• 2021-02-19 08:35:07

Starting from January 1, 2021, medical devices specially identified by the NMPA should register in the eRPS system, along with UDI-DI related information.

• 2021-01-19 02:59:53

Hong Kong boasts a wealthy and sophisticated medical device market. With the medical technology industry being one of the major driving forces for the country’s booming economy, in this edition of QT Analysis, we delve deep into the reasons why it is a booming medical device market in Asia and how you shouldn’t miss out on the great business opportunities it offers.

• 2021-01-20 01:20:07

Starting 25th August 2020, TGA has adopted new medical device definition and a number of other related definitions in the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations), as well as minor amendments to the requirements for system or procedure packs in the Regulations.

• 2021-01-19 02:48:31

A new policy initiative recently agreed between the Hong Kong and China Mainland governments proposes to allow Hong Kong-listed medical devices and drugs to be sold to Hong Kong-owned medical institutions within the Greater Bay Area without prior NMPA registration.

• 2021-01-19 02:38:54

NMPA's newly released Guiding Principles explain the general, principled and forward-looking requirements for the application of real-world data of medical devices in clinical evaluation.

• 2020-12-24 11:02:25

Thai FDA is committed to ensuring utmost standard, quality and safety of medical devices marketed in Thailand is consistently kept. Hence, they have announced a new medical device complaint channel, complaint record and management system for inspection. This decree is beneficial in providing assurance to consumer regarding safety and prevention of comparable adverse event in the future.

• 2020-12-24 10:54:11

Thai FDA has recently announced a list of standards to be complied by disposable surgical masks, upon making a set of COVID-19 related medical devices announcement.

• 2020-12-24 02:53:02

A person who wishes to advertise a medical device in Thailand must obtain a medical device advertising license upon any medical devices marketing activity. Thai FDA had published further advertising announcement regarding the advertising specifications of medical devices that are exempted to proceed advertising license registration to conveniently advertise medical devices.

• 2020-12-24 01:55:33

Ministry of Public Health has introduced a new guidance document regarding labelling of medical devices to be registered and sold in Thailand. This is to ensure consumers safety, as well as distributing accurate and sufficient medical device information.

• 2020-12-23 07:07:34

The Vietnam Ministry of Health has issued Circular No. 14/2020/TT-BYT dated 10 July 2020 (“Circular No. 14“), which regulates various aspects of the bidding process of medical devices for public health establishments. This circular took effect on 1 September 2020.