What is New?

2018-02-02 CFDA Announcement on Releasing Good Manufacturing Practice for Medical Devices ([2014] No. 64)
2018-02-01 Will the Clinical Trial Condition Differences Affect the CFDA Oversea Clinical Trial Data Acceptance?
2018-01-25 How Will the Subjects Difference Affect the Oversea Clinical Trial Data Acceptance
2018-01-18 Technical Review Differences for The Oversea Clinical Trial Data Acceptance
2018-01-17 CFDA Issued Eight Registration Guidelines
2018-01-16 The Oversea Clinical Trial Data Submission Condition and Acceptance Requirements
2018-01-12 Accept the Medical Device Oversea Clinical Trial Data Technical Guideline
2018-01-11 CFDA Issued Six New Guidelines
2018-01-10 CFDA Clinical Trial Design Guideline
2017-12-26 CFDA Issued Four Registration Guidelines
2017-12-25 CFDA Issued Two Clinical Evaluation of Technical Review Guidelines
2017-12-19 CFDA Suspend The Import of Two Medical Devices in China
2017-12-18 CFDA  Issued Ten Registration Guidelines
2017-12-13 CFDA Medical Device Registration Administration Fee Standard (By 12/13/2017)
2017-12-12 Registration Declared Documents Requirements for Product Registration Alteration and Renewal
2017-12-11 CFDA Is About to Implement Medical Device Network Security Registration Technical Guidelines
2017-12-08 Clinical Assessment Requirements for the Clinical Trial Exampted Medical Devices
2017-12-07 CFDA Issued Administrative Measures for Medical Device Clinical Trial Institution Qualification and Filing
2017-12-01 CFDA Announced the 1st Oversea Medical Device Manufacturing Sites Inspection Results
2017-11-30 Understanding the Regulatory Framework and Procedure of Medical Device Clinical Trials in China
2017-11-29 CFDA Post-marketing Supervision-- Medical Device Quality Sampling (Nov-Jan, 2017)
2017-11-21 CFDA Issued Ten New Medical Device Registration Guidelines
2017-11-15 Will the Animal Test be Required for Your Medical Devices Before the Clinical Trials?
2017-11-15 CFDA Accept Medical Device Oversea Clinical Trial Data (Exposure Draft)
2017-11-13 Foreign Medical Device Applicants are Required to Supplement the Chinese Information to CFDA

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