Drugdu.com expert's response:

For medical device registration certificate application, the first step is not to immediately prepare a large stack of materials, but to determine which risk class the product belongs to. In China, medical devices are categorized into Class I, Class II and Class III based on their risk levels. Class I devices are subject to record-filing management, while Class II and Class III devices are subject to registration management. The "medical device registration certificate application" that enterprises usually refer to mainly targets Class II and Class III products.

For domestic Class III devices, as well as imported Class II and Class III devices, the National Medical Products Administration (NMPA) is responsible for the review, evaluation and approval. Domestic Class II devices are generally registered under the charge of provincial drug regulatory authorities.

After clarifying the product classification, you need to confirm the registration applicant and the production relationship. That is, who will apply for the registration certificate, who will manufacture the product, whether entrusted production is involved, and whether the information such as production address, quality system, test report, instructions for use and labels are consistent. Many enterprises are later required to supplement materials not necessarily because they "missed a document", but because there are inconsistencies between the application subject, production subject, product model, technical requirements and inspection report.

The next step is to prepare product technical documents. The core part here is the product technical requirements, which need to specify the objectively determinable functional and safety indicators of the finished product, as well as the corresponding test methods. Subsequent registration inspection will generally be carried out around the product technical requirements, so this document cannot be written casually. Enterprises also need to prepare product overview materials, structural composition, model specifications, intended use, working principle, risk analysis, non-clinical research data, draft instructions for use and labels, etc.

When the technical documents are prepared to a certain stage, registration inspection should be carried out. The inspection contents vary with different product types, and may involve items such as performance testing, electrical safety, biocompatibility, sterility, microbiology, software, electromagnetic compatibility, etc. The most worrying problem at this stage is that the product model, inspection items and technical requirements are not sorted out in the early stage, resulting in repeated adjustments even after the inspection is completed.

Clinical evaluation also needs to be judged in advance. Not all medical devices are required to carry out clinical trials. Some products can complete clinical evaluation through methods such as same-kind device comparison, clinical literature and existing clinical data. If some products can be included in the catalogue of medical devices exempted from clinical evaluation, the materials can be prepared in accordance with corresponding requirements. However, if the existing data is insufficient to prove that the product is safe and effective, clinical trials may need to be carried out. It is best to confirm this path in the early stage, because it will significantly affect the registration cycle.

At the same time, enterprises also need to prepare documents related to the quality management system. Medical device registration not only examines product documents, but also checks whether the enterprise has the ability to continuously produce qualified products. R&D, procurement, production, inspection, release, traceability, non-conforming product handling, change control and other contents may become the focus of system inspection. For products that require system inspection, the regulatory authority will organize the inspection in accordance with the procedures.

After the inspection, clinical evaluation and system documents are all ready, the registration application materials can be sorted out as required. The NMPA issued the Requirements for Medical Device Registration Application Documents and the Format of Approval Documents via Announcement No. 121 of 2021, which came into effect on January 1, 2022. Registration application documents usually include regulatory information, overview materials, non-clinical data, clinical evaluation data, draft product instructions for use and labels, quality management system documents, etc.

After the materials are submitted, the competent authority will first conduct a formal examination. If the materials meet the requirements, the application will be accepted. After acceptance, the application will enter the technical review and evaluation stage. During this process, the review team may put forward supplementary correction opinions, and the enterprise needs to provide supplementary explanations or submit supplementary materials within the specified time. Some products may also involve system inspection, expert consultation and other links. After the review and evaluation is passed, the drug regulatory authority will make an approval decision, and issue the medical device registration certificate after approval.

Therefore, the process of applying for a medical device registration certificate can be simply understood as: first determine the product classification, then clarify the registration applicant and production relationship, then complete the preparation of technical documents, registration inspection, clinical evaluation and quality system, finally submit the registration application, and obtain the registration certificate after going through the links of acceptance, technical review and evaluation, supplementary correction, inspection and approval.

For enterprises, the three most important matters to confirm in the early stage are: whether the product classification is accurate, whether the technical requirements and inspection path are clear, and whether the registration applicant, manufacturing enterprise and product documents are consistent. The earlier these matters are sorted out, the less likely repeated supplementary corrections will occur in the subsequent application process.