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Products clinical verification temporary provisions of medical equipment (1997-07)

Number of visits: Date:2006-12-29

" medical equipment register management method " enclose in " medical equipment register clinical experiment report divide into a regulation ", need to offer the report in making the clinical testing within the territory of China to any situations, any situations may offer the clinical experiment reports or external clinical laboratory reports of the like product in the past , have a regulation already. But to really needing when China do the clinical testing, how to carry on the clinical testing, which contents clinical experiment report should have , there is no regulation. Before the new regulation about clinical testing was not made , the method of the clinical testing still carries out " products clinical verification temporary provisions of medical equipment " of July of 1997 at present. For this reason, will is it log in on online , in order to help everybody consult again to stipulate we, but the content about 8th exemption in this regulation, yet suitable, because to which kind of situation is it make clinical for regulation to need in 16 order " medical equipment register clinical experiment report divide items of regulation ".
Products clinical verification temporary provisions of medical equipment
First, scope of application
The medical equipment should be tried out clinically before putting the market into. Try out and is divided into two ways of clinical research and clinical verification clinically. Clinical verification is suitable for some clinical mechanism being ripe, and has already had the standard of the products or the special-purpose medical equipment products that required safely in country (trade ).
Second, precondition of clinical verification
(1)Product this have products standard that accord with the regulations of " Standardization Act of the People 's Republic of China " already;
(2)the pattern of this product is tested and already finished, there is a qualified conclusion.
Third, clinical verification unit
Clinical verification should face sheet location go on in two prefecture-level city the above at least, generally determined by oneself according to the actual conditions by enterprises, the special circumstances are registered the responsible institution to appoint .
The clinical verification unit is not including participating in product development personnel 's unit.
Fourth, clinical verification personnel
The personnel who carry on clinical verification should have and prove technological rank of medical matters and qualifications and records of service that the medical equipment type is suitable for .
The personnel who carry on clinical verification have the right to ask for the materials related to clinical verification from the client of clinical verification, familiar with the use of the medical equipment , consult with client and propose the clinical verification scheme; In the course of clinical verification , there should be emergency measures , guarantee patient 's security.
The personnel who carry on clinical verification should notify side effect and accident situation appearing in clinical verification to the client and medical equipment administrative supervision administrative department .
Fifth, clinical verification scheme
(1)clinical verification scheme should be consulted with client of clinical verification to make by the personnel carrying on clinical verification.
(2)clinical verification scheme should include the following content :
1. Project content of clinical verification;
2. Participate in clinical verification personnel 's name , qualifications and records of service and hold a post in the department;
3. The overall design of clinical verification, should include such contents as the number , case , course of treatment , contrasting for a group of setting up and duration ,etc. ;
4. The appraisal method of the clinical performance result, evaluation criterion and counting the treatment method;
5. Measure that the side effect is predicted and should be taken in advance .
Sixth, the time limit and case of clinical verification count
Type of the products Verify time limit minimumly The least the quantity of case (each number , each hospital) Try out the quantity of the products at least Plant activly into the thing Half a year 3-20 3-20 There is no source to plant into the thing Half a year 5-20 5-20 Radiate and diagnose the apparatus 3 months 50 1-2 contraception apparatus 3 months and 30 1-2 other apparatus 3 the 30 2nd of months for 1000 1000 radiotherapy apparatus in one year
Seventh, clinical verification report
(1)clinical verification report should be signed by the personnel carrying on clinical verification, there are remarks of department (place , department , room ) that its hospital where one stays manages clinical verification that are stamped;
(2)content of the clinical verification report;
1. Prove client 's unit , name , and verify the apparatus name , specification type ;
2. Sex , age , dividing into groups to analyse of the number , total amount of cases and case that prove;
3. Contrast setting up and statistical method , appraisal method , evaluation criterion adopted of the group;
4. Data analysis of clinical verification;
5. Result analysis of clinical verification;
6. Clinical verification conclusion (include the scope of application , security , validity , dependability trouble of this apparatus and reprocess the situation , existing problem and improve proposing);
7. The explanation , analysis of side effect accident appearing improve the situation in clinical verification; 8. Report the term of validity for 2 years in clinical verification.
Eighth, exempt clinical verification
Some products that should carry on clinical verification , its producer can put forward and exempt clinical verification to apply according to situation and condition . It should generally accord with four following conditions at the same time to apply to exempt clinical verification:
1. Not the planting into medical equipment;
2. Not using supersound or the microwave , laser and X-ray , gal agate line, and other radioactive particles do the therapeutical equipment which treat the source ;
3. Register products and city is it prove safe effective products in structure principle , main function and index , use operational procedure ,etc. the same or similar already to sell;
4. Once products break down, does not can cause user or getting dead and wounded and great to injure the accident operator.
Ninth, regulation this as supplementary and perfection on " medical equipment products clinical to try out temporary provisions ", the demand about clinical clinical verification while trying out is carried out according to this regulation.

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