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The State Administration for Market Regulation (SAMR) issued the “Measures for the Supervision and Administration of Cosmetics Production and Operation” on August 2, 2021. The Measures will come into effect
The NMPA Standards Management Center published the “First Batch of Combination Products Classification Results in 2021” on July 7. Worth noted that overseas manufacturers pay more attention to the combination
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 of certificates of the drug,
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 channel. As the NMPA standardizes
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. The Standards Revisions are aimed
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 regulatory submission. It is the
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 of June 2021. Policies Self-Test
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 Medical: Endovascular Aortic Stenosis System
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 of non-active implantable devices. Batch-to-Batch
“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, method of use, etc. of
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 Bay Area (draft)” on June
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 GCP Announced NMPA published “Medical