June 22, 2020
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
“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
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
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
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
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 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 21, 2020
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
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 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
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 […]