Medical-device market access in China starts with the product's intended use and risk classification, not its commercial label. The legal route then turns on device class, domestic or imported status, applicant or filing entity, clinical evidence, manufacturing model and the operators that will import, distribute or use the product.
Before launch or responding to an inspection, preserve the classification basis, technical requirements, testing and clinical materials, registration or filing certificate, quality-system records, Chinese label and instructions, supply-chain licences, complaints, adverse-event files and recall decisions. Do not sell outside an approved scope or quietly change a registered product while the regulatory position is unresolved.
Subject to editorial and legal review. Official Chinese texts control. Product classification, local authority practice and the facts of a specific quality event can change the result.
Classify the product and regulatory role
Determine whether the product is a medical device and whether it falls in Class I, II or III under the classification catalogue and applicable rules. Record intended purpose, mechanism, contact type, duration, software functions, accessories and combination-product features. Identify the registrant or filing entity, domestic responsible person for an imported device, manufacturer, contract manufacturer, importer, distributor and user institution. Each role carries distinct duties.
Choose filing or registration
Class I devices generally follow filing; Class II and III devices require registration. Authority allocation differs for domestic and imported products. Build the submission around product technical requirements, testing, risk analysis, clinical evaluation or investigation where required, manufacturing information, label and instructions, and the applicant's quality system. Confirm whether exemptions, innovative-device procedures, emergency pathways or special rules for in-vitro diagnostics or software apply.
Control changes and renewals
After approval, compare every design, material, supplier, manufacturing-site, software, intended-use, label and packaging change against the registered dossier. Decide whether the change needs record maintenance, change registration, a new filing or a new registration before implementation. Track certificate validity and renewal deadlines; commercial inventory does not cure an expired or mismatched authorization.
Manufacturing and entrusted production
Maintain a device quality-management system proportionate to product risk and actual operations. A registrant remains responsible for product safety and effectiveness when production is entrusted. Quality agreements should allocate purchasing, validation, release, deviations, complaints, adverse events, recalls, regulatory communications and audit rights without attempting to transfer statutory responsibility.
Import, distribution and online sales
Confirm the import record, Chinese labelling, customs particulars and responsible domestic entity. Distribution requirements depend on device class and local implementation; check licences or filings, premises, storage and transport, traceability and supplier/customer qualification. Online platforms and sellers have additional verification and display duties. Hospitals and other users must purchase, inspect, store, maintain and trace devices lawfully.
Labels, promotion and evidence
The label and instructions must remain consistent with the approved or filed content and must not imply unapproved uses or guaranteed results. Separate scientific exchange, product information and medical-device advertising analyses. Preserve claim substantiation, review approvals, channel records, distributor materials and training. Distributor or influencer wording can create regulatory exposure even when the registrant did not write the final post.
Post-market surveillance, adverse events and recalls
Operate complaint intake, adverse-event monitoring, risk evaluation, traceability and corrective-action systems. Escalate safety signals promptly and determine reporting, field safety action and recall duties. A recall plan should identify affected lots, customers, communications, recovery, health-risk evaluation and effectiveness checks. Keep product-liability evidence separate but coordinated.
Inspection and enforcement response
On inspection, verify authority and scope, preserve requested records, track samples and copies, correct factual errors and assign owners to each deadline. Potential measures include orders to correct, confiscation, fines, suspension, licence consequences and responsible-person exposure. Do not obstruct officials or create retrospective records.
Working-file checklist
- Intended use, classification basis and product code.
- Registration or filing certificate and approved technical requirements.
- Testing, clinical evaluation and quality-system evidence.
- Manufacturing and quality agreements; supplier controls.
- Chinese label, instructions and promotional claims.
- Import, distribution, storage and traceability records.
- Complaints, adverse events, CAPA and recall decisions.
- Inspection notices, samples, responses and deadlines.
Official sources
- Regulations for the Supervision and Administration of Medical Devices
- Provisions for Medical Device Registration and Filing
- NMPA rules on entrusted medical-device manufacturing
- NMPA medical-device regulatory materials
Law checked: September 12, 2026. Confirm the current classification, authorization and local implementation before acting.
