On June 13th 2022, the MDA has announced the exemption of conformity assessment process for registration of COVID-19 test kits either for personal or professional use via the Circular No.1/ 2022. The approval was decided during the MDA members meeting that was conducted on May 9th 2022. The implementation will
Endorsed by the Food and Drug Administration of the Department of Health, the Philippines Bureau of Internal Revenue has issued the Revenue Memorandum Circular No. 66 – 2022, providing information and guidance to all internal revenue officers, employees and others. This information is related to the letter of Dr. Oscar
Any individual, company or health facility involved in providing medical services must apply for the Medical Device Registration and Establishment License, as defined in Sections 5 and 15 of the Medical Devices Act 2012 (Act 737). An investigation and subsequent results of the compliance monitoring activities conducted by the MDA,
FDA Circular No.2022-003 MARKETING AUTHORIZATION & DISTRIBUTION/OFFER FOR SALE The Philippine Food and Drug Administration (FDA) has announced a notice to the public regarding the banning of all mercury-added thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes. This Circular aims to totally ban the
First edition guidance on the re-registration of registered medical device was issued by the Ministry of Health Malaysia on 3 June 2022. The Medical Device Authority (MDA) published the guidance document to provide information and explanation to the establishment on how to submit re-registration of registered medical device application under
The Medical Device Control Division, Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health issued an announcement on the Thailand FDA – HSA Singapore Regulatory Reliance implemented for Class 2-4 IVDs and non-IVDs medical devices effective from 1 June 2022. The registrant in Singapore who obtained
Subscribe to our Newsletter
Be the first to know about critical medical device regulation changes, market entry requirements, and industry shifts.
