Register for Upcoming Webinar on DEC. 8 @ 11AM
2025 China NMPA Bluebook is here:
Allurion’s weight loss gastric balloon completed the first implantation in China at Hainan Ruijin Hospital on June 27, 2023. Overweight patients with a body mass index (BMI) greater than 27
The NMPA granted innovation approvals to two devices on June 20, 2023. There have been 217 innovation devices approved since 2014. To get an English copy of innovation devices catalog,
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 manufacturers. Application Pathway Applicants log
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 innovative device approved by the
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 Genetic Resources Management Regulations” effective
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 submitted by June 30, 2023.
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 Med Device, LLC, your partner
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 final versions after the drafts
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. 15 mandatory and 102 recommended
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 Stent Retrievers” on May 17,
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 innovative device approved by the
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 19. The plan proposes 15