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Webinars

Part 2 Measures For Supervision And Adminstration Of Medical Device Production (China GMP) And Key Aspects Of Onsite Inspections.

2022-01-21

To better understanding China GMP, the speaker used a tablle to list corresponding main items for ISO 13485:2016).…

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Part 1 Introduction The Webinar——Keep Up With The Enhancement Of Medical Device Post-Market Surveillance In China: GMP, GSP, And NMPA Onsite Inspections

2022-01-21

Introduction to the regulations The speaker introduces the development of of medical device regulations in China which are…

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Part 7 Stricter Post-market Surveillance Requirements And MAH’s Responsibilities Under Order 739

2021-11-23

This session of the webinar introduces the Stricter post-market surveillance requirements and MAH’s responsibilities under order 739. In…

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Part 6 Comparing CER Draft Vs Final Guidance

2021-11-23

This session of the webinar briefly compares CER draft vs final guidance. The speaker use a table to…

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Part 5 Major Changes To Clinical Evaluation Under Order 739

2021-11-23

This session of the webinar introduces the major changes to clinical evaluation under order 739. The speaker review…

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Part 4 Major Changes To Renewal & Modification Under Order 739

2021-11-23

This session of the webinar introduces the major changes to renewal & modification under order 739. The speaker…

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Part 3 Major Changes To Type Testing Under Order 739

2021-11-23

This session of the webinar introduces the major changes to to type testing under order 739. The speaker…

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Part 2 Major Changes To Registration Dossier Under Order 739

2021-11-23

This session of the webinar introduces the major changes to registration dossier under 739. The speaker shows a…

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Part 1 Revisiting Order 739

2021-11-23

This session of the webinar introduces the background of order 739. The speaker introduces the hierarchy of NMPA…

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Part 7 Draft And Submit Periodic Risk Evaluate Report (PREP) To China NMPA

2021-10-01

This session of the webinar introduces the draft and submit periodic risk evaluate report (PRER) to China NMPA.…

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Part 6 Adverse Event Reporting Management Under Order 739

2021-10-01

This session of the webinar introduces the adverse event reporting management under order 739. The speaker list article…

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Part 5 How To Choose Distributors Who Are Compliant With NMPA Requirements In China?

2021-10-01

This session of the webinar introduces how to choose distributors who are compliant with NMPA requirements in China.…

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