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CFDA issues 6 documents including the template for application and review form for ethical review of clinical trials of medical devices (No. 58, 2016)2016-03-29

CFDA issues Good clinical practice for medical devices (No. 25, 2016)2016-03-29

In March 23th, 2016, Good clinical practice for medical devices is issued by CFDA and National Health and Family Planning Commission and will be implemented from June 1st, 2016, to replace current regulations on clinical

CFDA Announcement Regarding the Issue of Charging Standards for the Registration of Drugs and Medical Devices (No. 53, 2015)2015-05-28

On May 27, 2015, CFDA released announcement regarding the issue of charging standards for the registration of drugs and medical devices (No. 53, 2015)

CFDA issues Measures for the Administration of Medical Device(including IVD Reagents) for Renewal2015-05-27

On March, 2015, CFDA released measures for relevant issues of documents for renewal.

CFDA issues Measures for the Administration of IVD Reagents2014-09-29

On June 27, 2014, CFDA released the Measures for the Administration of IVD Reagents, coming into force from October 1, 2014.

CFDA issues Measures for the Administration of Medical Device Registration2014-09-30

On June 27, 2014, CFDA released the Measures for the Administration of Medical Device Registration, coming into force from October 1, 2014.

CFDA announces issues about Class I MD filing2014-09-30

On May 30, 2014, CFDA issued an announcement where detailed regulation on Class I MD filing is specified.

CFDA issues guidelines for compiling MD product technical requirements2014-09-30

On May 30, 2014, CFDA issued new guidelines on MD product technical requirements, where normative requirements are made for the form and content of product technical requirements.

CFDA issues Class I MD directory2014-09-30

On May 30, 2014, CFDA issued Class I MD directory, to reorganize class I MD listed in 2002 MD catalogue and other related classification documents, where more details and additional information is provided.

CFDA announces issues about execution of MD Regulations2014-09-30

On May 23, 2014, CFDA made an announcement, to clarify administrative measures before regulations and normative documents to go with Regulations for the Supervision and Administration of Medical Devices come out.

QME tips in response to the storm of CFDA inspection2016-07-29

FDA Proposes Ban on Powdered Gloves after Years of Review2016-07-29