What steps and procedures should be followed for domestic registration services of medical devices

In China, the domestic registration service for medical devices is a complex and rigorous process aimed at ensuring the safety, effectiveness, and controllable quality of medical devices to protect public health. This process involves multiple stages, including product initiation and development, classification determination, data preparation, application submission, technical review, on-site evaluation, and final registration approval. The following will elaborate on the main steps and procedures required for domestic registration services of medical devices.

1、 Product initiation and development
The first step in medical device registration begins with the product concept stage. Enterprises need to conduct detailed market research to gain a deep understanding of market demand, competitive landscape, and target user preferences. Based on the research results, conduct feasibility analysis and comprehensively consider the possibility of technological implementation, economic benefits, and social benefits. Subsequently, based on the previous research, specific design plans and technical paths were developed, and the product design and development work began.


2、 Classification of Medical Devices
According to the risk level, medical devices are classified into three levels: Class I, Class II, and Class III, each corresponding to different regulatory models. The classification criteria mainly follow the medical device classification rules issued by the National Medical Products Administration. Enterprises can inquire through official channels or apply to local regulatory authorities for classification and definition to clarify the category to which their products belong.




3、 Prepare application materials




Preparing application materials is a crucial step in the registration process. Enterprises need to prepare comprehensive information including registration application forms, product technical requirements, product inspection reports, clinical evaluation materials, product manuals, label samples, quality management system documents, etc. according to the requirements of medical device registration. These materials must be prepared strictly in accordance with relevant requirements to ensure their completeness, accuracy, and compliance with national standards and regulations.




4、 Submit application




Submit the prepared application materials to the corresponding food and drug supervision and management department. Before submission, companies should carefully verify the information to ensure that there are no omissions or errors. For enterprises that need to apply for Class II or Class III medical device registration certificates, they also need to provide a medical device business license.




5、 Acceptance review and technical evaluation




After receiving the application materials, the food and drug regulatory department will conduct acceptance review. Those that meet the requirements will be accepted and a notice of acceptance will be issued. Subsequently, entering the technical review stage, the accepted application materials will undergo technical review to evaluate whether the product meets the safety, effectiveness, and quality controllability requirements of medical devices. Technical review may include performance validation, evaluation of clinical trial data, etc.




6、 On site evaluation




For Class 2 and Class 3 medical devices, strict on-site evaluation is required during the registration process. On site evaluation is an important step in ensuring that medical device manufacturing enterprises have the corresponding production conditions and quality management system. The review team is usually composed of experts and technical personnel from the food and drug supervision and management department. They will go deep into the enterprise site to conduct detailed inspections and evaluations of the production environment, equipment and facilities, process flow, quality control, and other aspects.




During the on-site review process, the review team will focus on key aspects such as production cleanliness control, raw material procurement and management, production process control, product inspection and release, and adverse event monitoring and reporting of the enterprise. In addition, the implementation of the quality management system documents of the enterprise will be verified to ensure the effective implementation of various regulations.




Enterprises need to prepare in advance to ensure that the production site is clean and orderly, equipment is running normally, personnel training is in place, and all relevant record files are ready for reference. For the problems discovered during the review process, enterprises should actively cooperate with rectification and submit rectification reports within the prescribed time to prove that the problems have been effectively resolved.




7、 Registration approval and subsequent supervision




After strict inspection through multiple stages such as acceptance review, technical evaluation, and on-site evaluation, if the product meets the requirements for medical device registration, the food and drug regulatory department will make a registration approval decision in accordance with the law and issue a medical device registration certificate. Enterprises can legally produce and sell related products with this certificate.




However, registration approval is not the end point, but a new starting point. After obtaining the registration certificate, enterprises still need to continue to accept supervision and management from regulatory authorities to ensure that product quality remains stable and meets relevant regulatory requirements. At the same time, enterprises need to regularly submit product quality reports, adverse event reports, etc., so that regulatory authorities can timely understand the product situation and ensure public health and safety.




In summary, the domestic registration service for medical devices is a complex and rigorous process that requires companies to invest a lot of time and effort. But it is precisely such strict supervision that can ensure the safety, effectiveness, and controllable quality of medical devices, and safeguard public health.