Class I medical devices in China are not registered but filed. Domestic manufacturers file with the medical products administration at municipal level where they are located; foreign manufacturers file with the National Medical Products Administration (NMPA) through their Chinese agent. This article explains the documents required for the first filing.
Overview of the filing dossier
- Class I medical device filing form
- Related documents
- Product technical requirements
- Product test report
- Instructions for use and label drafts
- Manufacturing information
- Declaration of conformity
Related documents
- Contract manufacturing: if production is outsourced, provide the contract manufacturer’s qualification documents (copy of the business licence), the manufacturing agreement and the quality agreement. These define the rights and obligations of both parties and safeguard product quality.
- Imported devices: the appointment letter and business licence of the Chinese agent, and evidence that the device may be marketed in the manufacturer’s country (region) of registration or manufacture.
Product technical requirements
- Content: product name; models and specifications and how they are distinguished; performance indicators; test methods; appendices where needed for descriptive characteristics; and the number of the technical requirements.
- Guidance: the NMPA guideline for drafting product technical requirements (No. 8 of 2022).
Product test report
- Type: either a registration test report and pre-evaluation opinion from a qualified medical device testing institution, or the company’s self-test report.
- Requirements: a full-performance self-test report or a report from a commissioned laboratory, tested on a representative product. Attach photos of the product with all packaging removed and of the inner and outer packaging. For several models, photos of the representative product are sufficient.
- Guidance: the NMPA provisions on registration self-testing of medical devices (No. 126 of 2021).
Instructions for use and labels
- IFU content: product name, model and specifications; manufacturer name, registered address, manufacturing address and contact details; filing number (left blank when filing); number of the product technical requirements; performance, main structure and scope of application; contraindications, precautions and other warnings; explanations of graphics, symbols and abbreviations used on the label; installation and use instructions or diagrams; maintenance and care, special storage conditions; and the expiry date for products with a limited shelf life. Performance stated in the IFU must match the product technical requirements.
- Guidance: the Provisions for Medical Device Instructions for Use and Labels (CFDA Order No. 6).
Manufacturing information
- Passive devices: describe the manufacturing process and identify key processes.
- Active devices: describe the production process, for example as a flowchart or process overview.
- IVD reagents: summarise the main production process, including the solid phase carrier and detection system and the rationale for them, and the reaction system – specimen collection and handling, specimen requirements and volume, reagent volume, reaction conditions, calibration (where applicable) and quality control.
- If there are several development or production sites, describe each site; for contract manufacturing, list the contract manufacturer’s name, domicile and manufacturing address.
Declaration of conformity
The filer declares that the product meets the filing requirements, conforms to the classification rules and catalogue as a class I device, meets applicable national and industry standards, and that the submitted documents are true and complete.
FAQs
Is a risk analysis required for the filing?
No, it does not have to be submitted for filing. It is nevertheless essential for ensuring safety and effectiveness: the company should prepare a risk management report documenting how hazards were considered during design and development and eliminated or reduced to an acceptable level – including energy, biological, environmental and use-related hazards and hazards from functional failure, inadequate maintenance and ageing. Relevant standards are GB/T 42062-2022 (application of risk management to medical devices, equivalent to ISO 14971) and YY/T 1437-2023 (guidance on the application of GB/T 42062).
Is clinical evaluation data required?
No. Clinical evaluation data do not need to be submitted for class I filing – see the NMPA notice on implementing the registration and filing measures for medical devices and IVD reagents (No. 76 of 2021).
How EVERBIZ can help
EVERBIZ has extensive experience in quality systems and product registration in China and supports foreign manufacturers with class I filings, agent services and NMPA registrations. Contact us.
This article is for general information only and does not constitute legal advice. Current NMPA requirements are authoritative.