Three fast-track channels have been established by NMPA to encourage innovation and deal with unmet medical needs: Innovation Approval, Priority Review, and Emergency Approval. For Priority Review, applicants for domestic
NMPA issued the “Optimizing Mandatory Standards for Medical Devices (Draft)” on January 5, 2022 for feedback. Feedbacks need to be submitted by February 10. The document lists 458 standards, many
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in December 2021. These updates are presented by China Med Device, LLC, your partner in
The NMPA published 34 guidelines in December 2021, involving provisions on clinical trials, same-variety comparison, and regulatory review for a wide range of indications. Significantly referred to many FDA guidance,
China Med Device, LLC joined the NMPA Session on interpreting the “Notice of Medical Device Submission Material Requirements and Certificate Format” held on December 16, 2021. The NMPA published the
NMPA published the “Evaluation of the Safety and Effectiveness of Medical Devices Containing Nanomaterials Part I: Framework” on August 30, 2021, directing manufacturers on key issues of nanomaterials’ registration. The
The NMPA held a conference in Beijing on December 27, 2021 to discuss the Real World Data program and better enhance the approval system for imported devices. Allergan’s Glaucoma treatment
The new “Regulation for Medical Device Administration and Supervision”, Order 739, effective since June 1, 2021, allows the implied permission for class III devices conducting clinical trial. It states that,
The NMPA released 19 industry standards on December 10, 2021, with indications ranging from cardiovascular, plastic surgery, oncology, clinical chemistry and immunology, etc. The standards revisions are to provide manufacturers
The NMPA released the “Communication Standards for Innovation Approval and Priority Review” on December 1, effective from the date of publication. The standards are to direct manufacturers on what to
The NMPA granted innovation approval to Suzhou LinaTech for the electron linear accelerator, and CMDE (Center for Medical Device Evaluaiton) issued the Review Report for the equipment. Indication and composition
NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostics” on December 3, 2021, finalizing the draft version issued in late November 2020. Clinical data generated outside
Email: info@chinameddevice.com
Phone: 978-390-4453
Office:
800 Turnpike St. Ste 300
North Andover, MA, 01845
