Domestic Registration of Non-active Medical Devices: Required Submission Materials Covering Six Core Areas Including Enterprise Qualifications, Product Technology, Quality Systems, Clinical Evaluation, Packaging and Labeling, and After-sales Service. Specific Content and Regulatory Requirements Are as Follows:

I. Enterprise Qualification Documents

Basic Certificates: Provide a copy of the business license (stamped with the official seal and valid), organization code certificate, and tax registration certificate (some regions have merged these into a unified social credit code). If the enterprise already holds a Medical Device Business License, this must also be submitted.
Personnel Qualifications: Include identity proofs, academic or professional title certificates for the legal representative, enterprise leader, and quality supervisor, along with work resumes of quality management personnel. Additionally, provide a list of professional and technical personnel with their qualifications (e.g., copies of ID cards, academic certificates, and professional title certificates).
Special Qualifications: If the product involves innovative medical devices, submit relevant proof documents of passing the innovative medical device review. If the product requires emergency approval, provide emergency approval-related proof.

II. Product Technical Documents

Product Overview: Provide a detailed description of the product's design principles, structural features, and performance indicators. For example, for a disposable sterile urethral dilator, explain that it consists of a rigid guidewire and a soft catheter, with possible coatings or radiopaque markers on the catheter surface, and identify each component's name and important dimensional information (e.g., effective catheter length, outer diameter).
Research and Development Materials: Include research and development reports, design drawings, technical parameters, test results, and data analysis. For products with coatings, conduct studies on coating integrity and lubricity.
Production Process Flow: Provide a flowchart of the product's production process, highlighting key and special processes. For example, for catheters made of polymer materials, explain the processing methods and key process parameters.
Raw Materials and Components: Provide specifications, models, quality standards, and supplier qualification documents for raw materials, components, and assemblies. For polymer catheter products, specify the chemical name, trade name/brand, material standards, and supplier information.
Product Quality Standards: Develop product quality standard documents that comply with national or industry standards, clearly defining performance indicators, testing methods, and acceptance criteria.

III. Quality Management System Documents

Quality Manual: Describe the quality policy, objectives, and overall requirements of the system, clarifying the scope, processes, and interactions of the quality management system.
Procedure Documents: Cover operational norms for the entire chain, including procurement, production, inspection, and sales, ensuring quality control at each link is well-regulated.
Work Instructions: Provide specific operational guidance documents, such as equipment operation procedures and inspection work instructions.
Quality Records: Provide records of incoming inspection, in-process inspection, finished product inspection, and internal audit reports to demonstrate the effective operation of the quality management system.

IV. Clinical Evaluation Materials

Products Exempt from Clinical Evaluation: If the product is listed in the "List of Medical Devices Exempt from Clinical Evaluation," prove its basic equivalence to products in the list through comparative descriptions. For example, for a disposable sterile urethral dilator, if its structural composition and performance indicators are consistent with those in the list, clinical evaluation materials may be exempted.
Products Requiring Clinical Evaluation: If the product cannot prove its basic equivalence to products in the list, submit clinical evaluation materials in accordance with relevant guidelines. For Class II medical devices, clinical evaluation can be completed through comparison with similar products; for Class III medical devices, a complete clinical trial report must be submitted. The clinical trial protocol must clearly define efficacy evaluation indicators, adopt internationally recognized evaluation standards or clinical routine efficacy evaluation standards, and ensure that the sample size meets statistical requirements.

V. Packaging and Labeling Materials

Packaging Information: Explain the product's packaging materials, packaging forms, and packaging integrity verification methods. For sterile medical devices, describe the information on the sterile barrier system; for medical devices with microbial limit requirements, describe the packaging information that maintains microbial limits.
Label Specimen: Provide a specimen of the product label, which should include information such as product name, model/specification, production date, expiration date, production batch number, manufacturer's name, and contact information. For implantable medical devices, the label must also indicate "Implantable Medical Device."
Instruction Manual Specimen: Provide a specimen of the product instruction manual, which should include information such as the product's structural composition, intended use, contraindications, usage methods, precautions, and warning information. For example, for a disposable sterile urethral dilator, the instruction manual must clearly state that it is intended for urethral dilation, with contraindications including patients with acute urinary tract infections or those with urethral occlusion or severe stenosis that prevent insertion.

VI. After-sales Service Materials

After-sales Service Policy: Provide the product's after-sales service policy, clearly defining the warranty period, warranty scope, and after-sales service contact information.
Maintenance and Care Guide: Provide a maintenance and care guide for the product, guiding users on correct usage and maintenance to extend the product's service life.