Unlock China’s Online Medical Device Market: Your Compliance Roadmap

Original regulation


Introduction


China’s $30B+ medical device e-commerce market is exploding, but stricter 2025 regulations demand precision compliance. At EasychinaApprov, we help global brands navigate these rules to sell online safely. Here’s what you must know:


 

5 Critical Compliance Pillars for Online Medical Device Sales


1. Licensing & Documentation: Non-Negotiable Displays

  • Boldly showcase licenses on your homepage & product pages:
  • Business licenses/filing certificates (Art. 11).
  • Medical device registration/filing numbers (Art. 12).
  • Product warnings must be visible (e.g., "Hearing aids require professional fitting") (Art. 12).
  • All displayed info must match regulatory documents exactly – zero deviations (Art. 13).


2. Infrastructure: Tech Controls Inside China

  • Servers must be China-based (Art. 9).
  • Systems need backup/failover capabilities + cybersecurity incident plans (Art. 9).
  • E-commerce platforms must verify seller qualifications in real-time (Art. 23).


3. Quality Management System (QMS): Beyond Basics

  • Appoint dedicated online sales QA personnel (Art. 6).
  • Dynamic monitoring of all displayed content – remove non-compliant info instantly (Art. 14).
  • Include these in your QMS (Art. 10):
  • Online sales data tracking.
  • Risk control protocols.
  • Platform qualification audits.

4. Logistics & Record-Keeping: Trace or Face Penalties

  • Track every sale with online order numbers (Art. 16).
  • Transportation records must include:
  • Device specs + batch numbers (Art. 19).
  • Shipping conditions (aligned with product requirements) (Art. 18).
  • Wholesalers: Verify buyer qualifications (Art. 15).


5. Post-Sale Obligations: Transparency is Key

  • Display after-sales contact info prominently (Art. 20).
  • Monitor regulatory alerts – suspend sales if risks arise (Art. 21).
  • Annual self-inspections must cover online operations (Art. 22).

 

Where Foreign Brands Fail

  • ❌ Hidden licenses: Buried links or outdated certificates.
  • ❌ Offshore data storage: Violates Art. 9.
  • ❌ Static monitoring: Infrequent checks for policy changes.

 

How EasychinaApprov Ensures Your Success


We handle complexity so you focus on sales:

  1. Distributor for online sales: search of perfect compliant distributor.
  2. Outsourced regulatory role: Registration and PMS in name of your distributor
  3. Establishment of sales channel: support to establish typical and online channel
  4. Audit Shield: audit your Chinese distributor for online sales


Annex: Key Points from NMPA’s Guiding Principles for On-site Inspection of Quality Management in Online Sales of Medical Devices


To support consistent enforcement from Oct, 1 2025, the NMPA released a detailed inspection manual guiding provincial authorities on how to evaluate compliance of online medical device sellers and e-commerce platforms.


1. Quality Management & Organization

·        Online sellers must establish a quality department or assign qualified personnel responsible for network sales.

·        Inspectors will check whether quality staff are properly appointed and trained, and whether their duties cover risk control, complaint handling, and product information review.

·        For wholesale (Class II & III devices), seller must verify buyer qualifications and maintain updated records.


2. Information Display & Traceability

·        Inspectors will confirm that licenses and registration certificates are displayed on homepages and product pages, and that product information exactly matches the NMPA database.

·        Warning statements must be shown for products requiring professional fitting (e.g., contact lenses, hearing aids).

·        All online records—including orders, delivery, and transport—must be traceable, accurate, and securely stored.


3. IT Systems & Data Security

·        Data servers must be located inside China.

·        Systems must have backup, disaster recovery, and network security plans.

·        For self-built websites or apps, operators must perform periodic system testing to ensure reliability.


4. E-Commerce Platform Duties

·        Platforms (e.g., JD Health, Tmall, Pinduoduo) must verify and archive seller qualifications, monitor listings, and immediately stop non-compliant sales.

·        They must assign a Quality and Safety Manager with decision-making authority and conduct quarterly safety meetings.

·        Platforms should maintain records of seller inspections, product risk monitoring, and complaint resolution.



5. Continuous Supervision & Self-Inspection

·        Companies must submit annual self-inspection reports covering online sales quality management by March 31 each year.

·        Inspectors will review the company’s records on complaint handling, transport conditions, and IT safety measures