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Clinical Evaluation

Medical Device Real World Evidence (RWE) In China: Policies, Usage, Study Plan, Case Study

2022-06-23

Part 1: Overview of policies, regulations, and guidelines of RWE in China Firstly, the speaker uses a graph…

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Part 5 Major Differences Between A China CER And An EU CER

2022-03-01

The speaker use a table to show major differences between a China CER and an EU CER.

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Part 4 Good Practice As Well As Pitfalls In Preparing A China CER

2022-03-01

There is a common review inquires for CER via Equivalence, for example, it list the following ppoints: study…

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Part 3 How To Prepare A Convincing China CER

2022-03-01

The speaker draw a outline CER outline to clarify how to prepare a convincing China CER. Then, it…

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Part 2 Have You Chosen The Best Clinical Pathway To Register Your Products In China?

2022-03-01

The speaker use a diagram to illustrate the clinical pathway under order 680. Then, it talks about least…

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Part 1 Major Changes To Clinical Evaluation Under Order 739

2022-03-01

The speaker talks about the changes under order 739 which is clinical evaluation for the whole life cycle.…

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Part 8 Takeaways

2021-10-01

This session of the webinar introduces takeaways. The speaker labeled in following points: clinical evaluation shall be conducted…

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Part 7 Other Updates Relevant To Clinical Evaluation

2021-10-01

This session of the webinar introduces other updates relevant to clinical evaluation. The speaker talk about the technical…

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Part 6 Major Differences Between China CER And MDR CER

2021-10-01

This session of the webinar introduces major differences between China CER and MDR CER. The speaker use table…

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Part 5 How To Write A China CER Under The New Regulation

2021-10-01

This session of the webinar introduces how to write a China CER under the new regulation. Firstly, the…

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Part 4 When Can You Submit A CER In Lieu Of A CSR

2021-10-01

This session of the webinar introduces when can you submit a CER in lieu of a CSR. Firstly,…

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Part 3 Are Your Devices Clinical Exempted

2021-10-01

This session of the webinar introduces medical device exempted from clinical trail. It explains some exemption criteria, consolidated…

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