Medical Device Registration Technical Review Guidelines and Regulations

Provinces, autonomous regions, municipalities and autonomous regions Food and Drug Administration, Examination Center:

In order to strengthen the standardized management of the revision of the guiding principles for the review of medical device registration and medical device registration, the drug The supervision authority organized and formulatedmedical instruments The Code of Practice for the Management of Registered Technical Review Guiding Principles is hereby issued and is implemented from the date of its publication.

State Drug Administration Office

May 28, 2018

Article 1 This standard shall be formulated for the purpose of strengthening the standardized management of the technical review of medical device registration and medical device registration (hereinafter referred to as the guiding principle), and improving the quality of registration examination.

Article 2 This Code applies to the application of the guiding principles and revisions, the preparation of reviewing schools, soliciting opinions, auditing, publishing, revision and repeal.

The third guiding principle is issued by the State Drug Administration (hereinafter referred to as “the State Bureau”) to regulate the technical review of medical device registration and guide the registration of medical device registration applicants. The guiding principle is to guide registration and technical review guidance documents. , does not involve administrative matters such as registration and approval, nor is it enforced by law. If other methods can meet the requirements of the regulations, they can also be adopted, but detailed research data and verification data should be provided. They should be used in accordance with the relevant laws and regulations. Guiding Principles.

4. The revision of guiding principles should follow the principles of scientific rigor, openness and fairness, and encouragement of innovation.

Article 5 The National Bureau is responsible for the management of the guiding principles and revisions. The former Medical Device Technology Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the “Examination Center”) is responsible for the technical organization of the principles and revisions, and the provincial drug supervision and administration department. To support and organize the implementation of the revision of guiding principles.

Article 6 Encourage research institutes, medical institutions, trade associations, testing institutions, production enterprise Such units participate in the revision of guiding principles, make full use of social resources, give full play to the role of social participation, and promote the application of guiding principles.

Article 7 Guiding Principles The applicant for the project (hereinafter referred to as the applicant) shall be an examination center, provincial medical device review agencies, or related units that have the necessary conditions.

The applying unit shall apply for the formulation or revision of the guiding principles. In principle, it shall apply to the equipment examination center in September each year and submit the “Application Form for Medical Device Registration Technical Review Guiding Principles Formulating Project” and/or the “Medical Device Registration Technical Review Guidelines Revised Item. Application Form. For projects that are in urgent need of work, the examination and examination center may propose or revise plans as needed.

Article 8 The guiding principles for the formulation of applications shall meet one of the following conditions:

(i) Conformity to the relevant planning or requirements of the guidelines of the State Bureau;

(2) being representative and capable of guiding the technical review of such products;

(3) It is versatile and capable of guiding registered technical review work;

(4) Reflecting forward-looking, it can promote innovation and development;

(5) It has certain complexity and needs to further standardize the review.

Article 9 The guiding principles for applying for amendments shall meet one of the following conditions:

(i) The current law Regulation Adjustments have been made and have a significant impact on the content of the guiding principles;

(II) With the development of science and technology, great changes have taken place in the product's mechanism of action, structure composition, and scope of application;

(iii) Changes in the level of awareness of product safety and effectiveness;

(iv) Other situations where the guiding principles need to be revised.

Article 10 The examination center organizes the project guiding and principle revision project establishment meeting, and examines the declared project according to the supervision requirements and the ability conditions of the application unit.

Article 11 The equipment examination center shall submit the guiding principles of the proposed project to the State Bureau for examination and approval. For the approval of the project, the equipment examination center shall sign the project contract with the application unit to clarify the responsibilities and obligations of both parties.

Article 12 The National Bureau will approve the establishment of the Guiding Principles and the revision plan on its website.

Article 13 The application unit shall determine the guiding principles of the project and the members of the project team. If necessary, relevant experts and industry representatives may be invited to participate in the work.

Article 14 The application unit shall prepare a work plan, including the work objectives, working methods, expected progress, and acceptance. standard Contents, etc. Within 30 days after the contract is signed, the applicant submits the work plan to the Censorship Center. The application unit should be completed within one year in principle.

Article 15 The applicant shall start the project according to the opening question, report it in the mid-term, and gradually carry out the procedures for soliciting comments and reviewing the final draft to ensure the quality of the guiding principles.

Article 16 The applicant shall conduct research on production enterprises, medical institutions, provincial-level drug regulatory agencies, provincial-level technical review agencies, adverse event monitoring agencies, and medical device inspection agencies according to the needs of the preparation work, and collect product development and production. The main issues and opinions in the inspection, clinical evaluation, and use are focused on the following points:

(i) compliance with relevant laws and regulations, mandatory national and industry standards;

(b) To propose feasible solutions to the actual problems involved;

(3) Based on the current level of scientific and technological understanding and existing product technologies, fully consider the current status of domestic industries and the international development direction;

(IV) Compliance with the “Requirements for the Formatting of the Guidelines for the Registration of Technical Registration of Medical Devices”.

Article 17 The examination center shall be responsible for the quality control of all technical content of the guiding principles. The applicant shall fully seek the opinions of the examination center.

Article 18 The application unit shall do a good job of summarizing feedback from the survey, explain the contents of the amendments to the opinions adopted, explain the reasons for the opinions that are not adopted, and revise the guiding principles according to the feedback opinions, and submit the draft for consultation to the equipment examination center in time.

Article 19 The examination and examination center shall publicly solicit comments on the guiding principles on its website for soliciting opinions from the public. The deadline for soliciting opinions is 30 days.

Article 20 The applicant shall properly handle the opinions of the public solicitation, form a draft for review after revision and improvement and finally review, and report to the examination center in time.

Article 21 The organ of the examination and examination center shall submit the guiding principles submitted by the applicant for review. The personnel of the examination and approval shall include administrative examiners, technical reviewers and relevant experts.

Article 22 The applicant shall report the guiding principles for the review of the school's opinions at the audit meeting, solicit the opinions and the adoption of the amendments. The auditors conduct the audit in accordance with the following requirements:

(1) Whether the applicant has completed the revision according to the opinions of the reviewing school and opinions solicited, whether the content adopted and modified is scientific and reasonable, and whether the reason for not adopting is adequate;

(b) whether the guiding principles can play a guiding role in the registration of technical examinations;

(iii) Whether the guiding principles have solved the problems encountered in the registration of technical review.

Article 23 If the audit conclusion is 'passed', the applicant shall revise the guiding principles according to the audit opinion and submit it in a timely manner. If the audit conclusion is 'not passed', the project will be terminated or transferred to the next year's revision. jobs.

Article 24 The examination center shall report to the State Administration after reviewing and submitting the draft for guidance.

Article 25 The National Bureau shall review the guiding principles and submit it on its website in the form of a notice issued by the Bureau. For the issuing guidelines, the examination center will explain the technical details with the relevant units.

Article 26 The equipment examination center shall collect feedback on the issued guiding principles and forward the relevant opinions to the original application unit for analysis and evaluation. The guiding principles for the application of the situation in Article 9 of this Code shall be revised according to the relevant procedures, Applicable laws and regulations are applicable and are not suitable for amendments.

Article 27 The National Bureau shall no longer apply the existing laws and regulations, and shall not revise the Guiding Principles, or the Guiding Principles to be replaced, after its deliberation.

Article 28 The reviser is a guiding principle for the organizational organization of the applicant organization. It is revised and improved through investigations and opinions, soliciting opinions and other measures, and forms the process of submitting the manuscript for review. The audit is the guiding principle for the formation of the applicant unit by the device examination center. The process of reviewing and confirming is mainly to review whether it has completed the modification according to the feedback, and whether it can play a guiding role in the technical review of the registration. The validation is the process of the normative review and approval release of the guiding principles reported by the national auditing center. .

Article 29 The funds required for the revision of the guiding principles shall be guaranteed according to the relevant provisions of the State Bureau.

Article 30 This specification shall come into force as of the date of promulgation.