Registering Medical Devices in China

China sorts medical devices into three classes by risk, from lowest to highest: Class I, Class II and Class III. The class depends on the device's intended purpose, and is judged together with its structural features, how it is used, its state of use and whether it contacts the body. This comes from Article 4 of the Medical Device Classification Rules (CFDA Order No. 15, issued 14 July 2015, in force since 1 January 2016). In practice, you find the class by looking the product up in NMPA's classification catalogues. Products the catalogues don't cover go through a formal classification determination procedure (分类界定).

Approach: RegAffairs AI doesn't hold China's device classification rules, so this answer comes from the Rules as published on gov.cn and from a 2024 guide by the Beijing Medical Products Administration. NMPA's own website wouldn't open this time, so I couldn't read its 2017 Classification Catalogue notice or its recent notices on changes to the Catalogue.

1. How the Rules are used

• Purpose (Art. 2): the Rules guide how NMPA drafts the classification catalogue and how it assigns a class to new devices.
• Definitions (Art. 3): key terms are defined, such as intended purpose, passive and active devices, invasive and implantable devices, and reusable surgical instruments.
• Dimensions (Art. 5): a device is classified by:
  • structure: passive or active
  • whether it contacts the human body
  • form of use
  • state of use, or how much harm follows if it fails

2. The classification decision table (Annex)

The Annex is a grid. Its rows are four device groups:

• passive, contacting the body
• passive, not contacting the body
• active, contacting the body
• active, not contacting the body

Its columns cover the state of use, the body site contacted, or the impact if control of the device is lost. Each cell gives I, II or III, or "–" where the case cannot occur.

3. Special rules that override the table (Art. 6)

Clause	Rule
(1)	A device that fits several categories takes the highest class
(2)	An accessory is classed by its effect on the main device
(3)	A device that monitors or controls another device takes that device's class
(4)	Drug-device combinations: Class III
(5)	Absorbable devices: Class III
(6)	Active contact devices with a major effect on treatment: Class III
(7)	Certain dressings: Class III (absorbable, contacting the deep dermis, for chronic wounds, or preventing tissue or organ adhesion)
(8)	Devices supplied sterile: at least Class II
(9)	Active orthopaedic (orthotic) devices: at least Class II
(10)	Devices with a measuring or testing function: at least Class II
(11)	Devices clearly intended to treat disease: at least Class II
(12)	Reusable surgical instruments used through an endoscope: Class II

• IVD reagents (Art. 7): these are classified under their own rules, not these ones.
• Changes to classes (Arts. 8 and 9): NMPA reviews changing risk and updates the catalogue, and may use an expert committee to draft and change it.

4. Catalogues to check

According to the Beijing guide, classification decisions are based on:

• the Classification Rules
• the Medical Device Classification Catalogue
• the IVD Classification Rules and IVD Classification Catalogue
• the Class I Medical Device Product Catalogue

5. When the class is unclear: classification determination (分类界定)

The Beijing guide says this procedure is used for new products, or where a product's class needs official confirmation before registration or filing.

• Where to apply: to the National Institute for Food and Drug Control (中检院), through its Medical Device Classification Determination Information System. Since 19 February 2024 the whole application has been electronic.
• What to submit:
  • a classification determination application form signed by the legal representative
  • technical documents
  • product photos or videos
  • instructions for use
• New products: you also need a comparison with products already on the market, and evidence that the product is new.
• NMPA announcements the guide cites: 2020 No. 147, 2022 No. 25, 2022 No. 30 and 2023 No. 101.

The class you end up with sets the route covered in my last answer: Class I filing, Class II registration with the provincial office, and Class III or imported Class II registration with NMPA.

Sources:

• Medical Device Classification Rules (CFDA Order No. 15), gov.cn
• 医疗器械分类界定一本通 (2024), Beijing Medical Products Administration

For Class II and III devices, the registration dossier has to contain seven things set by SAMR Order No. 47, Art. 52: product risk analysis, product technical requirements, a product test report, clinical evaluation data, draft instructions for use and labels, quality management system documents for development and production, and any other data needed to show the device is safe and effective. NMPA Announcement 2021 No. 121 (issued 30 September 2021, in force since 1 January 2022) turns this into a set format; its Annex 5 is the "Medical Device Registration Dossier Requirements and Explanations".

Approach: RegAffairs AI doesn't hold China's device registration rules yet, so I used official government pages. NMPA's own Annex 5 file wouldn't open from NMPA, Beijing or Shanghai, so the item-level detail below comes from the Beijing Medical Products Administration's Class II first-registration annex, which uses the NMPA module structure.

1. The legal minimum (Order No. 47)

• Art. 52: the seven items listed above.
• Art. 26, technical requirements: you write these yourself. They mainly cover the finished device's functional and safety indicators that can be judged objectively, plus the test methods.
• Arts. 30 and 32, test report: the device is tested against your technical requirements. The report can be your own self-test or one from a qualified device testing laboratory.
• Art. 18, imported devices: you add proof that the authority in your home or manufacturing country allows the device to be sold.
• Art. 14, agent: a foreign applicant files through its appointed Chinese legal-entity agent.

2. How the dossier is organised (Beijing Class II first registration, Annex 2)

No.	Module	What it contains
1-3	Application form; applicant's business licence; contract manufacturer's licence (if any)	Administrative documents
4	Monitoring information (监管信息), 4.1-4.6	Table of contents; list of terms and abbreviations; product list; associated documents; record of pre-submission contact with regulators; declaration of conformity
5	Summary (综述资料), 5.1-5.6	Overview; product description; scope of use and contraindications; marketing history; other information
6	Non-clinical data (非临床资料), 6.1-6.8	See section 3 below
7	Clinical evaluation (临床评价资料), 7.1-7.3	See section 4 below
8	Instructions for use and draft labels, 8.1-8.4	IFU that meets the Provisions for Medical Device Instructions and Labels; draft label for the smallest sales unit
9	QMS documents (质量管理体系文件), 9.1-9.10	See section 5 below
10	Letter of authorisation

The dossier must open with a table of contents that shows both first- and second-level headings.

3. Non-clinical data (module 6)

• Risk management: risk analysis, risk evaluation, risk control, acceptability of residual risk, and an overall risk-benefit judgement. Every hazard identified must be traceable through these steps.
• Essential principles checklist: how the device meets each safety and performance principle, and which documents show it. Explain why any principle doesn't apply.
• Technical requirements and test report: compliance with the mandatory standards that apply, the technical requirements themselves, and the test report.
• Research data, as relevant to the device:
  • chemical and physical performance
  • electrical safety
  • radiation safety
  • software
  • biological properties
  • safety of materials of biological origin
  • cleaning, disinfection and sterilisation
  • animal studies
  • other studies
• Stability: shelf life with packaging studies; stability and reliability in use; stability in transport.

4. Clinical evaluation (module 7)

• Background: product description and why it was developed, including current diagnostic or treatment options.
• Scope: which parts of the device are exempt from clinical evaluation.
• Route chosen: equivalent device, clinical trial, or both.
• Equivalence route: comparison data, then collection, appraisal and analysis of clinical data.
• Trial route: protocol, ethics committee opinion, trial report, sample informed-consent form and the trial database.

5. QMS documents (module 9)

• Commitment: a statement that you have set up a QMS that meets the regulations and will accept inspection at any time.
• Manufacturing information: how the device works, the overall production process, production sites and key suppliers.
• Procedures: the QMS itself, management responsibility, resource management, product realisation, and measurement, analysis and improvement.
• Inspection file:
  • applicant information form
  • organisation chart
  • site plan and layout of production areas
  • environmental monitoring report (if needed)
  • process flow chart
  • lists of main production and testing equipment
  • QMS self-inspection report

Announcement 121 has separate annexes for renewal (Annex 6), change filing or change registration (Annex 7) and clinical-trial approval (Annex 8). It also has its own essential principles checklist (Annex 9). In vitro diagnostic reagents use a different structure.

Sources:

• SAMR Order No. 47, Medical Device Registration and Filing Measures, gov.cn
• NMPA Announcement 2021 No. 121 (Beijing Municipal Government copy)
• NMPA Announcement 2021 No. 121 (Xinjiang MPA copy, with annex links)
• Beijing MPA Notice 〔2021〕 No. 4, Class II device and IVD registration dossier requirements