The applicant for medical device registration refers to the person authorized by the legal representative of the medical device manufacturing enterprise to apply for medical device registration (hereinafter referred to as the registrant). As the representative of the applicant, the registrar is responsible for the registration application, communicating with the food and drug supervision department, and assisting the applicant to carry out product research and development in compliance. It is a post with strong comprehensive ability, which requires corresponding professional knowledge and familiarity with the regulations, standards and technical requirements of medical device registration.
Medical device registrars shall meet the following basic requirements:
Honest and trustworthy, law-abiding;
(two) familiar with the relevant laws and regulations of medical device registration; Familiar with the declared products, implementation standards/technical requirements, medical device specifications, labels and packaging labels and other related information;
(3) Having good organization, communication and coordination skills, and having the professional skills and the ability to solve practical problems that can guide or supervise the relevant departments of the enterprise to implement medical device registration according to regulations;
(four) have a strong learning ability, can grasp the latest trends of medical device registration policies and products in a timely manner;
(5) Having corresponding professional knowledge. College degree or above in medical device related major is preferred, with 1 year or above medical device registration experience; Non-medical device related majors should have more than 2 years of relevant work experience in medical device registration;
Two, the medical device registration commissioner shall perform the following duties:
(1) Standardizing the management of the application process of medical device registration in this enterprise;
(two) communication and coordination with the food and drug supervision and management departments;
(3) Pay attention to the relevant information published on the websites of the State US Food and Drug Administration and the provincial US Food and Drug Administration, and keep abreast of the latest trends in the policies related to medical device registration, medical device varieties and national and industry standards;
(four) the following medical device registration applications of participating enterprises:
1. Preparation of registration application materials such as medical device registration product standards/product technical requirements and specifications;
2. Trial production of registered samples of medical devices;
3. Approve the clinical trial scheme;
4. Examination and approval of application materials for medical device registration;
5. Declaration of medical device registration application;
6 medical device registration authenticity verification application;
7. Withdraw the application for registration of medical devices;
8. Other work related to medical device registration application.
From the enterprise's point of view, in the enterprise with good R&D capability, RA personnel participate in the whole product life cycle, from the research before the project is established, to the approval for listing, and then to the continued registration after listing. A qualified RA personnel not only need to organize materials according to the format requirements of the Food and Drug Administration and track the progress of the review, but also need to understand the relevant laws and regulations, guiding principles, technical requirements of the review, various electronic publications and related documents of the Food and Drug Administration, have knowledge of CMC, GMP, clinical trials, trademarks, patents and even marketing, be familiar with the design and development process of medical devices, and master the communication skills with the Food and Drug Administration and various departments within the company. Besides basic skills, high-level RA personnel need to consider the overall situation and think strategically.
Legal basis:
Measures for the administration of medical device registration and filing
Article 3 Medical device registration refers to the activity that an applicant for medical device registration (hereinafter referred to as the applicant) submits an application for medical device registration according to legal procedures and requirements, and the pharmaceutical supervisory and administrative department reviews its safety, effectiveness and quality controllability on the basis of scientific cognition according to laws and regulations, and decides whether to approve its application.
Medical device filing refers to the activities that medical device filers (hereinafter referred to as filers) submit filing materials to the pharmaceutical supervisory and administrative departments in accordance with legal procedures and requirements, and the pharmaceutical supervisory and administrative departments file the submitted filing materials for future reference.