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 RegulationAdministrative Measures for Registration and Filing of In-vitro Diagnostic ReagentsCHAPTER 1 GeneralArticle 1This Measures is formulate
Chapter I General ProvisionsArticle 1 These Regulations are formulated for the purpose of ensuring the safety andeffectiveness of medical devices, safeguarding human health
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
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
Serial No Name of the productClassification codeProduct Description1Titanium plate with pulling loops6846The product consists of titanium plates, coils and sutures The titaniu
The Peoples Republic of ChinaMedical Device Registration Certificate (In-vitro Diagnostic Reagent)(Format)Review and Approval Department:Date of Approval: (Year) (Month) (Date)
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 Fees of Drug and Medical Device Product1 Drug registration feesThe food and drug supervision and administration department under managemen
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
