• 2021-02-22 01:59:49

Recently, PFDA has shared two key guidance to the industry and stakeholders. FDAC 2020-001A updates the list of registrable medical devices while FDAC 2021-002 discusses the full implementation of medical device registration as per AO 2018-0002. The new guidance will have immediate impact the regulatory requirement for medical devices prior importing and selling in Philippines.

• 2021-02-22 01:36:27

The Indonesian Ministry of Health has stated that Vaccine and Pharmaceutical (medical) Storage / Refrigerator products are no longer considered medical devices locally. This is stipulated on an announcement on January 19, 2021. Therefore, Vaccine and Pharmaceutical (medical) Storage / Refrigerator can be freely sold in Indonesia without getting Medical Device Marketing Authorization Certificate from MoH.

• 2021-02-19 09:34:08

Recently, NMPA has added more devices into the second batch of medical devices exempt from clinical trials. Medical devices and in-vitro diagnostic reagents on the clinical trial exemption list won’t require completion of clinical trials in order to achieve NMPA certification.

• 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.

• 2021-01-19 02:48:31

• 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 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.

• 2020-12-23 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.

• 2020-12-23 01:53:56

To further develop a more practical and effective safety surveillance system, TFDA has set up regulations of serious adverse event reporting especially for medical devices. This article leads you into the main differences of the current and upcoming regulations.

• 2020-11-27 02:14:19

From October 19, 2020 to August 31, 2021, China will have a pilot run of electronic registration certificates issuance for medical devices. It will entail newly approved pre-market domestic Class III, foreign Class II and Class III medical devices.