June 22, 2020

NMPA Updates: Four Orthopedic Guidelines Published in One Day

NMPA issued four orthopedic guidelines on June 9, 2020 to guide manufacturers for local type testing and regulatory approval. Registration Guideline on 3D printed acetabular cup products Registration Guideline on […]
June 22, 2020

China Real World Data Adoption: Faster Introduction for Urgently Needed Devices

 “Regulations on the Management of Imported Medical Devices Urgently Needed in the Hainan Pioneer Zone” was published by Hainan government on June 2, 2020. This important document mandates the qualification […]
June 18, 2020

86 NMPA Standards to be Issued in 2020: Cosmetic Surgery, Cardiovascular and More

NMPA issued the finalized version of 2020 Medical Device Industry Standards Revision Plan on May 19, in which 86 medical devices and IVDs are affected. The Standards Revisions are aimed […]
June 12, 2020

NMPA News Roundup May 2020

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros from May 2020. These updates are presented by China Med Device, LLC, your partner […]
June 9, 2020

Feedback Needed for CDx Guideline by China NMPA

China’s Center for Medical Device Evaluation (CMDE), a division of NMPA announced its preparation of “Technical Review Guideline of Clinical Trial for Co-development of CDx Reagents and Anti-tumor Drugs” on […]
June 4, 2020

Record Number of Devices Obtain Innovation Status in May

NMPA granted innovative status to nine medical device manufacturers in May, including three foreign manufacturers and six domestic ones. Neurology Rapid Medical: Thrombectomy stent (Imported device) Keystone Heart: Anti-embolization distal […]
June 1, 2020

NMPA Guideline on Raw Material Changes for Non-active Devices: Eleven Examples

NMPA implemented the “Guideline on Raw Material Change Evaluation of Non-active Device” on May 19, 2020. The guideline has gone through modifications since the draft feedback was released on June […]
May 27, 2020
China periodic risk evaluation report

Periodic Risk Evaluation Report: China’s NMPA Further Specifies PMS Requirements

May 21, 2020

NMPA Approves the First Medical Device Through Real-World Data Program

Allergan’s Glaucoma treatment system became the first medical device obtained NMPA Approval through Real-World Data (RWD) program. The program, which has been piloted in Hainan since June 2019, was joined […]
May 11, 2020

NMPA News Roundup (April 2020)

Here’s April’s NMPA news affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to a colleague and opt-in here. For […]
May 8, 2020

NMPA to Down-Classify Certain Cancer Biomarker Reagents

NMPA will reclassify 29 cancer biomarker-related reagents from class III to class II with an announcement on April 24th, 2020. The impacted reagents include but not limited to the following: […]
May 7, 2020

China Enhancing Quality Inspection for Exported COVID-19 Medical Devices

Premier Li Keqiang of China, center, speaking at the Jinyintan hospital in Wuhan/ Reuters The Chinese government is moving to enhance quality inspection and export supervision for domestic COVID-19 related […]