🇨🇳 China medical device regulatory data

The medical device registration certificate is valid for 5 years. Class I filing has no ordinary 5-year certificate.

Renewal (延续注册) must be applied for with the original registering authority at least 6 months before the certificate expires.

If the authority fails to decide on a timely renewal application within the statutory time limit, the renewal is deemed approved.

Substantive changes to a registered Class II/III device (design, raw materials, production process, intended scope of use, method of use, etc.) that may affect safety or effectiveness require change registration (变更注册) applied for with the original registering authority.

Changes to a registered device other than those requiring change registration must be filed (备案) with the original registration authority within 30 days from the date of the change.

An overseas registrant exporting Class II/III devices to China must designate a Chinese legal-person enterprise (我国境内企业法人, the China agent) that submits the registration application to NMPA on its behalf; the foreign manufacturer remains the registrant/holder.

The China agent designated by an overseas holder must carry out adverse-event monitoring for the imported devices sold in China and cooperate with the overseas holder in re-evaluation obligations; holder and agent must maintain an information-transfer mechanism.

Labels and IFUs must use Chinese, conforming to national language norms; other languages may be added, but the Chinese text prevails.

Imported devices must have a Chinese IFU and Chinese label; the IFU must state the country of origin and the name, address and contact details of the China legal-person enterprise designated by the overseas registrant/holder. Devices without compliant Chinese labels may not be imported.

The National Medical Products Administration (NMPA, 国务院药品监督管理部门) is responsible for supervision and administration of medical devices nationwide.

Device regulation is exercised at three administrative levels: NMPA (national), provincial drug regulatory departments, and municipal (prefecture-level, 设区的市级) departments. For example, domestic Class I product filing is submitted to the municipal-level department.

Primary legislation: Regulations on the Supervision and Administration of Medical Devices (医疗器械监督管理条例), State Council Decree No. 739, in force since 2021-06-01.

A medical device is any instrument, apparatus, implement, in-vitro diagnostic reagent or calibrator, material or other similar or related item used directly or indirectly on the human body, including required computer software, whose action is obtained mainly by physical means and not by pharmacology, immunology or metabolism (which may play only an auxiliary role). IVD reagents, calibrators and software fall inside the device definition.

Class I devices are subject to product filing (备案); Class II and Class III devices are subject to product registration (注册) with acceptance, technical review and administrative decision.

Domestic Class II registration is reviewed and approved by provincial drug regulatory departments; domestic Class III and all imported devices (Class I filing and Class II/III registration) are handled by NMPA, with CMDE (NMPA center for medical device evaluation) conducting technical review of NMPA-level applications.

For import Class II/III registration the designated China agent submits, together with the application dossier, the marketing-approval certificate issued by the regulator of the registrant's home country/region. The certificate functions as an eligibility/documentary gate, not a reliance route: NMPA still performs its own full review.

Innovative medical devices not yet marketed outside China need not submit the home-country/region marketing-approval certificate in the import filing/registration.

Manufacturing Class II or III devices requires a production license (生产许可) applied for from the provincial drug regulatory department, supported by evidence of GMP compliance and the device registration certificate.

Distribution controls are tiered: operating Class II devices requires filing (备案) with the municipal drug regulatory department; operating Class III devices requires an operation license (经营许可) from the same municipal department.

NMPA Announcement No. 121 of 2021 prescribes the mandatory registration dossier requirements and the certificate/decision document formats, with separate annexes for first registration, change, renewal and clinical-trial approval submissions; effective 2022-01-01, repealing the 2014 No. 43 formats.

Device licensing items are standardized and published on the NMPA government service portal (zwfw.nmpa.gov.cn) as 办事指南 items covering forms, materials, fees and statutory clocks; e.g. import Class III first registration is administered by NMPA as a national-level administrative licensing item.

The revised Medical Device GMP (医疗器械生产质量管理规范) takes effect 2026-11-01 and simultaneously repeals the 2014 GMP (CFDA Announcement No. 64 of 2014, in force since 2015-03-01). Until 2026-11-01 the 2014 GMP remains the manufacturing QMS standard.

During registration review, the drug regulatory department organizes a quality-management-system verification (registration QMS check) when it considers one necessary.

Registration fees are waived for innovative medical device registration applications filed by small and micro enterprises (小微企业), per the NMPA administrative licensing fee schedule.

For high-risk Class III clinical-trial approval applications, CMDE must decide whether to agree within 60 days of acceptance and notify the applicant via the CMDE website; if no notice is given within the period, the trial application is deemed agreed (silence = consent).

Where supplementary information is required during review, the applicant must deliver all requested items in a single submission within 1 year of receiving the notice; failure leads to termination of the technical review or rejection of the application.

UDI is implemented in batches: from 2021-01-01 the first 9 categories / 69 types of Class III devices; from 2022-06-01 all other Class III devices including IVDs; from 2024-06-01 the third batch covers selected Class II devices (high-volume single-use, centralized-procurement and medical-aesthetics products), devices in scope produced from that date must carry a UDI, and new registration applications must submit the UDI-DI of the smallest sales unit in the registration system.

Following implementation across all Class III devices (incl. IVDs) and 103 Class II device types, all Class II devices (including IVDs) and all Class I IVDs produced from 2027-06-01, and all Class I devices produced from 2029-06-01, must carry a UDI.

NMPA operates the national UDI database; registrants/holders must upload the product identifier (UDI-DI) and related data to the database, per the UDI System Rules (NMPA Announcement No. 66 of 2019).

Registration/filing requires clinical evaluation unless a Decree Art. 24 exemption applies; evaluation may be satisfied either by a clinical trial or by analysis of clinical literature and data of equivalent (same-variety) devices. Clinical trials must follow medical device GCP at qualified trial institutions, with filing to the provincial drug regulatory department.

Clinical trials of Class III devices presenting high risk to the human body require prior NMPA approval before the trial may proceed; the approval application is decided within 60 days with silence deemed consent.

Devices for rare diseases, life-threatening conditions without effective treatment, or public-health emergencies may receive conditional approval (附条件批准) with the conditions recorded in the registration certificate; for emergency use, NMPA may, after organized assessment and consent, permit use of devices within a defined scope and period.

Registrants/holders must: establish and maintain a functioning QMS suited to the product; formulate and effectively implement post-market research and risk-control plans; conduct adverse-event monitoring and re-evaluation as required by law; and establish and operate product traceability and recall systems.

Holders must complete a periodic risk evaluation report (定期风险评价报告) for the previous year within 60 days after each anniversary of first approval/filing; NMPA-registered products report to the national monitoring centre and provincially registered products to the provincial centre; Class I reports are retained by the holder.

Reporting follows the report-if-suspicious (可疑即报) principle: events that led or may lead to serious injury or death must be reported (innovative devices: all events in the first registration cycle). Individual deadlines: fatal events within 7 days; serious injury or possible serious injury/death within 20 days; events occurring overseas known to the holder within 30 days; evaluation results reported to the provincial monitoring centre within 30 days (death) or 45 days (serious).

Group (群体) adverse events must be reported within 12 hours by phone/fax to the provincial drug regulatory and health departments where the event occurred, with basic information entered in the national monitoring system and each individual case reported within 24 hours; the holder must immediately suspend production and sales, notify user units to stop use, investigate, run a QMS self-inspection, and report to both provincial authorities and monitoring institutions within 7 days.

Where a registered/filed device fails mandatory standards or the registered product technical requirements, or has other defects, the registrant/holder must immediately stop production, notify operators, user units and consumers to stop operation and use, recall marketed units, take remedial or destruction measures, record and publish information, and report the recall and handling to the drug regulatory and health authorities.

Recalls are classified by hazard severity (Art. 13: Level 1 = possible/actual serious health harm; Level 2 = temporary or reversible harm; Level 3 = lower likelihood of harm but recall warranted). After deciding a recall, the manufacturer must notify operators/user units or users within 1 day (Level 1), 3 days (Level 2) or 7 days (Level 3). Level 1 recall notices are published on the NMPA website and central major media; Level 2/3 on provincial department websites (Art. 14). For recalls, the responsible manufacturer includes the China agent designated by the overseas manufacturer (Art. 3).

Medical device advertising must be reviewed before publication by the advertising review authority designated by the province, and an advertisement approval number obtained;未经审查，不得发布. Content must be true and lawful, based on the registered/filed device IFU, without false, exaggerated or misleading claims.

Applicants who disagree with an approval conclusion on NMPA licensing items may seek administrative reconsideration (行政复议) by NMPA or file administrative litigation (行政诉讼).