Key practical points:
• Devices are classified: class I low risk, class II medium, class III high risk (such as implants).
• Class I is registered by filing, while class II and III need registration and tighter approval.
• Selling or importing an unregistered or expired device is a penalised violation.
• Distributors and hospitals must verify the supplier's licence and product safety and keep traceability records.
• Imported devices need registration with the national drug authority before entering the market.
• There is a vigilance system for reporting adverse events caused by devices.
Regulations on the Supervision and Administration of Medical Devices · Yalla China
医疗器械监督管理条例 / Regulations on the Supervision and Administration of Medical Devices
Enacted: 2021-02-09 ✅ Effective: 2021-06-01
📝 Overview
A State Council regulation governing the registration, production, sale and use of medical devices by their risk level. It classifies devices into three classes, with stricter control as risk rises. It concerns hospitals, pharmacies, medical-device distributors and importers.
This is general information only, not legal advice. For your specific case, consult a licensed lawyer.
📜 The law text / key provisions
💬 Practical reading
💬 This is a general reading/opinion for orientation — not the official legal text nor legal advice.
If you work in a hospital or pharmacy or distribute medical devices, make sure every device is registered and from a licensed supplier, and keep purchase records. High-risk (class III) devices are the most tightly controlled. General orientation, not legal advice.
📎 Official source
National Medical Products Administration / nmpa.gov.cn
🕒 Updated: 16 March 2026