Eleven Evaluation Reports from NMPA Reviewers: Roche and Sequent Medical on The List

NMPA issued eleven Innovation Evaluation Reports to 2^nd Quarter, 2021, guiding overseas and domestic manufacturers on how to go through the fast-track channel.

As NMPA standardizes and streamlines the review process for fast-track approvals, it is vital for manufacturers to comply with NMPA requirements if you have similar devices entering China market. The Evaluation Reports, ten-to-twenty-page long, describe the following aspects:

1. Pre-clinical Trial
   1. product performance research
   1. BC (biocompatibility)
   1. sterilization
   1. product expiration date and packaging
   1. animal study
   1. … …
2. Clinical Trial
   1. duration
   1. number of participants
   1. efficacy endpoints
   1. safety endpoints
   1. … …
3. Risk-benefit Analysis

Complete List

For an English copy of following NMPA Innovation Review Report listed above, please email us at ChinaMedDevice.com. We charge nominal fees for the translation.

1. Roche Diagnostics: Rabbit Anti-Human PD-L1/CD274 Monoclonal Antibody (Clone SP142)
2. Sequent Medical: Aneurysm Embolization System
3. Shenzhen Ruixin: Coronary CT blood flow reserve calculation software
4. Xiamen Zhishan: Fully Automatic Medical PCR Analysis System
5. Beijing Huifukang: peripheral nerve socket
6. Zhejiang Batai: Paclitaxel-eluting PTCA balloon dilatation catheter
7. Shenzhen xianjian: Temporary pacemaker
8. Baikangxin: Respiratory Pathogenic Bacteria Nucleic Acid Detection Kit
9. Tianjin Yingtai: Steep Pulse Therapy Apparatus
10. Shanghai MicroPort: Three-dimensional electronic abdominal endoscopy
11. Shanghai Xinchao Bio: Helicobacter pylori 23S rRNA gene mutation detection kit

How to Qualify the Innovation Pathway

The “Innovation Approval Procedure for Medical Devices” lists four criteria for domestic or imported Class II / Class III medical devices manufacturers to apply:

1. Provide significant clinical application value,
2. Own valid invention patent and have China Patent & Trade Office coverage,
3. Complete the preliminary study on a prototype with traceable data, and
4. Have an authorized in-country legal entity.

Click HERE to get an English copy of Innovation Device Approval Procedure, issued by NMPA in November 2018.

Source: https://chinameddevice.com/evaluation-reports/