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Webinars

Part 4 Responsibilities And Potential Risks Of Medical Device License Holder In PMS.

2021-10-01

This session of the webinar introduces the the responsibilities and potential risks of medical device license holder in…

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Part 3 Medical Device Product Life Cycle Management With A Focus On Design Control

2021-10-01

This session of the webinar introduces the Medical device product life cycle management with a focus on design…

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Part 2 NMPA Medical Device QMS/GMP And Its Alignment With International Regulations Or Standards.

2021-10-01

This session of the webinar introduces the medical device QMS/GMP and its alignment with international regulations or standards.…

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Part 1 NMPA Medical Device Regulations/guidelines And Major Updates

2021-10-01

This session of the webinar introduces the medical device regulations/ guidelines and major updates. The speaker introduces the…

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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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Part 2 Major Changes To Clinical Evaluation Under Order 739

2021-10-01

This session of the webinar introduces major changes to clinical evaluation under order 739. it has some differences…

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Part 1 Order 739 Background

2021-10-01

This session of the webinar introduces medical device regulation milestones in China which is from 2014-2021. Then it…

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