Regulatory Open Forum

China State Council released the "Guideline on further Reform of Regulatory Review and Approval for Drugs and Medical Device" on Oct.8, 2017, this new Reform Policy will have significant changes in Chinese Pharma and medical devices market, I would like to share the following 4 key impacts from Medical Device and IVD perspectives for your reference.

1. Innovate Clinical Trial Management. CFDA will collaborate with National Healthcare and Family Planning Commission(NHFPC) to release more detailed information on how to establish Medical Device Clinical Trial Organization and Clinical Trial Projects Management System instead of registration based before. Allowing Extended Clinical Trial and the related Clinical Data could be used for Registration Application. The deliberate act of altering, omitting Clinical Data will be illegal and will get serious punishment.

2. Accelerate CFDA Review and Approval. CFDA will accept overseas' Clinical Trial Data, the global CRO companies and Clinical Research Sites will have more opportunities to provide services to compensate the shortage of clinical research sites in China.

3. Improve CFDA Review and Approval System. Push Panel review format and improve the communication mechanism between the Applicants and CMDE, execute Expert Consulting Commission Mechanism for Significant technical issues. Domestic Class II medical device will be reviewed by criteria step by step and finally move to CFDA instead of Provincial level CFDA review currently.

4. Implement Medical Device "whole Life Cycle Management".  Medical Device will adopt Marketing Authorization Holder(MAH) mechanism from Development, Clinical Trial, Manufacturing, Distribution, Recall, Adverse Events and Re-Evaluation. MAH will be responsible for all these activities. 

In general, Innovation is the key topic for this new guideline and Chinese government will encourage all the related parties to accelerate the medical reform and healthy rapid development.

If you are interested in this topic, please feel free to contact me at julianiu@ramed.top for more detailed information.

China State Council released the "Guideline on further Reform of Regulatory Review and Approval for Drugs and Medical Device" on Oct.8, 2017, this new Reform Policy will have significant changes in Chinese Pharma and medical devices market, I would like to share the following 4 key impacts from Medical Device and IVD perspectives for your reference.

1. Innovate Clinical Trial Management. CFDA will collaborate with National Healthcare and Family Planning Commission(NHFPC) to release more detailed information on how to establish Medical Device Clinical Trial Organization and Clinical Trial Projects Management System instead of registration based before. Allowing Extended Clinical Trial and the related Clinical Data could be used for Registration Application. The deliberate act of altering, omitting Clinical Data will be illegal and will get serious punishment.

2. Accelerate CFDA Review and Approval. CFDA will accept overseas' Clinical Trial Data, the global CRO companies and Clinical Research Sites will have more opportunities to provide services to compensate the shortage of clinical research sites in China.

3. Improve CFDA Review and Approval System. Push Panel review format and improve the communication mechanism between the Applicants and CMDE, execute Expert Consulting Commission Mechanism for Significant technical issues. Domestic Class II medical device will be reviewed by criteria step by step and finally move to CFDA instead of Provincial level CFDA review currently.

4. Implement Medical Device "whole Life Cycle Management".  Medical Device will adopt Marketing Authorization Holder(MAH) mechanism from Development, Clinical Trial, Manufacturing, Distribution, Recall, Adverse Events and Re-Evaluation. MAH will be responsible for all these activities. 

In general, Innovation is the key topic for this new guideline and Chinese government will encourage all the related parties to accelerate the medical reform and healthy rapid development.

If you are interested in this topic, please feel free to contact me at julianiu@ramed.top for more detailed information.