• 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.

• 2021-06-25 13:10:29

China's Regulations on the Supervision and Administration of Medical Devices have undergone a series of changes recently. In this article, let's take a look at these changes and how you can prepare to implement them in your medical devices in the China market.

• 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.

• 2021-04-26 02:33:36

On December 21, 2020, State Council in China announced the adoption of New Regulations on the Supervision and Administration of Medical Devices (Medical Devices Order. 739 of the State Council). Respectively on March 18, 2021, State Drug Administration officially issued the revised Regulations on the Supervision and Administration of Medical Devices, corresponding with a set of Draft Measures.

• 2021-03-22 01:58:21

On February 25th, Qualtech organized a webinar and guided participants through the China medical device regulations. Our expert covered such topics as registration preparation, registration reviewing process, post-market process.

• 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.

• 2021-02-19 08:45:21

NMPA has introduced important adjustments to the contents of the Classification Catalogue of Medical Devices for 28 classifications of medical devices, including management of 15 classifications of medical devices and catalogue contents of 13 classifications of medical devices.

• 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 02:48:31