NMPA Medical Device Regulation Highlights 2025 Enforcement Cases on Online Sales in China

Regulation and enforcement of online medical device sales in China have continued to increase, two recent authority announcement emphasise. The National Medical Products Administration (NMPA) announced four enforcement cases on April 15, 2025, involving non-compliant online sales of medical devices, citing issues such as lack of proper qualifications, discrepancies in product information, and unauthorized operations. In April 2025, NMPA also officially released the “Medical Device Online Sales Quality Management Standards”, which will be fully implemented on October 1, 2025. These Standards increase scrutiny and restrictions of online sales of MedTech in China.

Four Typical Cases Reveal Issues in Medical Device Online Sales

In recent years, China's medical device online sales market has grown rapidly, but compliance issues have become increasingly prominent. On April 15, 2025, the National Medical Products Administration (NMPA) reported four cases of illegal online sales of medical devices, involving various issues such as lack of qualifications, product information discrepancies, and illegal sales. These cases serve as a warning to international manufacturers, highlighting China's strict stance on online sales regulation of medical devices.

• Incomplete Qualification Display: The Enterprise Faces "Secondary Penalties"
  A company selling electronic blood pressure monitors and medical masks on the Taobao platform was ordered to rectify after failing to display the medical device registration certificate as required, and ultimately faced administrative penalties.
• Product Information Does Not Match Registration Content
  A company sold one type of gel through an e-commerce platform, with labels indicating a scope of application far beyond the registered range, suspected of misleading consumers. Such actions directly violate the "Regulations on the Supervision and Administration of Medical Devices" and face the risk of high fines and product removal.
• Selling Unregistered Class II Medical Devices
  A company sold silicone gel products on an e-commerce platform without a legal registration process and without implementing an incoming inspection system. Regulatory authorities emphasized that unregistered medical devices must not be marketed and those who violate will bear legal responsibility.
• Operating Class III Medical Devices Without a License
  A workshop sold contact lenses on an e-commerce platform without a permit and was investigated for not having an operating license. Class III medical devices are high-risk products, and unlicensed operations will face severe penalties.

Interpretation of the "Medical Device Online Sales Quality Management Standards"

In April 2024, China's National Medical Products Administration (NMPA) officially released the "Medical Device Online Sales Quality Management Standards" (hereinafter referred to as the "Standards"), which will be fully implemented on October 1, 2025. As a regulatory document for online sales of medical devices, the core content of the regulations is analyzed from three aspects: scope of application, system requirements, and technological empowerment:

Extended Scope of Application

• Online Sellers
  Defined as enterprises selling medical devices through self-built websites, clients, or third-party platforms, including manufacturers, distributors, and import agents. Detailed Responsibilities:
  1. Qualification Display: The homepage must continuously display the “Medical Device Business License”, product registration certificate or filing certificate;
  2. Product Information Consistency: The name, scope of application, contraindications, etc., displayed on the page must be completely consistent with the registration certificate content;
  3. High-Risk Product Warning: Contact lenses, hearing aids, etc., need to be marked with mandatory prompts such as “professional fitting”.
• E-commerce Platform Operators
  Defined as third-party platforms providing transaction services for medical device transactions (such as B2B, B2C platforms). Detailed Responsibilities:
  1. Entry Review: Must conduct dual verification of merchant qualifications (licenses, filing certificates) and product registration information, and update files every 6 months;
  2. Real-Time Monitoring: Use technical means to dynamically monitor the information displayed by merchants on the platform, immediately remove and report to the drug regulatory department if violations are found;
  3. Data Preservation: Transaction records, payment information, logistics data, etc. need to be preserved for at least 5 years after the product's expiration date.

Dynamic Quality Management System: From "Formal Compliance" to "Full Process Control"

• Qualification Display and Information Management
  Mandatory Public Content:
  1. Business license or filing certificate (for Class II medical devices);
  2. Product registration certificate or filing information table (for Class I medical devices);
  3. After-sales service contact information and complaint handling process.
  Dynamic Update Requirements:
  1. Qualification information must be updated on the page within 3 working days after any change;
  2. High-risk products (such as Class III medical devices) need to set up an independent warning column, and the content must be completely consistent with the instructions.
• Data Traceability and Record Management
  Record Scope:
  1. Order number, logistics number, shipping date, receiving unit information;
  2. After-sales service records, customer complaint handling results.
  Preservation Requirements:
  1. All data must be preserved in electronic or paper form for at least 5 years after the product's expiration date, and support random retrieval;
  2. When entrusted transportation, the name of the carrier, waybill number, and transportation conditions must be recorded.
• Risk Prevention and Emergency Mechanism
  Risk Monitoring:
  1. Establish channels for collecting quality safety risk information, including regulatory department announcements, customer complaints, etc.;
  2. For suspected problem products, a suspension of sales and recall procedures must be initiated within 24 hours.
  Emergency Plan:
  1. Develop a response process for network security incidents to ensure recovery within 72 hours in case of data leakage or system failure;
  2. Conduct at least one full-chain risk drill each year and keep records.

Technological Empowerment for Compliance Management

• Application Scenarios for Digital Tools
  
  1. Automated Monitoring: Use AI algorithms to scan page information in real-time, automatically identify issues such as over-range promotion and expired qualifications. Blockchain technology is applied to preserve logistics data, ensuring records are tamper-proof.
  2. Intelligent Early Warning: Analyze customer complaint patterns using big data to identify potential quality risks in advance (Article 14, Article 15).
• Technological Compliance Boundaries
  
  1. Data Localization:
     • 🞂 All online sales data (including transaction records and user information) must be stored on servers located within China.
     • 🞂 Overseas cloud providers must partner with locally certified firms and may not transfer raw data across borders.
  2. System Functionality Requirements:
     • 🞂 Self-built websites or mobile apps must support data backup and system recovery capabilities.
     • 🞂 E-commerce platforms must implement a “one-click removal” function to immediately take down non-compliant listings.

Further Information

To read the original announcement about the enforcement actions related to illegal online sales of medical devices released by the NMPA on April 15, 2025, please refer to the NMPA news release. For detailed regulatory guidance, see the full text of the Medical Device Online Sales Quality Management Standards, which will take effect on October 1, 2025.

If you are a medical device manufacturer with questions about how long it takes or how much it costs to register your product for the China market, please contact Cisema.

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