been completed and completed with a checklist must be sent via email to [email protected]. Applications received in hard copy will not be processed.

  1. One of the main objectives is to strengthen the linkage mechanisms with companies in the sector.
  2. With a market value of more than $16 billion, Mexico is one of the leading global suppliers of medical devices.
  • To register a medicine (prescription, OTC or complementary) on the ARTG
  • To include a biological on the ARTG that requires evaluation of information
  • To include a medical device (including IVD) on the ARTG if you have been advised that it will be audited and requested to provide information for the audit
  • To list an assessed listed medicine (where information is required for evaluation) For medical device (including IVD) conformity assessment certification
  • For evaluation of new ingredients for use in listed medicines
  • To vary the ARTG record which requires supporting information
  • Statement;
  • Pictorial representation; or
  • Design

Administrative extension of validity for registration certificates in the medical equipment register

  • Medical equipment registered in the register of medical accessories and devices maintained by the Ministry of Health and the validity of the approval of the Amr has expired between December 1, 2022 and December 30, 2024.
  • Medical equipment for which registration renewal approval was granted, the expiration date of which is between 12.1.2022 and 12.30.2024.