Category: Medical Device

Medical Devices-Asia Regulatory News Roundup, Nov 2022

December 8, 2022
Medical Device

INDIA (CDSCO) 1. List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017This Directorate...

Asia Regulatory News, Bahrain Regulatory News, India Regulatory News, Malayasia Regulatory News, Medical Devices Regulatory News

Medical Devices – USA, Europe, Asia Regulatory News – Nov 2022

November 30, 2022
Medical Device

Asia Philippines FDA Publishes Circular on The Abridged Processing of Medical Devices Registration with Approval by The NRA of Any ASEAN Member Country Philippines FDA issues Circular No. 2022-008...

Asia, Devices, Europe, FDA, HSA, IVDR, Liver Cancer, MDCG, Regulatory News, South Africa, USA

Medical Devices–USA/Europe Regulatory Updates Roundup, Oct 2022

November 8, 2022
Medical Device

EUROPE MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 The document has been endorsed by the Medical Device Coordination Group...

Medical Devices – Asia Regulatory Updates Roundup, Oct 2022

November 3, 2022
Medical Device

INDIA (CDSCO) Extension of last date for filing statutory forms prescribed under DPCO, 2013-reg As several representations requesting for extension of last date for filing statutory Forms- III,...

Medical Device – Regulatory & Product Intelligence

November 2, 2022
Medical Device

The Medical Device industry is one of the largest industries in the healthcare sector, with significant growth in the last few years. The industry is undergoing continuous transformation to comply...

MHRA Guidance for Medical Device Manufacturers on Vigilance

October 26, 2022
Medical Device

Adverse incidents involving medical devices that occur in the UK must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA). Once a medical device has been placed on the UK...