• 2021-10-27 05:29:58

The “Administrative Measures for the Registration and Filing of Medical Devices” have been adopted at the 11th executive meeting of the State Administration for Market Regulation on July 22, 2021. The measures have subsequently been promulgated and have come into effect on October 1, 2021 via Decree No. 47.

• 2021-09-30 07:43:02

On July 22, 2021, the China State Administration for Market Regulation has released a new version of the "Administrative Measures for the Registration and Filing of Medical Devices", which will be executed and come into effect on October 1, 2021.

• 2021-08-01 15:44:44

CMDE has added one more step to confirm the information shown on the medical device registration certificate and its attachments in the process of technical review from June 7, 2021.

• 2021-08-01 15:11:37

Recently, NMPA issued has issued a draft Regulation on self-testing for medical device registration. It has been published for public comments.

• 2021-06-25 08:59:13

Qualtech Consulting would like to invite you to our free online Webinar on the subject of the ”China Medical Device Registration – New Regulation for Supervision and Administration of MDs (RSAMD)”, which has gone into effect on June 1, 2021.

• 2021-05-22 06:49:37

Recently, NMPA issued a Notice on Registration of Medical Device Technical Dossier (No. 36 of 2021), which will facilitate medical device manufacturers to choose raw materials and key components, simplify registration declaration, improve the quality of medical device review and approval, establish a more scientific and efficient review and approval system, and encourage innovation.

• 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.