China, NMPA announces the publication of guidance document on medical device registration
China, NMPA announces the publication of this guidance document to further strengthen the administration and supervision on medical device registration, …
Japan, Updated guidance on biocompatibility testing of medical devices
Japan, Updated guidance on biocompatibility testing of medical devices Updated guidance relating to biocompatibility testing of medical devices was released …
USA, FDA launched Guidance Snapshots
A brand pilot program has been launched in February 2020 by the US FDA on Guidance Snapshots. These new Guidance …
UK will not be acting as a leading authority for medicines during Brexit transition
UK will not be acting as a leading authority for medicines during Brexit transition. Medicines and Healthcare products Regulatory Agency …
USA, FDA’s launch of purple book, an online database for biologics
The US Food and Drug Administration launched the first version of the Purple Book, which is a searchable online database …
India’s central government to regulate all medical devices as drugs
All medical devices in India will be regulated as drugs under Drugs and Cosmetic Act of 1940 with effect from …
Implementation of eCTD for Clinical Trial Applications in Canada
Health Canada would be accepting certain clinical trial submissions in the format of electronic common technical document (eCTD) from 19 …
New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia
New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia Coming into effect on the 1st of …
Philippines’ executive order on medicine price cap
Philippines’ President Rodrigo Duterte officially signed the executive order which would see a cap set on selected medicines at a …