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Requisite data of Medical Device SFDA Registration
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(1) Application form.
(2) legal Qualification certification for medical device manufacturing enterprise.
(3) Document proving that the government in the country of origin has approved the product to be sold as medical device in the market of that country or region.
(4) Product technical specifictions which refer to the requirements for safety and technical functions of the product to be registered and the corresponding testing methods(two copies required for Class III products).
(5) Product instruction for use.
(6) Type test report issued within 1 year before the registration application by a test center recognized by the State Food and Drug Administration.(applicable to Class II and Class III products).
(7) Product clinic report.
(8) Product Quality Guarantee issued by the manufacturer certifying that the quality of the product to be registered for sale in China is exactly the same as that of the product marketed in the country (region) of origin.
(9) Letter of Authorization for designated agency.
(10) Letter of Authorization for designated after-sale service agency.
(11) Letter of Authorization for registration.
(12) Letter of Authorization for standard.
(13) Accord with national technology.
(14) Statement of quality responsibility.
(15) Truth and accuracy statement. |
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