The Regulation (EU) 2023/607 was released on 15 March 2023 with the extension of the transition period and removal of the ‘sell-off’...

Medical Device Authority of Malaysia (MDA) announced the implementation of the electronic medical device registration certificate...

On 18th January 2023, the National Medical Products Administration (NMPA) announced the initiatives for general cosmetics filing and...

FDA recently (in May 2023) released the revised guidance titled “Q9 (R1) Quality Risk Management” specifically focused on the quality...

Product information is important in aiding healthcare professionals in making decisions and assisting patients in getting medical...

Guidance on clinical evidence requirements for medical devices has been published by Health Canada on November 2022. The guidance is for...

The Food and Drug Administration (FDA) of the Philippines released FDA Circular 2021-002-C on 29 March 2023 for the regulatory...

Majority of the medical devices are connected to the internet and various networks in order to provide better health care. This may...

The Kingdom of Saudi Arabia published guidance regarding licensing medical device establishments in July 2022 under the government...

Due to the uncontrollable demands nationwide, there were medicine and medical device shortages in a short time. On top of that, no data...

The Ministry of Health (MOH) of Malaysia has publicly announced the called-off registration and product recall of Pholcodine on 20 March...

On June 2022, a cabinet of ministers voiced concern about the implementation challenges that may trigger the delay or discontinuity of...

The concerns about highly disproportionate numbers of identifiers in the European Database of Medical Devices (EUDAMED) have risen due to...

An announcement made by the Indian Ministry of Health and Family Welfare (MOHFW) on October 2022 stated the exemption of Class A...

European Commission (EC) has foreseen the possibility of disruption occurring for medical device supplies as there are many issues...

The National Medical Products Administration (NMPA) of China has introduced Medical Device Master File System (MDMF) in 2021 with...

Thailand Food Drugs and Administration (FDA) has released a Specialist Review guideline solving confusion in deciding which device would...

The National Medical Product Administration of China (NMPA) and the National Health Commission have announced the implementation of...

On 1 August 2022, the Health Sciences Authority of Singapore (HSA) has launched Voluntary Notification System (VNS). Voluntary...

On 3rd March 2023, the Vietnamese Ministry of Health (MOH) published Decree to complement the proposed decree on delays and amendments on...