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CFDA issued "Technical Guideline to accept Medical Device Overseas Clinical Data" on Jan.11, 2018.

The key information this Technical Guideline delivered are as follows:

1. Purpose

This guideline is to help applicant to prepare medical device overseas clinical data for CFDA registration, avoid or reduce repetitive clinical trials, to accelerate the premarket approval process in China

2. Scope

Medical Device (including IVD) that will register in China that could accept overseas clinical trial data as clinical evaluation documents for CFDA submission.

In this guideline, overseas clinical trial data means, in whole or in the same period at the qualified clinical trial organizations of host country, under the condition of normal use, the research data are generated from verification and validation of safety and effectiveness of medical device specified for CFDA registration.

The medical device in "Class III Medical Device Catalogue need Clinical Trial approval" could submit clinical trial data based on this guideline.

3. Guideline Constitution

Including 4 chapters, (1) Scope, (2) Basic Principal of accepting overseas clinical trial data, (3) Requirements of submit and accept overseas clinical trial data and (4) Consideration and technical requirements of accepting overseas clinical trial data documents.

4. Implementation

Overseas clinical trial should follow Ethics principles, law principles and scientific principles.

The documents that applicant should submit including: clinical trial Proposal, ethics opinions and clinical trial report, the clinical trial report should include the analysis and conclusion for complete clinical trial data.

Overseas clinical trials data should meet china registration requirements, if you are required to provide supplementary documents in CFDA review process, it is allowed to do supplementary clinical trial in China or abroad, the clinical trial data will be accepted if they meet china registration technical requirements.

If the applicant wants to submit the clinical trial documents based on multi-clinical trial centers data in China and abroad, the applicant should explain the allocation based on the number of cases in China, then CFDA will further assess if the data meet china registration requirements.

It is very important that the applicant has sufficient communication with CMDE reviewers before submitting overseas clinical trial data for success CFDA submission.

If you are interested in this Technical Guideline with more detailed information, please feel free to contact julianiu@ramed.top.

RAMED Biosciences provides Regulatory Affairs Service and Business Development for Medical Device and In Vitro Diagnosis for China.

CFDA issued "Technical Guideline to accept Medical Device Overseas Clinical Data" on Jan.11, 2018.

The key information this Technical Guideline delivered are as follows:

1. Purpose

This guideline is to help applicant to prepare medical device overseas clinical data for CFDA registration, avoid or reduce repetitive clinical trials, to accelerate the premarket approval process in China

2. Scope

Medical Device (including IVD) that will register in China that could accept overseas clinical trial data as clinical evaluation documents for CFDA submission.

In this guideline, overseas clinical trial data means, in whole or in the same period at the qualified clinical trial organizations of host country, under the condition of normal use, the research data are generated from verification and validation of safety and effectiveness of medical device specified for CFDA registration.

The medical device in "Class III Medical Device Catalogue need Clinical Trial approval" could submit clinical trial data based on this guideline.

3. Guideline Constitution

Including 4 chapters, (1) Scope, (2) Basic Principal of accepting overseas clinical trial data, (3) Requirements of submit and accept overseas clinical trial data and (4) Consideration and technical requirements of accepting overseas clinical trial data documents.

4. Implementation

Overseas clinical trial should follow Ethics principles, law principles and scientific principles.

The documents that applicant should submit including: clinical trial Proposal, ethics opinions and clinical trial report, the clinical trial report should include the analysis and conclusion for complete clinical trial data.

Overseas clinical trials data should meet china registration requirements, if you are required to provide supplementary documents in CFDA review process, it is allowed to do supplementary clinical trial in China or abroad, the clinical trial data will be accepted if they meet china registration technical requirements.

If the applicant wants to submit the clinical trial documents based on multi-clinical trial centers data in China and abroad, the applicant should explain the allocation based on the number of cases in China, then CFDA will further assess if the data meet china registration requirements.

It is very important that the applicant has sufficient communication with CMDE reviewers before submitting overseas clinical trial data for success CFDA submission.

If you are interested in this Technical Guideline with more detailed information, please feel free to contact julianiu@ramed.top.

RAMED Biosciences provides Regulatory Affairs Service and Business Development for Medical Device and In Vitro Diagnosis for China.

CFDA issued "Technical Guideline to accept Medical Device Overseas Clinical Data" on Jan.11, 2018.

The key information this Technical Guideline delivered are as follows:

1. Purpose

This guideline is to help applicant to prepare medical device overseas clinical data for CFDA registration, avoid or reduce repetitive clinical trials, to accelerate the premarket approval process in China

2. Scope

Medical Device (including IVD) that will register in China that could accept overseas clinical trial data as clinical evaluation documents for CFDA submission.

In this guideline, overseas clinical trial data means, in whole or in the same period at the qualified clinical trial organizations of host country, under the condition of normal use, the research data are generated from verification and validation of safety and effectiveness of medical device specified for CFDA registration.

The medical device in "Class III Medical Device Catalogue need Clinical Trial approval" could submit clinical trial data based on this guideline.

3. Guideline Constitution

Including 4 chapters, (1) Scope, (2) Basic Principal of accepting overseas clinical trial data, (3) Requirements of submit and accept overseas clinical trial data and (4) Consideration and technical requirements of accepting overseas clinical trial data documents.

4. Implementation

Overseas clinical trial should follow Ethics principles, law principles and scientific principles.

The documents that applicant should submit including: clinical trial Proposal, ethics opinions and clinical trial report, the clinical trial report should include the analysis and conclusion for complete clinical trial data.

Overseas clinical trials data should meet china registration requirements, if you are required to provide supplementary documents in CFDA review process, it is allowed to do supplementary clinical trial in China or abroad, the clinical trial data will be accepted if they meet china registration technical requirements.

If the applicant wants to submit the clinical trial documents based on multi-clinical trial centers data in China and abroad, the applicant should explain the allocation based on the number of cases in China, then CFDA will further assess if the data meet china registration requirements.

It is very important that the applicant has sufficient communication with CMDE reviewers before submitting overseas clinical trial data for success CFDA submission.

If you are interested in this Technical Guideline with more detailed information, please feel free to contact julianiu@ramed.top.

RAMED Biosciences provides Regulatory Affairs Service and Business Development for Medical Device and In Vitro Diagnosis for China.

CFDA issued "Technical Guideline to accept Medical Device Overseas Clinical Data" on Jan.11, 2018.

The key information this Technical Guideline delivered are as follows:

1. Purpose

This guideline is to help applicant to prepare medical device overseas clinical data for CFDA registration, avoid or reduce repetitive clinical trials, to accelerate the premarket approval process in China

2. Scope

Medical Device (including IVD) that will register in China that could accept overseas clinical trial data as clinical evaluation documents for CFDA submission.

In this guideline, overseas clinical trial data means, in whole or in the same period at the qualified clinical trial organizations of host country, under the condition of normal use, the research data are generated from verification and validation of safety and effectiveness of medical device specified for CFDA registration.

The medical device in "Class III Medical Device Catalogue need Clinical Trial approval" could submit clinical trial data based on this guideline.

3. Guideline Constitution

Including 4 chapters, (1) Scope, (2) Basic Principal of accepting overseas clinical trial data, (3) Requirements of submit and accept overseas clinical trial data and (4) Consideration and technical requirements of accepting overseas clinical trial data documents.

4. Implementation

Overseas clinical trial should follow Ethics principles, law principles and scientific principles.

The documents that applicant should submit including: clinical trial Proposal, ethics opinions and clinical trial report, the clinical trial report should include the analysis and conclusion for complete clinical trial data.

Overseas clinical trials data should meet china registration requirements, if you are required to provide supplementary documents in CFDA review process, it is allowed to do supplementary clinical trial in China or abroad, the clinical trial data will be accepted if they meet china registration technical requirements.

If the applicant wants to submit the clinical trial documents based on multi-clinical trial centers data in China and abroad, the applicant should explain the allocation based on the number of cases in China, then CFDA will further assess if the data meet china registration requirements.

It is very important that the applicant has sufficient communication with CMDE reviewers before submitting overseas clinical trial data for success CFDA submission.

If you are interested in this Technical Guideline with more detailed information, please feel free to contact julianiu@ramed.top.

RAMED Biosciences provides Regulatory Affairs Service and Business Development for Medical Device and In Vitro Diagnosis for China.

CFDA issued "Technical Guideline to accept Medical Device Overseas Clinical Data" on Jan.11, 2018.

The key information this Technical Guideline delivered are as follows:

1. Purpose

This guideline is to help applicant to prepare medical device overseas clinical data for CFDA registration, avoid or reduce repetitive clinical trials, to accelerate the premarket approval process in China

2. Scope

Medical Device (including IVD) that will register in China that could accept overseas clinical trial data as clinical evaluation documents for CFDA submission.

In this guideline, overseas clinical trial data means, in whole or in the same period at the qualified clinical trial organizations of host country, under the condition of normal use, the research data are generated from verification and validation of safety and effectiveness of medical device specified for CFDA registration.

The medical device in "Class III Medical Device Catalogue need Clinical Trial approval" could submit clinical trial data based on this guideline.

3. Guideline Constitution

Including 4 chapters, (1) Scope, (2) Basic Principal of accepting overseas clinical trial data, (3) Requirements of submit and accept overseas clinical trial data and (4) Consideration and technical requirements of accepting overseas clinical trial data documents.

4. Implementation

Overseas clinical trial should follow Ethics principles, law principles and scientific principles.

The documents that applicant should submit including: clinical trial Proposal, ethics opinions and clinical trial report, the clinical trial report should include the analysis and conclusion for complete clinical trial data.

Overseas clinical trials data should meet china registration requirements, if you are required to provide supplementary documents in CFDA review process, it is allowed to do supplementary clinical trial in China or abroad, the clinical trial data will be accepted if they meet china registration technical requirements.

If the applicant wants to submit the clinical trial documents based on multi-clinical trial centers data in China and abroad, the applicant should explain the allocation based on the number of cases in China, then CFDA will further assess if the data meet china registration requirements.

It is very important that the applicant has sufficient communication with CMDE reviewers before submitting overseas clinical trial data for success CFDA submission.

If you are interested in this Technical Guideline with more detailed information, please feel free to contact julianiu@ramed.top.

RAMED Biosciences provides Regulatory Affairs Service and Business Development for Medical Device and In Vitro Diagnosis for China.