
How to Classify a Device? NMPA Guidance Reveals
The NMPA issued the “Guidance on Application Materials for Classification of Medical Devices” on June 14, 2023. It is applicable to both domestic and overseas
Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:

The NMPA issued the “Guidance on Application Materials for Classification of Medical Devices” on June 14, 2023. It is applicable to both domestic and overseas

On May 16, 2023, the NMPA granted innovation approval to Corindus Inc., for its interventional coronary surgical control system accessories. It is the fifth imported

China’s Ministry of Science and Technology published the “Details for the Implementation of the Human Genetic Resources Regulations” on June 1, 2023. Based on “Human

The NMPA issued the “Draft Guideline on Modification Registration IVD of In Vitro Diagnostic Reagent” on May 31, 2023, for feedback. Feedbacks need to be

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in May 2023. These updates are presented by China

The NMPA issued “Guideline on Recombinant Humanized Collagen Raw Materials” and “Guideline on Recombinant Collagen Wound Dressings” on May 23, 2023. The two guidelines are

The NMPA issued the final document of “2023 Medical Device Industry Standards Revisions Plan” on May 24, two weeks after the release of draft version.

China’s NMPA issued a notice titled “Information Collection from Enterprises and Institutions Related to the Preparation of the Guideline for Intracranial Coils and Guideline for

On May 16, 2023, the NMPA granted innovation approval to Conavi Medical Inc., from Canada, for its intravascular imaging system. It is the fourth imported

The NMPA issued the draft version of “2023 Medical Device Industry Standards Revisions Plan” on May 12, 2023, with the deadline for feedbacks on May

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in April 2023. These updates are presented by China

The NMPA granted innovation approvals to seven devices in April 2023, for indications ranging from cardiovascular, orthopedic, neurology and ophthalmic. Among them are two imported