China Officially Implements National Medical Device Vigilance System

China has formally launched and enforced its unified Medical Device Vigilance System, built on the newly issued Good Practice for Medical Device Vigilance (Trial) and a full set of supporting guidelines, marking a major upgrade of post-market surveillance (PMS) regulation covering the full product lifecycle. The regime places registrant responsibility at its core and establishes mandatory requirements for vigilance organization, data collection, risk control, and standardized reporting for all medical devices sold in China.

Vigilance Requirements for Foreign Medical Device Companies

All overseas manufacturers marketing devices in China must designate a legal entity in China (Domestic Responsible Person for Imported Medical Devices) to fulfill vigilance obligations as the primary accountable party onshore. The regulation applies to all Class I, II, and III medical devices already placed on the Chinese market, with enhanced oversight for high-risk products, including implantable devices, life-supporting equipment, innovative devices, pediatric devices, and patient self-use devices.

Vigilance Regulatory Framework

The medical device vigilance system in China is based on the Regulations for the Supervision and Administration of Medical Devices, Provisions for Medical Device Adverse Event Monitoring and Re‑evaluation National Medical Products Administration, and The Good Practice for Medical Device Vigilance (Trial) (effective April 2026) with some supporting guidelines such as vigilance plan, Periodic Safety Update Report (PSUR), Trend Report and Inspection guidelines.

Mandatory Obligations for Overseas Enterprises

1. Establish a Vigilance Organization & System

The overseas medical device manufacturers must set up a Vigilance Leading Group headed by the Chinese local legal representative or principal person in charge, with a dedicated vigilance department and a qualified vigilance officer. And develop vigilance procedures, document control, record-keeping, training, and internal audit mechanisms integrated into your quality management system (QMS).

2. Prepare and Implement a Vigilance Plan

The overseas medical device manufacturers must create a product-specific vigilance plan defining scope, objectives, data sources, risk analysis, risk control, reporting rules, and periodic review and update mechanisms. And clarify triggers and arrangements for proactive post-market clinical follow-up (PMCF) and post-market safety evaluation.

3. Prepare and Submit the Mandatory Reports

The overseas medical device manufacturers must prepare and submit the Periodic Safety Update Report (PSUR), Trend Report, and Vigilance Plan.

The PSUR should include product info, sales volume, user population, vigilance data analysis, trend review, risk control, benefit-risk conclusion, and attachments. For newly registered Class II/III devices, overseas medical device manufacturers must submit a PSUR annually within 60 days after each full year via the national adverse event monitoring system. For renewed registrations, they are required to compile for the full registration cycle and keep it on file for inspection.

The Trend Report is required when the frequency or severity of risks rises significantly beyond predefined thresholds, and shall submit the initial report within 20 calendar days of confirmation; follow-up and final reports as needed until the trend is controlled.

The Vigilance Plan is a mandatory core document outlining the full post-market vigilance program, subject to regulatory review and inspection.

4. Full Life-cycle Risk Control

The Overseas medical device manufactures must collect data from adverse events, complaints, post-market surveillance, service records, literature review, and PMCF studies, and shall implement risk control measures including label updates, design improvements, field safety corrective actions (FSCA), recalls, and urgent communications to healthcare professionals and patients, and the overseas manufactures are also required to complete post-market safety evaluations for high-risk and regulator‑specified devices, submitting study protocols and final reports within required timelines.

How Foreign Manufacturers Comply with the Vigilance System in China

The overseas medical device manufacturers must comply with the vigilance regulatory steps as follows:

- Appoint or confirm your Domestic Responsible Person and align vigilance duties.

- Build or upgrade onshore vigilance organization, personnel, and QMS procedures.

- Finalize product vigilance plans and define PSUR and trend reporting workflows.

- Conduct internal training and gap assessments to achieve full compliance.

The medical device vigilance system in China aligns with international regulatory practices (such as EU MDR vigilance and PMS) while strengthening risk prevention and control throughout the device life-cycle. Full compliance is essential to maintaining market access and protecting patient safety in China.