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Regulations

State Administration for Market Regulation Decree No. 47

State Administration for Market RegulationDecree No 47Administrative Measures for the Registration and Filing of Medical DevicesCHAPTER 1 GeneralArticle 1The Measures is esta
State Administration for Market Regulation Decree No. 48

State Administration for Market RegulationAdministrative Measures for Registration and Filing of In-vitro Diagnostic ReagentsCHAPTER 1 GeneralArticle 1This Measures is formulate
Regulations on the Supervision and Administration of Medical Devices

Chapter I General ProvisionsArticle 1 These Regulations are formulated for the purpose of ensuring the safety andeffectiveness of medical devices, safeguarding human health
Decree of the State Council of the People's Republic of China No. 680

The Decisions on the Amendment of the Rules on Supervision and Administration of Medical Devices by the State Council are hereby promulgated and come into effect since the date of promulgation
List of Class II Medical Devices exempted from Clinical Trial (3rd Batch) (Draft for comments)

Serial No Name of the productClassification codeProduct Description1This product is usually an assembly of a main body, a base, O-rings and a rubber cap Only the main bo
List of Class III Medical Devices exempted from Clinical Trials (3rd batch) (Draft for comments)

Serial No Name of the productClassification codeProduct Description1Titanium plate with pulling loops6846The product consists of titanium plates, coils and sutures The titaniu
CFDA Notification #44 Requirements and Instructions for the Registration Application Documents of IVD Reagent

The Peoples Republic of ChinaMedical Device Registration Certificate (In-vitro Diagnostic Reagent)(Format)Review and Approval Department:Date of Approval: (Year) (Month) (Date)
CFDA Notification #43 Requirements and Instructions for Medical Device Registration Application

Approved by (Department):Date of Approval: YYYY MM DDDate of Expiry: YYYY MM DD(Seal of Evaluation and Approval Department)Appendix 2Permission of change to registration for me
Charging standard for registration fee of Drug and Medical device (IVD same as MD)

Charging Standard for Registration Fees of Drug and Medical Device Product1 Drug registration feesThe food and drug supervision and administration department under managemen
Instructions to Reagent Submission and Test

3 Submission Requirements of the Standard DataThe following materials are needed for the third kind of scale:2 Product instruction;4 Analysis of the data for performance ev
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