While applying for MD product initial registration of Class II and Class
III, clinical trial information has to be submitted. The drug regulatory
authorities of provinces, autonomous regions and municipalities directly
under the central government are responsible for the inspection and approval
of the clinical trial of class II medical devices in their own
administrative regions. The State Food and Drug Administration is
responsible for the inspection and approval of clinical trial of class III
medical devices.
Clinical trial shall be conducted in the medical institutions designated by
the drug regulatory authorities of the government at provincial level and
above. The medical institutions shall conduct the clinical trial, in
accordance with SFDA Oder 5 "Provisions for Clinical Trials of Medical
Devices" taken go into effect as of April 1, 2004. The qualification of
medical institutions engaged in the clinical trial shall be certified by the
drug regulatory authority, jointly with Ministry of Health.
Based on the different condition that whether it has been already placed
into market overseas or this enterprise or applicant has already registered
equivalent products in China, the detail requirements of clinical trial
information are different and clarified in annex 12 of SFDA order 16
"Provision for Medical Devices Registration" taken into effect as of August
9, 2004.
If the clinical trial of medical devices conducts in China, the information
provided in clinical trial report includes contracts, protocols, and the
final summarized reports. Whenever necessary, SFDA may require the applicant
to submit the Notice, Informed Consent and original test records.
Based on the above requirements of MD clinical trials, clinical trials of
IVD reagents specifies the detail requirements in SFDA Notice [2007]229
"Management Method of In Vitro Diagnostic Reagents Registration (Interim)"
taken effect as of June 1, 2007. The details contain the quality of detected
product, detection unit and specifications, the qualification and quantity
of clinical trial institution and the minimum quantity of specimens.
Moreover the detail technical requirements of basic principle, research
method, specimen volume and the establishment of clinical research report
are clarified in "Technical Guideline Clinical Research for IVD Reagent"
implemented on the same day.
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