China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...

SINGAPORE: HSA Informs Public Regarding Risk of Breast Implants BIA-ALCL is a cancer of the immune system and not a type of breast...

Updates on Eurasian Medical Device Regulations ARQon summarizes the most significant new medical device regulations changes in the...

Health Canada has revised the guidance document titled "Management of Applications for Medical Device Licences". This document outlines...

On 7 May 2019, FDA issued a document, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”. This...

Executive Summary: This month's Asian Medtech Associations Regulatory Networking discussions is split into two parts, the first being a...

e-Registration Submission System NMPA plans to publicise the usage of its electronic Regulated Product Submission (eRPS) system. The eRPS...

NB Listed in European Commission’s New Approach Notified and Designated Organisations (NANDO) To date, two Notified Bodies have been...

On 25 March 2019, South Korea's Ministry of Food and Drug Safety (MFDS) published a notification titled "Professional revision of medical...

On 24 Apr, Malaysia MDA made an announcement regarding the placement in the market and use of non-registered device without clinical...

Executive Summary: Part 1 of this month's Asian Medtech Associations Regulatory Networking discussions features Asean medtech market...

Medical Device Regulations China's National Medical Products Administration (NMPA) have published the following registration guidelines...

New Medical Device Act Recently, Thailand FDA has just announced new Medical Device Act (more information will be given in an update...

PP JPH has been signed by the President on 29 April 2019 and promulgated on 3 May 2019. However, the PP copy has not yet been published,...

Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices On 12 April, the...

On 12 Apr 2019, the US FDA published the "Finalized List of Accessories Suitable for Class I" medical devices document, as required by...

The International Medical Device Regulators Forum (IMDRF) is a forum for regulators to discuss directions in medical device regulatory...

Below are the news related to Drug Regulatory Authority of Pakistan (DRAP). For registration of drugs in Pakistan, DRAP has made it...

On March 1st, 2019, ANVISA published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with the migration of...

Australia: Reclassification of surgical mesh devices and publication of associated guidance Australia: Proposed fees and charges for...