Before, many friends asked a lot of questions about the self-inspection of medical device registration in private messages. Today, I will talk to you about the relevant content of medical device registration self-inspection.
What is medical device registration self-inspection
Medical device registration self-inspection refers to the inspection work carried out by the registration applicant in the process of medical device registration application. According to the "Regulations on the Administration of Self-inspection of Medical Device Registration", the registration applicant shall have the ability to self-inspect, and incorporate the self-inspection work into the medical device quality management system, be equipped with inspection equipment and facilities suitable for product inspection requirements, have corresponding quality inspection departments or full-time inspectors, strictly control the inspection process, ensure that the inspection results are true, accurate, complete and traceable, and bear the main responsibility for the self-inspection report.
Why do you need to conduct a medical device registration self-inspection?
Medical device registration self-inspection is to ensure the safety, effectiveness and quality controllability of medical devices. The following are the main reasons for conducting medical device registration self-inspection:
1.Compliance with regulatory requirements: All countries have strict regulations and standards for the production and sales of medical devices, and enterprises need to ensure that their products meet the relevant regulatory requirements through self-inspection to avoid legal risks caused by non-compliance.
2.Guarantee product quality: self-inspection can help enterprises find problems in product design, production, inspection and other links, rectify them in time, improve product quality, and reduce the rate of defective products.
3.Improve product competitiveness: Through self-inspection, enterprises can optimize product design, improve product performance, and enhance brand image, so as to stand out in the market competition.
4.Risk reduction: Medical devices may pose certain risks to patients during use, and these risks can be reduced through self-inspection to ensure patient safety.
5.Promote the development of enterprises: self-inspection helps enterprises to establish and improve the quality management system, improve the management level and technical level of enterprises, and lay the foundation for the long-term development of enterprises.
6.Convenient supervision: Medical device registration self-inspection can provide relevant information for enterprise self-inspection for the regulatory authorities, facilitate the supervision of enterprises by the regulatory authorities, and ensure the healthy development of the medical device market.
What problems are often encountered in medical device registration self-inspection?
A series of problems may be encountered during the medical device registration self-inspection process. Here are some common questions and considerations:
1.Explanation of the inspector information form: In view of the fact that the professionalism of the inspectors and the number of years they have been engaged in this position are very important to the quality of the self-inspection report, in order to better standardize the self-inspection work, the information sheet of the self-inspection inspectors is required to be submitted in the registration application materials. This helps regulators understand the company's inspection staffing.
2.Instructions for filling in the equipment configuration form for inspection: The inspection clauses in the "Annex 2 Configuration Table for Medical Device Self-inspection Equipment (Including Standard and Reference Products)" should be consistent with the corresponding clauses in the product technical requirements.
3.Description of product model coverage: The registration applicant shall conduct a difference analysis of all models of the declared product, and can prove that the performance indicators of the models in the self-inspection report can cover all models by testing the items of the difference part.
4.On-site inspection requirements: The regulations clearly require that during the on-site inspection of the registered quality management system, the "self-inspection capability requirements" should be verified item by item and elaborated in the on-site inspection report.
5.Requirements for self-inspection ability: The registration applicant shall have self-inspection ability and incorporate self-inspection into the medical device quality management system. In addition, it is also necessary to be equipped with inspection equipment and facilities that are compatible with product inspection requirements.
6.Regulations of the State Drug Administration: The "Regulations on the Administration of Medical Device Registration Self-inspection" formulated by the State Drug Administration is the main regulatory basis for the registration and self-inspection of medical devices.
7.Summary of common problems: For example, the Shanghai Instrument Audit Center has conducted on-site inspections of the registration system of several enterprises that have carried out registration self-inspection, and has summarized and released the common problems found for the reference of other enterprises.
How to conduct a medical device registration self-inspection
In order to strengthen the registration management of medical devices and standardize the registration self-inspection of registration applicants, the State Drug Administration issued the "Regulations on the Administration of Medical Device Registration Self-inspection". The main purpose of this provision is to ensure the orderly development of the registration review of medical devices.
According to this provision, the self-inspection of medical device registration mainly includes the following aspects:
1.Self-test ability requirements: The self-test ability standards that registration applicants should have are clarified.
2.Self-test report requirements: The content, format and submission requirements of the self-test report are specified.
3.Requirements for commissioned inspection: For some specific situations, the conditions and procedures for entrusting a third party to conduct an inspection are specified.
4.Requirements for application materials: The information related to self-inspection that needs to be submitted in the registration application is clarified.
5.On-site inspection requirements: In some cases, the conditions and procedures under which the drug regulatory authority can conduct on-site inspections are specified.
6.Responsibility requirements: For violations of self-inspection regulations, the corresponding legal responsibilities are clarified.
In addition, in order to help registration applicants better understand and implement these regulations, the NMPA has also provided relevant training information and interpretation of policies and regulations. It is recommended that the registration applicant carefully read the relevant regulations and ensure that his self-inspection work meets the requirements to ensure the smooth progress of the medical device registration review.
The above is some of the relevant knowledge of medical device registration self-inspection. If you want to consult more medical device registration, medical device commissioned production and other related questions, you can leave a message to us!
Original article**: Zeli Krypton official**: