Medical device filing regulations?
Chapter I General Provisions
Article 1 In order to ensure the safety and efficacy of medical devices, to protect human health and life safety, the formulation of these regulations.
The second in the Chinese people *** and the State engaged in the development of medical devices, production, operation, use of activities and their supervision and management shall comply with these regulations.
The third state council food and drug administration is responsible for the supervision and management of national medical devices. The relevant departments of the State Council are responsible for the supervision and management of medical devices within their respective areas of responsibility.
The food and drug administration department of the local people's government at or above the county level is responsible for the supervision and management of medical devices in the administrative region. The relevant departments of the local people's government at or above the county level are responsible for the supervision and management of medical devices within their respective areas of responsibility.
The food and drug supervision and management department of the state council shall cooperate with the relevant departments of the state council, the implementation of national medical device industry planning and policy.
Article 4 of the state of medical devices in accordance with the degree of risk to implement classification management.
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Evaluating the degree of risk of medical devices, should take into account the intended purpose of the medical device, structural features, use and other factors.
The food and drug administration department under the state council is responsible for formulating the classification rules and classification directory of medical devices, and analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the classification directory. The formulation and adjustment of the classification directory shall fully listen to the opinions of the medical device production and operation enterprises as well as the use of units, industry organizations, and refer to the international medical device classification practice. Classification catalog of medical devices shall be published to the community.
Article V The development of medical devices shall follow the principles of safety, effectiveness and economy. The state encourages the research and innovation of medical devices, play the role of market mechanism, promote the popularization and application of new technology of medical devices, and promote the development of medical device industry.
Article VI of the medical device products should be in line with the mandatory national standards for medical devices; there is no mandatory national standards, should be in line with the mandatory industry standards for medical devices.
Disposable medical device directory by the State Council food and drug supervision and management department in conjunction with the State Council department in charge of health planning to develop, adjust and publish. Repeated use can ensure the safety and effectiveness of medical devices, not included in the single-use medical device catalog. Repeated use due to design, production process, sterilization technology and other improvements can ensure the safety and effectiveness of medical devices, should be adjusted out of the directory of single-use medical devices.
Article VII of the medical device industry organizations should strengthen industry self-discipline, promote the construction of integrity system, supervise enterprises in accordance with the law to carry out production and business activities, and guide enterprises to be honest and trustworthy.
Chapter II Medical Device Product Registration and Filing
Article VIII of the first class of medical devices to implement product filing management, the second and third class of medical devices to implement product registration management.
Article IX Class I medical device product filing and application for Class II, Class III medical device product registration, the following information should be submitted:
(a) product risk analysis information;
(b) product technical requirements;
(c) product inspection reports;
(d) clinical evaluation information;
(e) Product specifications and labeling samples;
(f) and product development, production-related quality management system documents;
(vii) to prove that the product is safe, effective and other information required.
Applicants for registration of medical devices, the filer shall be responsible for the authenticity of the information submitted.
Article X of the first class of medical device products for the record, by the filer to the municipal people's government of the location of the food and drug supervision and management department to submit the record information. Among them, the product inspection report can be the filer's self-inspection report; clinical evaluation information does not include clinical trial report, can be through the literature, clinical use of similar products to obtain data to prove that the medical device is safe and effective information.
To export Class I medical devices to the territory of China's foreign manufacturers, by its representative body established in China or designated in China as an agent of the enterprise legal person, to the State Council Food and Drug Administration to submit the filing information and the filer's country (region) competent authorities to authorize the sale of the medical device on the market documents.
Filing information contained in the matter of change, should be filed to the original record department to change the record.
Article XI of the application for registration of Class II medical device products, the applicant for registration shall be located in the provinces, autonomous regions, municipalities directly under the Central People's Government of the Food and Drug Administration to submit an application for registration information. Apply for registration of Class III medical device products, the applicant shall submit an application for registration to the State Council Food and Drug Administration.
To China's exports of Class II, Class III medical devices overseas manufacturers, should be set up by its representative body in China or designated in China as an agent of the enterprise legal person, to the State Council Food and Drug Administration to submit the application for registration information and the registration of the applicant's country (region) the competent authorities to permit the marketing of the medical device documents.
The second class, the third class of medical device product registration application information in the product inspection report shall be a medical device inspection agency issued the inspection report; clinical evaluation information shall include clinical trial report, but in accordance with the provisions of Article 17 of the Regulations are exempted from clinical trials of medical devices.
Article XII of the food and drug supervision and management department shall accept applications for registration within three working days from the date of acceptance of the application for registration information will be forwarded to the technical review body. Technical review body shall complete the technical review to the food and drug supervision and management department to submit the review.
Article XIII of the food and drug supervision and management department shall accept applications for registration within 20 working days from the date of receipt of the review comments to make a decision. To meet the safety and efficacy requirements, granted registration and issue a medical device registration certificate; does not meet the requirements, not registered and a written explanation of the reasons.
The State Council Food and Drug Administration in the organization of the technical review of imported medical devices that it is necessary to verify the quality management system, should be organized to check the quality management system technical institutions to carry out quality management system verification.
Article XIV has been registered Class II, Class III medical device products, its design, raw materials, production processes, scope of application, methods of use and other substantive changes that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department for a change in the registration procedures; non-substantive changes that do not affect the safety and effectiveness of the medical device, the changes should be made to the original registration department for the record. To the original registration department for the record.
Article XV of the medical device registration certificate is valid for five years. The expiration of the validity of the need to renew the registration, should be valid for six months before the expiration of the original registration department to apply for renewal of registration.
Except for the third paragraph of this article, the continuation of the application for registration of food and drug supervision and management departments should be in the medical device registration certificate before the expiration of the decision to grant the continuation. If the decision is not made after the expiration date, the renewal shall be deemed to be granted.
One of the following circumstances, not renewed:
(a) the registrant did not apply for renewal of registration within the specified period;
(b) the mandatory standards for medical devices have been revised, apply for renewal of registration of medical devices can not meet the new requirements;
(c) for the treatment of rare diseases and respond to public **** health emergencies Urgent need for medical devices, medical device registration certificate is not completed within the specified period of time the matters set out.
Article XVI of the newly developed medical devices have not been included in the classification of the catalog, the applicant can apply directly for product registration in accordance with the provisions of this regulation relating to the registration of Class III medical devices, but also based on the classification rules to determine the product category and apply to the State Council food and drug supervision and management department of the category confirmed in accordance with the provisions of this regulation to apply for registration or product filing.
Directly apply for registration of Class III medical device products, the State Council Food and Drug Administration shall determine the category in accordance with the degree of risk, the registration of medical devices granted in a timely manner into the classification catalog. Application for category confirmation, the State Council Food and Drug Administration shall accept the application from the date of 20 working days to determine the category of the medical device and inform the applicant.
Article 17 of the first class of medical device products for the record, do not need to conduct clinical trials. Application for registration of Class II, Class III medical device products, should be clinical trials; however, one of the following circumstances, can be exempted from clinical trials:
(a) the working mechanism is clear, the design is finalized, the production process is mature, and has been listed in the same variety of medical devices for many years of clinical application and no record of serious adverse events, do not change the routine use;
(b) through non-clinical evaluation can prove that the medical device is safe and secure. Clinical evaluation can prove that the medical device is safe and effective;
(C) through the clinical trials of the same variety of medical devices or clinical use of the data obtained by analyzing and evaluating, can prove that the medical device is safe and effective.
Exempted from clinical trials of medical devices catalog by the State Council Food and Drug Administration to develop, adjust and publish.
Article 18 to carry out clinical trials of medical devices, should be in accordance with the requirements of the quality management standard for clinical trials of medical devices, clinical trials in qualified institutions, and to the clinical trial of the proposed location of the provincial, autonomous regions, municipalities directly under the Central People's Government of the food and drug supervision and management department for the record. Accept the record of clinical trials of food and drug supervision and management department shall inform the clinical trial organization where the same level of food and drug supervision and management department and the competent department of health and family planning.
Medical device clinical trial organization accreditation conditions and clinical trial quality management standards, by the state council food and drug supervision and management department in conjunction with the state council department in charge of health planning to develop and publish; medical device clinical trial organization by the state council department of food and drug supervision and management department in conjunction with the state council department in charge of health planning to identify and publish.
Article 19 of the third class of medical devices for clinical trials on human beings with a higher risk, shall be approved by the State Council food and drug administration department. Clinical trials on the human body has a higher risk of third-class medical device directory by the food and drug administration department of the State Council to develop, adjust and publish.
The food and drug administration of the State Council for approval of clinical trials, should be to undertake clinical trials of medical devices, equipment, professionals and other conditions of the institution, the risk level of the medical device, the clinical trial implementation plan, clinical benefit and risk of comparative analysis of the report for a comprehensive analysis. Permitted to carry out clinical trials, should be informed of the clinical trial proponent and the clinical trial organization where the provincial, autonomous regions and municipalities directly under the Central People's Government of the food and drug supervision and management department and the competent department of health and family planning.
Do I still need to renew my license after filing a Class II medical device?
Need, Class II medical device registration certificate is valid for five years (see Article 36), the expiration of the need to renew the registration (see Chapter VII). Class II medical devices are registered, not for the record, a class of medical devices is for the record (see Article V). Measures for the Administration of Registration of Medical Devices (State Food and Drug Administration Decree No. 4) provides that: Article 5 Class I medical devices are managed for the record. Class II and Class III medical devices are subject to registration management. Within the first class of medical devices for the record, the filer to the municipal food and drug supervision and management department to submit filing information. Within the second class of medical devices by the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to review and approve the issuance of medical device registration certificate. Within the third class of medical devices by the State Food and Drug Administration for review, approval issued after the medical device registration certificate. Import of Class I medical devices for the record, the filer to the State Food and Drug Administration to submit the record information. Import of Class II and Class III medical devices by the State Food and Drug Administration for examination, approval and issue of medical device registration certificate. Hong Kong, Macao, Taiwan, the registration of medical devices, for the record, with reference to the import of medical devices. Article 36 accepts applications for registration of food and drug supervision and management departments shall make a decision within 20 working days after the end of the technical review. To meet the safety and efficacy requirements, registration is granted, from the date of approval decision within 10 working days to issue a certificate of registration of medical devices, approved product technical requirements in the form of an attachment to the applicant. Not registered, shall state the reasons in writing, and at the same time inform the applicant the right to apply for review and apply for administrative reconsideration or administrative litigation according to law. Medical device registration certificate is valid for five years. Chapter VII renewal of registration Article 54 of the expiration of the certificate of registration of medical devices need to renew the registration, the registrant should be in the medical device registration certificate expires six months before the expiration of the registration, to the food and drug supervision and management departments to apply for renewal of registration, and in accordance with the relevant requirements for the submission of declarations. In addition to the provisions of Article 55 of these measures, the application for renewal of registration received by the food and drug supervision and management department shall be in the medical device registration certificate before the expiration of the validity of the decision to grant the continuation. Late decision, deemed to be allowed to continue. Article 55 of the following circumstances, not to renew the registration: (a) the registrant did not apply for renewal of registration within the prescribed period; (b) the mandatory standards for medical devices have been revised, the medical device can not meet the new requirements; (c) for the treatment of rare diseases and to deal with public **** health emergencies in urgent need of medical devices, the approval of the registration department in the approval of the listing of the requirements of the registrant has not been completed within the prescribed period of medical device registration. In the specified period of time to complete the medical device registration certificate sets out the matters. Article 56 of the acceptance of applications for renewal of registration of medical devices and approval procedures, this chapter does not provide, the relevant provisions of Chapter V of these measures shall apply.
How to file a class I medical device license?
The first class of medical device products for the record, by the filer to the location of the municipal people's government responsible for drug supervision and management of the department to submit the record information.
Processing materials in general:
1. "Class I Medical Device Filing Form" (the original original (collected) 1, 1 electronic copy)
2. safety risk analysis report (1 electronic copy, a copy of 1)
3. product technical requirements (1 electronic copy, a copy of 1)
4. product inspection report ( Electronic 1, a copy of 1)
5. Clinical evaluation information (electronic 1, a copy of 1)
6. Product manuals and minimum sales unit labeling design samples (electronic 1, a copy of 1)
7. Manufacturing information (electronic 1, a copy of 1)
8. Supporting documents (copy of business license, copy of organization code certificate) Organization code certificate copy) (1 electronic, 1 copy)
9. Declaration of conformity (original original (collected) 1, 1 electronic)
10. Proof of authorization of the operator and the operator's original identity card and a copy of the original (original original (collected) 1, 1 electronic)
Legal basis: "Regulations for the Supervision and Administration of Medical Devices"
Legal basis: "Medical Devices Supervision and Administration"
The first class of medical devices shall be implemented in accordance with Article 13 of the Regulations. Article XIII of the first class of medical devices to implement the product record management, the second class, the third class of medical devices to implement product registration management.
Medical device registrants, filers should strengthen the quality management of medical devices throughout the life cycle, the development, production, operation, use of the whole process of medical devices, safety, effectiveness, and bear responsibility according to law.
Medical device product record number of gold?
Very high
Medical device filing refers to the medical device filer (hereinafter referred to as the filer) in accordance with the statutory procedures and requirements to the drug supervision and management department to submit the record information, drug supervision and management department of the filing of information submitted to the file for inspection of the activities.
The filer shall follow the basic requirements of safety and effectiveness of medical devices before applying for registration or filing, complete the development of medical devices to ensure that the development process is real, standardized, and all data are true, complete and traceable. The development process should meet the relevant requirements of the quality management system.