Drugdu.com expert's response:

Regarding the domestic registration and application materials for medical devices in China, the content requirements are as follows:

Currently, the requirements for domestic medical device registration and application materials are mainly based on the Requirements and Instructions for Medical Device Registration Application Materials issued by the National Medical Products Administration (NMPA). These requirements came into effect on January 1, 2022, and the previous 2014 version was repealed simultaneously. In addition, the Measures for the Administration of Medical Device Registration and Filing clearly stipulates that applications for registration or filing shall submit materials in accordance with the relevant requirements of the NMPA, and applicants and filers shall be responsible for the authenticity of the materials.

The domestic registration and application materials for medical devices mainly consist of 6 major parts:

‌Regulatory Information‌

This section mainly proves "who is applying, what is being applied for, and what is the basis for the application".
It usually includes: the application form, description of terms and abbreviations, product list, associated documents, records of pre-submission communication with regulatory authorities, and compliance statements, etc.
The product list must clearly specify the model, specification, structural composition, accessories, model identification, etc. of the applied product; the compliance statement shall clarify that the product complies with the registration administration measures, classification rules, current national standards and industry standards, and guarantee the authenticity of the materials.

‌Overview Materials‌

This section mainly explains "what the product is".
The content generally includes: the generic name of the product and the basis for its determination, management category, classification code, scope of application, product description, working principle, structural composition, model and specification, packaging description, R&D history, comparison with similar or previous-generation products, applicable population, usage environment, contraindications, listing history, adverse event and recall situations, etc.
This part is critical. A common problem encountered by many enterprises during application is the inconsistency between product description, scope of application, model and specification, technical requirements and the instructions for use, which will easily lead to subsequent correction requests.

‌Non-clinical Materials‌

This section mainly proves "whether the product is technically and safety-wise reliable".
It generally includes: product risk management materials, list of safety and performance basic principles, product technical requirements, inspection reports, research materials, non-clinical literature, stability studies, etc.
Research materials are prepared according to the characteristics of the product, such as chemical and physical properties, electrical safety, electromagnetic compatibility, radiation safety, software research, cybersecurity, biological evaluation, sterilization verification, cleaning and disinfection verification, animal tests, shelf life, transportation stability, usage stability, etc.
Not all products require every item of research, but it is necessary to judge which items are applicable and which are not based on the product structure, purpose, risk points and applicable standards, and explain the reasons.

‌Clinical Evaluation Materials‌

This section mainly proves "whether the product is safe and effective in clinical scenarios".
Class II and Class III medical devices need to provide clinical evaluation materials in accordance with relevant requirements. Clinical evaluation can choose different paths according to the product situation, such as the same-variety clinical evaluation path or the clinical trial path.
If the same-variety clinical evaluation path is adopted, it is generally necessary to explain the comparison between the applied product and the same-variety product in terms of scope of application, technical characteristics, biological characteristics, etc., and form evidence with clinical data.
If the clinical trial path is followed, it is necessary to provide the clinical trial protocol, the opinion of the ethics committee, the clinical trial report, the sample of the informed consent form, and the database and other materials.

‌Draft of Product Instructions for Use and Labels‌

This section mainly proves "how to use the product, how to identify it, and how to prompt risks".
It usually includes the product instructions for use, the draft of the label of the minimum sales unit, and other supplementary explanatory documents.
The content of the instructions for use and labels shall comply with the Regulations on the Administration of Medical Device Instructions and Labels and the requirements of relevant regulations and mandatory standards. Imported products also need to submit the original instructions for use of the product.
Problems easily arise in this part. For example, inconsistencies between the scope of application, contraindications, model and specification, usage method, warning information in the instructions for use and other parts of the registration materials will affect the review.

‌Quality Management System Documents‌

This section mainly proves "whether the enterprise has the ability to stably produce products that meet the requirements".
The materials generally include: quality management system overview, manufacturing information, production address and contact information, information of key suppliers, quality manual, quality policy, quality objectives, document and record control procedures, management responsibility procedures, resource management procedures, design and development procedures, procurement procedures, production and service control procedures, identification and traceability procedures, monitoring and measuring equipment control procedures, measurement, analysis and improvement procedures, etc.
The applicant shall also promise that the corresponding quality management system has been established in accordance with regulatory requirements and accept the verification of the quality management system.

In simple terms, the application materials need to answer 6 questions

The domestic registration application materials for medical devices are not just "gathering certificates and reports", but systematically answering:

What is the product?

Which category does the product belong to?

How is the product designed, manufactured, and how are risks controlled?

Does the product comply with applicable standards?

Has the product undergone necessary inspections, research and clinical evaluation?

Does the enterprise have the capabilities for stable production and quality control?

Therefore, the most important content requirements are: completeness, authenticity, consistency, traceability and well-foundedness.

Special attention should be paid to several types of common problems:

Inconsistencies in product name, model and specification, and structural composition in different parts of the materials;

Overly broad scope of application without sufficient basis;

Mismatch between product technical requirements and inspection reports;

Unclear selection of clinical evaluation paths;

Inconsistencies between instructions for use/labels and other parts of the application materials;

Overly templated quality system documents that cannot correspond to the actual production process;

Insufficient basis for cited standards, guiding principles or same-variety products.