Medical device registration filing personnel is authorized by the legal representative of the medical device manufacturer to handle the medical device registration application affairs (hereinafter referred to as the registration specialist). As a representative of the applicant responsible for the registration application and communication with the food and drug regulatory authorities to assist the applicant to carry out product development in a compliant manner, the registration commissioner is a position requiring a very strong comprehensive ability, the need to have the appropriate professional knowledge, but also must be familiar with the regulations, standards and technical requirements for the registration of medical devices.
A medical device registration specialist should meet the following basic requirements:
(a) honest and trustworthy, abide by the law;
(b) familiar with the relevant laws and regulations of medical device registration; familiar with the declaration of the product, the implementation of standards/technical requirements, medical device specifications, labels and packaging marking and other relevant information;
(c) have good organizational (c) Good organization, communication and coordination skills, with the ability to guide or supervise the relevant departments of the enterprise to implement the medical device registration in accordance with the provisions of the professional skills and the ability to solve practical problems;
(d) Strong ability to learn, and be able to keep abreast of the latest development of medical device registration policies and products;
(e) Have the appropriate professional knowledge. Preferably, the medical device related professional college degree or above, with more than 1 year of medical device registration related work experience; non-medical device related professional, should have more than 2 years of medical device registration related work experience;
Two, the medical device registration specialist should perform the following duties:
(a) standardize the management of the process of the application for registration of medical devices in the enterprise
(ii) communicate and coordinate with the food and drug supervision and management departments;
(iii) pay attention to the State Food and Drug Administration and the provincial Food and Drug Administration website released relevant information, in a timely manner, to grasp the medical device registration-related policies and the latest developments related to the medical device varieties and national and industry standards;
(iv) participate in the enterprise the following Medical device registration application work:
1. medical device registration product standards/product technical requirements, instructions and other registration declaration information preparation;
2. medical device registration sample trial production;
3. clinical trial program approval;
4. medical device registration application information approval;
5. medical device registration Declaration of the application;
6. Application for verification of the authenticity of the registration of medical devices;
7. Withdrawal of the application for registration of medical devices;
8. Other work related to the application for registration of medical devices.
From the perspective of the enterprise, in an enterprise with good R&D capability, from the pre-project research to obtain the marketing authorization, and then after the renewal of registration, the participation of RA personnel throughout the entire life cycle of the product. In addition to organizing information and tracking the review progress according to the format requirements of the FDA, a qualified RA needs to understand the relevant laws and regulations, guidelines, review technical requirements, as well as the FDA's various e-publications and related literature, have knowledge of CMC, GMP, clinical trials, trademarks, patents, and even marketing and sales, be familiar with the design and development process of the medical device, and master the communication skills with the FDA and various departments within the company. and internal departments of the company. In addition to basic skills, senior RAs need to consider the big picture and think strategically;
Legal basis:
Methods for the Administration of Registration and Filing of Medical Devices
Article 3: Registration of a medical device refers to the application for the registration of a medical device by the applicant for registration of a medical device in accordance with the statutory procedures and requirements, and the application for registration of a medical device by the Drug Administration. Medical device registration application, drug supervision and management departments in accordance with laws and regulations, based on scientific knowledge, safety, efficacy and quality control and other reviews, to decide whether to agree with its application activities.
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 for the record of the activities of the archives.