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Regulations

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Regulations

Product Inspection Guide of Clinical Laboratory Reagents
1) The quantities of batch should meet the standard 3) Enough empty reagent bottles and reference samples for accurate experiment are needed if there are other package

Medical Electrical Equipment Testing Guide
5 Notes of diagnostic X-ray devices before testing:6 Notes of infrared light therapy devices before testing:Lists of critical component partsObjectManufacturer trademarkType m

Notes to delivery implants for surgery and related products
At present, our center could undertake kinds of implants for surgery including metallic bone plates, metallic bone screws, metallic intramedullary nailing systems, metal cor

The Guidance of Sample provision for biological test for manufactures
Test for systemic toxicityAcute systemic toxicity test1 Thickness

IVD Product Classification in China
(I) Class III products:2 Reagents related to blood group and tissue typing;4 Reagents related to inherited diseases;6 Reagents related to the inspection of targets sites

Required Form of Application Documents for Registration of In-Vitro Diagnostic Reagent at CFDA
IIThe contents of items in the application documents should be written in the first page All application documents should be made in the order specified in “Basic Requ

Initial registration for overseas medical devices that are approved for marketing at abroad issued by China CFDA
II Contents of licensing:Initial registration for overseas medical devices that are approved for marketing at abroad IV Fees:No chargeVI List of application documents:Data

Notice on overseas IVD registration issued by China CFDA
II Content of licensing:Overseas IVD registrationIV Fees:No chargeVI List of application documents:Data number (1) Overseas IVD registration application form;Data number (2)

Notice on renewal of registration for overseas IVD
II Content of licensing:renewal of registration for overseas IVDIV Fees:No chargeVI List of application documents:Data number (1) Overseas IVD registration application form;Data

Notice on alterations of Overseas IVD
II Content of licensing:Alterations of overseas IVD(I) Change of registration items:1 Change of manufacturer Name;2 Change of enterprise’s registered address;3 Change of

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