No 4 Provisions for Medical Device RegistrationWord文档下载推荐.docx

1、Article 3Medical device registration refers to approval process conducted by the food and drug regulatory authority upon an application submitted by the registration applicant, follows the legal procedure to decide whether the medical device to be marked can be approved or not based on a comprehensi

2、ve assessment on research and its result of medical devices safety and effectiveness.Medical device filing refers to the food and drug regulatory authority files filing materials submitted by the filing applicant for future reference.Article 4Registration and filing shall follow the principle of pub

3、licity, justice, and equity. Article 5 Filing administration shall be implemented for Class I medical devices. Registration administration shall be implemented for Class II and Class III medical devices.Filing for Class I domestic medical device, the filing applicant shall submit the filing to the f

4、ood and drug regulatory authority of the municipality consisting of districts.Class II domestic medical devices shall be inspected by the food and drug regulatory authority of the provinces, autonomous regions, municipalities directly under the central government, and the Registration Certificate fo

5、r Medical Device will be granted after approval.Class III domestic medical devices shall be inspected by the China Food and Drug Administration （hereinafter referred to as CFDA）, and the Registration Certificate for Medical Device will be granted after approval.Filing for Class I imported medical de

6、vice, the filing applicant shall submit the filing to CFDA.Class II and Class III imported medical devices shall be inspected by the CFDA, and the Registration Certificate for Medical Device will be granted after approval.The medical devices from Hong Kong, Macau and Taiwan shall be registered or fi

7、led refer to the imported medical devices.Article 6The registration applicant and filing applicant shall launch product to the market in its own name and hold legal liability for the product.Article 7The food and drug regulatory authority shall publicize information of medical device registration an

8、d filing according to the regulations. The applicant can inquiry the approval process and results, the public can look up approval results.Article 8China encourages research and development and innovation of medical devices, conducts special approval procedures for innovative medical devices, contri

9、butes to promotion and application for new technology of medical devices and boosts the development of medical device industry. Chapter II Basic RequirementArticle 9 The applicant or the filing applicant shall establish quality management system related to R&D and manufacture of product, implement i

10、t and keep it operates effectively. For domestic products approved by the special approval procedures for innovative medical device apply for the registration application and samples entrusted other manufacturers to produce, the entrusted manufacturers shall have corresponding manufacturing scope; f

11、or domestic products not approved by the special approval procedures for innovative medical device apply for registration application, their samples cannot entrust other manufacturers to produce.Article 10 The person that apply for registration or conduct filing for medical device shall have the cor

12、responding professional knowledge and be familiar with laws, regulations, normative documents and technical requirements regarding to medical device registration or filing administration.Article 11The applicants or the filing applicants shall follow the basic requirement for safety and effectiveness

13、 of medical device, ensure R&D process are being truthful and standardized , and all the data is true, complete and traceable when they conduct filing or apply for registration. Article 12The materials for registration application shall use Chinese. When the application documents are translated from

14、 a foreign language, the original documents shall also be provided at the same time. When referring to unpublished literature, the applicant shall provide evidence of owners permission to use the information.The applicant shall take fully responsibility for the authenticity of the registration appli

15、cation documents.Article 13 For imported medical device intended to apply for registration or conduct filing, the applicant or the filing applicant shall get market clearance of the country or region where their registration or manufacturing place located for the medical device.If country or region

16、where the applicants or the filing applicants registration or manufacturing places located does not administer the products as medical device, the applicant or the filing applicant shall provide relevant supporting documents, including the approval of legal sales issued by the country or region wher

17、e their registration or manufacturing place located.Article 14 The overseas applicant or the filing applicant shall conduct relevant business through their representative office located within the territory of China or designate an enterprise located within the territory of China as agent.Besides co

18、nduct registration and filing related work, the agent shall be liable for:（1） Contact with corresponding food and drug regulatory authority and the overseas applicant or the filing applicant; （2） Deliver related laws, regulations and technical requirement to the applicant or the filing applicant tru

19、ly and faithfully;（3） Collect post-market adverse event information of medical devices and feed back to the overseas applicant or the filing applicant , meanwhile, report to relevant food and drug regulatory authority;（4） Collaborate the recall for post-market medical devices, and report to relevant

20、 food and drug regulatory authority;（5） Undertake other joint liabilities related to product quality and after-sales service. Chapter III Product technical requirement and Registration TestingArticle 15 The applicant or the filing applicant shall prepare the product technical requirement of the medi

21、cal device to be registered or filed. The product technical requirement of Class I medical device shall be submitted to the food and drug authorities during the applicant conducts filing. The product technical requirement of Class II or Class III medical devices shall be checked and approved by the

22、food and drug authorities at the time of registration approval.The product technical requirement mainly includes the performance indices and testing method of the completed medical device, and the performance indices refer to the objective determination of product functionality, security index and o

23、ther indicators of quality control.The medical device launched in China shall comply with its product technical requirement which was checked and approved for registration or filed already.Article 16The registration testing shall be conducted to apply registration for Class II and Class III medical

24、device. The testing institutes of medical device shall conduct registration testing according to product technical requirement. The manufacture of samples for registration testing shall comply with related requirements of quality management system; products tested to be qualified in registration tes

25、ting can be used for clinical trial or registration application. The filing applicant can submit self-testing report of the product to conduct filing.Article 17To apply for registration testing, the applicant shall provide samples, product technical requirement and other technical materials required

26、 by the registration testing to the testing institutes.Article 18Testing institutes of medical device shall have certain qualifications, perform testing within their specified testing scope and conduct pre-evaluation on the product technical requirement. The testing institutes shall issue the pre-ev

27、aluation opinions and the registration testing report of medical device together to the applicant. For the medical devices that have not been included in testing scope of any medical device testing institutes, the related registration authority shall designate a capable testing institute to conduct

28、the testing.Article 19 The testing products in a same registration unit shall represent the safety and effectiveness of the rest products in this registration unit. Chapter IV Clinical EvaluationArticle 20 Clinical evaluation of medical device refers to the process that the applicant or the filing a

29、pplicant validates whether a product can meet the operating requirements or scope of application or not through clinical literature, clinical practice data, clinical trial and other information.Article 21Clinical evaluation materials refer to the documents formed by the applicant or the filing appli

30、cant during the clinical evaluation.For those required clinical trial, the clinical evaluation materials to be submitted shall include the protocol and the report of clinical trial.Article 22It is not necessary to conduct clinical trial for filing Class I medical devices. It is necessary to conduct clinical trial for registration application of Class II and Class III medical devices; however, in any of the following circumstances, the clinical trial could be exempted.（1） With definite operating principle, established design, mature manufacture process; no record