• 2020-06-11 09:36:28

A new online submission system has been implemented for one year, and NMPA notifies that the agents should renew the CA as soon as possible to ensure the certificate validity.

• 2020-05-12 06:20:32

On 2011, China NMPA published the 1st edition of “Guidance of Adverse Event Monitoring for Medical Device”. Now, they make a dramatic change on the adverse event system and modify the guidance according.

• 2020-05-12 06:08:27

NMPA of China released the registration work report in April 2020, covering the milestones of medical device regulations and registration applications from last year. In addition to actively improving relevant regulatory regulations and standards, NMPA also gradually adjusts its internal operating methods.

• 2020-04-14 08:57:04

NMPA has revised the quality inspection measure of medical devices to show their determination on strengthening post-market surveillance. The worst-case scenario manufacturers may face in PMS would be total product recall.

• 2020-04-14 08:54:35

Guiding manufacturers to develop medical devices which are safe and high performing, NMPA has released basic principles of investigation for all class of medical devices.

• 2020-04-14 08:47:59

In order to promote high-quality medical device industry, China is looking for ways to encourage domestic manufacturers to adopt higher technology and introduce incentives for foreign manufacturers with investments by local establishments.

• 2020-02-21 07:28:02

Due to the novel coronavirus pneumonia epidemic and its impact on China, the NMPA, local testing center and clinical sites have been given priority to emergency medical device approvals in epidemic situations. As a result, the progress of ordinary cases may be delayed

• 2020-02-21 07:23:38

Qualtech assisted in all registration stages, which included our service of planning the product pre-market strategy, conducting type testing, clinical trials, GCP inspection, medical writing, and the registration itself.

• 2020-02-21 07:12:37

On December 20, 2019, the NMPA issued an update of the Exemption List from Clinical Trials in China for Medical Device (hereinafter simply referred to as the “Exemption list"), which includes "medical devices" and "in vitro diagnostic devices".

• 2020-02-21 07:11:54

After publishing the guidance of clinical evaluation in the International Medical Device Regulators Forum (IMDRF), the NMPA has quickly released the revised guidance of clinical evaluation for China registration. This guidance is predicted to be implemented by 2021.