Digitization of package inserts, which was decided as a result of the revision of the Act on Securing Quality, Efficacy, and Safety of...

The Indonesia Ministry of Health released an announcement (No. FR.01.01/3/0139A/2021) on 15 February 2021. The imported Rapid Diagnostic...

On 28 December 2020, the Central Drugs Standard Control Organization (CDSCO) released F.No.29/Misc/03/2020-DC (297). With effect from 01...

In April 2021, the Medical Device Coordinating Group (MDCG) of the European Commission has released a new guidance on the role of safety...

The European Commission’s Medical Device Coordinating Group (MDCG) has issued new guidance explaining the role of safety and performance...

The European Commission’s Medical Device Coordination Group (MDCG) offers guidance on clinical investigations under MDR, Regulation (EU)...

On 18 March 2021, China’s National Medical Products Administration (NMPA) has published a notice of the State Food and Drug...

China has published the final version of the updated Medical Devices Supervision and Administration Regulations on 18 March 2021 (Order...

Starting from 25 February 2021, Australia TGA changed their regulation on software-based medical device with a revision that establishes...

TGA has amended their Therapeutic Goods legislation and covered the prescription drug availability as well as protecting their citizen...

Local companies who manufacture, import, or supply medical devices by wholesale are required to be licensed by HSA. The type of dealer...

The Medical Device Authority (MDA) in Malaysia has established a new Guideline to help the industry and healthcare professionals in their...

Argentina: ISO 13485 and MDSAP certificates accepted to support GMP compliance Argentina: Extension of emergency registration mechanism...

Canada: Revised fees for medical device applications become effective on 1 April 2021 Canada: Changes to post-market surveillance...

Belgium: Exceptional measures end for surgical face masks Denmark: Relaxed labelling requirements for medical face masks extended by six...

Australia: Regulatory changes for custom-made devices apply from 25 February 2021 Australia: Reforms to the regulation of software-based...

EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation...

The Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on 1 September 2020, which related with how medical...

MOH Indonesia published Guidelines on the evaluation requirements on each document for Indonesia Medical device and IVD registration....

Two emergency exemptions that were made to facilitate the supply of ventilators and personal protective equipment in Australia during the...