Selling medical devices online in China is legal for foreign-invested businesses, but it requires up to three layers of compliance: an operating licence or filing under the 2022 rules, a separate online-sales information filing with the municipal regulator, and — for your own website — an Internet Drug Information Services Certificate. Class III licences are decided within 20 working days.
Quick Facts
| Metric | Value |
|---|---|
| Governing online-sales rule | Measures on Supervision of Online Sales of Medical Devices, effective 1 March 2018 (Decree No. 38) |
| Governing operating rule | Measures on Supervision of Medical Device Operations (Decree No. 54), effective 1 May 2022 |
| Class III operating licence decision time | 20 working days from acceptance (2022 rules) |
| Class II operating filing | Instant document check; on-site inspection within 3 months of filing (2022) |
| Operating licence validity | 5 years, electronic certificate equal legal effect (2022) |
| Online-sales information filing authority | Municipal-level (city with districts) medical products regulator (2018 rule) |
| Third-party platform filing authority | Provincial-level medical products regulator (2018 rule) |
| Government fee for online-sales information filing | 0 RMB in most regions (2026) |
| 2026 revision status | Draft revision of the online-sales measures open for public comment 27 July – 26 August 2026 |
What Qualifies as "Online Sales" and Who Must File?
If you display a device for sale on a website, app or platform and complete the transaction online, you are conducting online sales and must hold the underlying operating qualification plus an online-sales information filing. The rules distinguish sellers from platforms: a platform only provides web space, virtual trading venues, trading rules, matchmaking and electronic orders without directly selling (Measures on Supervision of Online Sales of Medical Devices (Decree No. 38)).
You must already be a licensed manufacturer, a licensed distributor, or a filed distributor before you can sell online. The only exception is a registration certificate holder selling its own products, or an authorised online seller acting for a holder (Decree No. 38, Article 7). This holder-self-sale carve-out dates from the marketing-authorisation-holder system introduced after 2014 — it does not mean all online sales are filing-free.
Which Operating Licence or Filing Do I Need? Class I, II, III Compared
China grades device operations by risk. Class I devices require no licence and no filing. Class II requires an operating filing (bei'an) with the municipal regulator. Class III requires an operating licence (xukezheng) (Shenzhen Market Regulation Bureau guidance). Some Class II products whose safety and effectiveness are unaffected by circulation may be exempt from the filing requirement.
| Class | Requirement | Authority | Timeline | Validity |
|---|---|---|---|---|
| Class I | No licence, no filing | — | — | — |
| Class II | Operating filing (bei'an) | Municipal regulator | Instant document check; on-site inspection within 3 months | Filing record, no fixed expiry |
| Class III | Operating licence (xukezheng) | Municipal regulator | Decision within 20 working days of acceptance | 5 years |
The 2022 rules introduced two practical improvements. First, Class II filings are now checked instantly against submitted documents, with the on-site inspection moved to within 3 months after filing rather than before. Second, if you need both a Class III licence and a Class II filing, you can submit one set of materials and complete a single combined on-site inspection (Measures on Supervision of Medical Device Operations (Decree No. 54)).
What Does the Online-Sales Information Filing Involve?
This is a separate filing from your operating licence — a common point of confusion. You submit an online-sales information form to the municipal-level regulator where you are located, covering your company name, legal representative and principal responsible person, website name, app name, domain name, IP address, telecom licence or ICP filing number, and your operating licence or filing certificate number (Decree No. 38, Article 8).
There is no officially fixed processing period for this information filing; in practice it is often completed within a few working days. Government fees are 0 RMB in most regions, though some localities may charge a nominal certificate fee — check with your local authority. Sample filing numbers follow formats like "(Jing) Wangxie Platform Bei Zi (2022) No. 00019" for platforms or regional equivalents for sellers (Benxi Market Regulation Bureau sample notices).
Do I Need Extra Qualifications to Sell on My Own Website?
Yes. If you sell through your own website rather than an established platform, you additionally need an Internet Drug Information Services Certificate and must demonstrate data backup and failure-recovery technical capabilities (Decree No. 38, Article 9). Most foreign brands start on Tmall, JD or similar platforms precisely to avoid this layer.
What Must My Product Pages Display?
Chinese rules are strict about what appears on each product page. Your homepage must show your operating licence or filing certificate, and each product page must show the device's registration certificate or filing certificate number — written in text, not just an image. Any change to this information must be updated promptly (Decree No. 38, Article 10).
Product names, models, specifications, intended use, registration certificate numbers and registrant/filer information must match the registered or filed content exactly (Decree No. 38, Article 11). You also cannot sell beyond the scope of your operating licence or filing (Decree No. 38, Article 13).
What Records Must I Keep, and for How Long?
| Record type | Minimum retention |
|---|---|
| Products with a shelf life / expiry date | 2 years after expiry |
| Products with no expiry date | At least 5 years |
| Implantable devices | Permanently |
These retention rules apply to your sales records under the 2018 online-sales measures (Decree No. 38, Article 12). Your quality management system and information management system must support this level of traceability — regulators increasingly verify this through a national online-sales monitoring platform designed to make online sales traceable end-to-end (NMPA 2021 monitoring work meeting).
What If I Want to Run a Third-Party Platform?
If your business model is to host other sellers rather than sell directly, you file with the provincial-level regulator, not the municipal one — a different filing with different materials (Decree No. 38, Article 16). Nine categories of materials are required, including your business licence, identity documents, premises diagrams with property or lease proof, telecom licence or ICP filing, the Internet Drug Information Services Certificate, a quality management system catalogue, and website/app descriptions (Beijing government filing guide).
Step-by-Step: Setting Up Compliant Online Sales
- Confirm your device classification. Determine whether your product is Class I, II or III under China's classification catalogue — this drives every downstream requirement (Shenzhen guidance).
- Secure the product registration or filing. Your device must hold a valid NMPA registration certificate or filing certificate before any sales channel opens.
- Obtain the operating licence or filing. For Class III, prepare legal-representative and quality-responsible-person credentials, premises and warehouse diagrams, equipment lists and quality-system documents; expect a 20-working-day decision. For Class II, submit the filing and prepare for an on-site check within 3 months (Decree No. 54).
- Choose your channel and complete the online-sales information filing. Submit the information form to the municipal regulator with your domain, ICP number and licence number (Decree No. 38, Article 8).
- If self-hosting, add the Internet Drug Information Services Certificate. This is in addition to your normal ICP filing (Decree No. 38, Article 9).
- Build compliant product pages. Display certificates in text, match all content to the registration dossier, and set up record-keeping per the retention table above.
- Maintain and renew. Track the 5-year licence validity, update changes (premises, scope, warehouse: 20 working days; other items: instant), and monitor the 2026 revision process (Decree No. 54, Article 21).
What to Watch Out For
Two different filings, two different authorities. Sellers file online-sales information with the municipal regulator; platform operators file with the provincial regulator. Confusing these delays market entry by weeks (Decree No. 38).
The 2026 revision is pending. A draft revision of the online-sales measures was open for public comment from 27 July to 26 August 2026. As of October 2026 the 2018 rules remain in force, but final changes could adjust filing or display requirements (NMPA draft revision notice, 2026).
Loss of contact has consequences. If you become unreachable, regulators may cancel your licence or flag your filing, and your website can be referred to telecommunications authorities for blocking (Decree No. 38, Article 32).
Quality-system failures can suspend sales. If you fail to establish or implement a quality management system and a quality risk exists, regulators may suspend your online sales until you apply for reinstatement and pass inspection (Decree No. 38, Article 33).
Frequently Asked Questions
Q: Do I need a separate filing to sell medical devices online in China if I already have an operating licence?
A: Yes. The operating licence or filing covers your offline business; online sales require an additional information filing with the municipal-level regulator under the 2018 measures. The filing covers your website name, domain, IP address and ICP number, and typically costs 0 RMB in most regions.
Q: How long does a Class III medical device operating licence take in China?
A: The regulator must decide within 20 working days of accepting a complete application under the 2022 rules. The licence is valid for 5 years, and the electronic certificate carries the same legal effect as the paper version. Changes to premises, scope or warehouses need a fresh 20-working-day decision.
Q: Can a foreign company sell medical devices online in China without a local entity?
A: No. You must be an enterprise that has obtained production or operating licensing, or completed an operating filing, in China. The only exceptions are a registration certificate holder selling its own products or an authorised online seller acting for a holder — both require a Chinese-registered entity.
Q: What is the difference between the online-sales filing and the third-party platform filing?
A: They are two distinct filings. Sellers file an online-sales information form with the municipal-level regulator; platform operators that host other sellers file with the provincial-level regulator using nine categories of materials, including an Internet Drug Information Services Certificate. The authorities, materials and certificate formats all differ.
Q: Do I need an ICP licence to sell medical devices on my own Chinese website?
A: Yes. Your own website requires a telecom licence or ICP filing number, which must be listed in your online-sales information filing. Additionally, self-hosted medical device sales require an Internet Drug Information Services Certificate and demonstrable data backup and failure-recovery capabilities under Article 9 of the 2018 measures.
Q: How long must I keep sales records for medical devices sold online?
A: Products with an expiry date: keep records for 2 years after that date. Products with no expiry date: at least 5 years. Implantable devices: permanently. These retention periods come from Article 12 of the 2018 online-sales measures and apply to all online channels.
Q: Can I sell Class I medical devices online without any licence or filing?
A: Class I devices require no operating licence and no operating filing. However, you still need to complete the online-sales information filing with the municipal regulator before selling online, and your product must hold a valid registration or filing certificate. The online-sales layer applies regardless of device class.
Q: What happens if I sell outside the scope of my licence?
A: Selling beyond the scope of your production or operating licence or filing is expressly prohibited under Article 13 of the 2018 measures. Regulators may suspend your online sales if quality-management failures create risk, and repeated violations can lead to licence cancellation or referral to telecommunications authorities.
Q: Is the online-sales information filing free?
A: In most regions, yes — government fees are 0 RMB because the filing is an administrative record rather than a charged licence. A few localities may charge a small certificate fee. There is no officially fixed national processing period; in practice filings are often completed within a few working days.
Q: Are the rules changing in 2026?
A: A draft revision of the Measures on Supervision of Online Sales of Medical Devices was released for public comment from 27 July to 26 August 2026. As of October 2026, the 2018 rules remain in force. Final changes could affect filing, display or platform obligations, so monitor NMPA announcements before finalising your compliance plan.
Conclusion
- Three layers, not one. Selling medical devices online in China requires the underlying operating licence or filing, a separate online-sales information filing, and — for self-hosted sites — an Internet Drug Information Services Certificate.
- Timelines are now faster. Class III licences are decided within 20 working days; Class II filings are checked instantly with a 3-month follow-up inspection under the 2022 rules.
- The 2018 online-sales rules still govern, but revision is underway. A draft update was open for comment in mid-2026; the current framework remains binding as of October 2026.
For personalized guidance on your China e-commerce licensing pathway, contact the CnBusinessHub advisory team at consult@CnBusinessHub.com to book a consultation.
Written by the CnBusinessHub Advisory Team, China market-entry advisors since 2019 — 1,500+ foreign enterprises guided across 16+ cities.
Last updated: 2026-10-11 | Next review: April 2027
Sources
- Measures on Supervision of Online Sales of Medical Devices (Decree No. 38) — National Medical Products Administration
- Notice on Implementation of Decree No. 54 (2022 No. 18) — National Medical Products Administration
- Measures on Supervision of Medical Device Operations (Decree No. 54, draft for comment) — National Medical Products Administration
- Notice on Draft Revision of Online-Sales Measures (2026) — National Medical Products Administration
- Beijing Guide: Third-Party Platform Filing for Medical Device Online Trading Services — Beijing Municipal Government
- Shenzhen Guide: Medical Device Operating Licence and Filing — Shenzhen Market Regulation Bureau
- Shanghai: Third-Party Platform Filing Administrative Item — Shanghai Municipal Government
- Benxi Sample Notices: Online-Sales Information Filing and Changes — Benxi Market Regulation Bureau
- Online-Sales Monitoring Work Meeting (2021) — National Medical Products Administration
- Interpretation of Decree No. 38 (2017) — National Medical Products Administration
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