What is New?

2019-10-21 The guidelines of the registration for the manufacture of passive implantable bone, joint and oral hard tissue
2019-10-11 Medical device unique identification (UDI) system rules were officially released
2019-09-24 CIRS Summary of attending CBIIC Conference in Suzhou on 23th September
2019-09-12 【Case Study】Infrared Thermal Imaging System Registration in China
2019-08-21 China Implements Electronic Application of Medical Device Registration
2019-08-07 CMDE Expands list of Medical Device Exempt from Clinical Trials
2019-07-30 How to Exempted from Clinical Trial for Medical Device Registration in China
2019-07-29 Division of Medical Device Registration Unit in China
2019-07-23 China issued medical device UDI pilot plan
2019-07-18 China Medical Device GxP Quality Systems
2019-07-08 New regulations for customized medical devices in China
2019-07-05 【Case Study】Blood Glucose Test Strip Registration in China
2019-06-25 【Case Study】Nasal Irrigator Registration in China
2019-06-21 【Case Study】Chemi-luminescence Immunoassay Analyzer Registration in China
2019-06-13 China’s State Council promulgated the Regulations on the Administration of Human Genetic Resources
2019-06-12 【Case Study】Medical Device Combined Package Registration in China
2019-06-10 NMPA released the 2018 medical device registration report
2019-05-31 Clinical research requirements for dressing products
2019-05-30 Meet CIRS in 58°Associazione Farmaceutici Industria (AFI)
2019-05-29 【Case Study】Mobile Medical Software Registration in China
2019-05-28 The Medical Device Supervision and Administration Regulations amended in 2019 may changes the product testing requirement
2019-05-24 NMPA indicates that the UDI system pilot work will begin soon
2019-05-23 Medical Device Electronic Regulated Product Submission System and Certificate Authority will start trial operation soon.
2019-05-22 Medical Device Supervision and Administration Regulations will be revised in 2019
2019-05-21 CIRS Released the Guideline on Market Access for Medical Device in China

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CIRS China

Mr. Harold Xie (Head office)
Tel: +86-571 8720 6559 | Fax: +86-571 87206533
Email: md@cirs-group.com
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Email: md@cirs-group.com

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Bryan Zhou
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Mr. Junho Lee 
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