Year: 2020

NMPA published two Q&A on IVD equipment and hemodialyzer respectively, addressing two frequently asked issues: Q: When applying for an in vitro diagnostic equipment registration change, is it necessary to

NMPA issued fourteen guidelines in July. The guidelines cover indications of ophthalmic, orthopedic, gastroenterology and urology, anesthesia, and immunology, etc. Full List of Guidelines General Technical review guideline on modification

The unapproved devices can be clinically used in Hainan to collect real world data (RWD) and support its regulatory approval from NMPA. Under the policy, the scale-up usage and clinical

NMPA granted Fast-Track Status to two medical device manufacturers in July: Innovation approval status: Clinical Chemistry Shenzhen Guiji Chuangan: continuous glucose monitor Priority review status: Radiology Mingfeng Medical: X-ray computerized

NMPA published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 29, 2020 for feedback. It is an effort to implement risk-based clinical evaluation, and to

A Periodic Risk Evaluation Report (PRER) is required to submit to NMPA, depending on the initial NMPA registration time, according to Decree No. 1 Administrative Measures of Medical Device Adverse

In March 2018, the transformation from CFDA to NMPA, which emerged into State Administration for Market Regulation (SAMR), was to make the linkage between pre-market approval and post-market surveillance, to

NMPA published 14 guidelines in July 2020. The guidelines cover indications of ophthalmic, orthopedic, gastroenterology and urology, anesthesia and immunology, etc. Full List of Guidelines General Technical review guideline on

A Periodic Risk Evaluation Report is required to submit to NMPA, depending on the initial NMPA registration time, according to Decree No. 1 Administrative Measures of Medical Device Adverse Event

NMPA issued nine orthopedic standards on July 9, 2020 to guide manufacturers for local type testing and regulatory approval. Their implementation date is June 1, 2021. YY/T 1701-2020 Medical Ti-6Al-4V/Ti-6Al-4V

Here’s the June 2020 China NMPA regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese