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2026 China NMPA Bluebook is here:
Manufacturers have long been concerned that when applying for drug-device combination product registration, in addition to original country approval for the combination product, the submission
The NMPA issued eleven Innovation Evaluation Reports for the 2nd Quarter of 2021, guiding overseas and domestic manufacturers on how to go through the fast-track
NMPA issued the final version of “2021 Medical Device Industry Standards Revisions Plan” on July 8, in which 77 medical devices and IVDs are affected.
NMPA issued the “Artificial Intelligence Medical Software Classification Guideline” on July 8, 2021, to direct manufacturers for the classification and the corresponding clinical data and
Our monthly NMPA News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVD in China, for the month
The NMPA granted four innovation review statuses on June 22, 2021, three innovation cardio devices which are cardiovascular-related and one for intraperitoneal surgery: Chengdu Sailanuo
On June 10, 2021, the NMPA issued the “Guideline of Shelf-life for Passive Implantable Medical Device”, directing type testing and regulatory submission for wide range
“Regulation on the Supervision and Administration of Medical Devices”, published in March 2021, mandates that “if the design, raw materials, production process, scope of application,
The Guangdong government published the “Interim Provisions on the Administration of Imported Medicines and Medical Devices in Urgent Clinical Needs in the Guangdong-Hong Kong-Macao Greater
Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. Policies China New
CMDE granted innovation and priority review status to four manufacturers in May, by which they can begin the fast-track application process. The complete list is
Unique Device Identification (UDI) will be implemented with all Class III devices, announced by NMPA at the “Notice on Applying Unique Device Identification System for