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NMPA · East Asia & Pacific

China medical device regulatory resources

Every China dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

149,652 registration records12 free resources24/25 requirements covered5 regulations trackedAug 2026 fees reviewed

Everything we track for China

Structured regulatory requirements

Explore all 40 source-linked facts

24 of 25 research dimensions currently covered · 22 official sources · latest verification 2026-08-30

Market entry

D01

Authority & regime

Verified
Competent authority
The National Medical Products Administration (NMPA, 国务院药品监督管理部门) is responsible for supervision and administration of medical devices nationwide.
Tiered administration levels
Device regulation is exercised at three administrative levels: NMPA (national), provincial drug regulatory departments, and municipal (prefecture level, 设区的市级) departments. For example, dom…
2 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Primary legislation and effective date
Primary legislation: Regulations on the Supervision and Administration of Medical Devices (医疗器械监督管理条例), State Council Decree No. 739, in force since 2021 06 01.
1 source-linked fact
Checked 2026-08-25
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D03

Device definition & scope

Verified
Statutory device definition
A medical device is any instrument, apparatus, implement, in vitro diagnostic reagent or calibrator, material or other similar or related item used directly or indirectly on the human body,…
1 source-linked fact
Checked 2026-08-25
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D04

Classification rules

Verified
Risk classes I through III.
Class I, Class II, Class III
1 maintained scheme
Checked 2026-08-13
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D05

Registration pathways

Verified
Filing vs registration route split
Class I devices are subject to product filing (备案); Class II and Class III devices are subject to product registration (注册) with acceptance, technical review and administrative decision.
Registration authority by class and origin
Domestic Class II registration is reviewed and approved by provincial drug regulatory departments; domestic Class III and all imported devices (Class I filing and Class II/III registration)…
2 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
Home-country marketing certificate as eligibility gate
For import Class II/III registration the designated China agent submits, together with the application dossier, the marketing approval certificate issued by the regulator of the registrant'…
Innovative-device exemption from home-market certificate
Innovative medical devices not yet marketed outside China need not submit the home country/region marketing approval certificate in the import filing/registration.
2 source-linked facts
Checked 2026-08-25
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D07

Economic-operator roles

Verified
Mandatory China agent for overseas registrant
An overseas registrant exporting Class II/III devices to China must designate a Chinese legal person enterprise (我国境内企业法人, the China agent) that submits the registration application to NMPA…
China agent post-market duties
The China agent designated by an overseas holder must carry out adverse event monitoring for the imported devices sold in China and cooperate with the overseas holder in re evaluation oblig…
2 source-linked facts
Checked 2026-08-26
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D08

Establishment, import & distribution

Verified
Production license for Class II/III manufacturing
Manufacturing Class II or III devices requires a production license (生产许可) applied for from the provincial drug regulatory department, supported by evidence of GMP compliance and the device…
Distribution filing and license by class
Distribution controls are tiered: operating Class II devices requires filing (备案) with the municipal drug regulatory department; operating Class III devices requires an operation license (经…
2 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Mandatory dossier requirements and document formats
NMPA Announcement No. 121 of 2021 prescribes the mandatory registration dossier requirements and the certificate/decision document formats, with separate annexes for first registration, cha…
1 source-linked fact
Checked 2026-08-25
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D10

Official forms & portals

Verified
NMPA government service portal as submission surface
Device licensing items are standardized and published on the NMPA government service portal (zwfw.nmpa.gov.cn) as 办事指南 items covering forms, materials, fees and statutory clocks; e.g. impor…
1 source-linked fact
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Chinese language for labels and IFU
Labels and IFUs must use Chinese, conforming to national language norms; other languages may be added, but the Chinese text prevails.
Imported-device label content and import gate
Imported devices must have a Chinese IFU and Chinese label; the IFU must state the country of origin and the name, address and contact details of the China legal person enterprise designate…
2 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Device GMP transition 2014 to 2025
The revised Medical Device GMP (医疗器械生产质量管理规范) takes effect 2026 11 01 and simultaneously repeals the 2014 GMP (CFDA Announcement No. 64 of 2014, in force since 2015 03 01). Until 2026 11 01…
QMS verification during registration
During registration review, the drug regulatory department organizes a quality management system verification (registration QMS check) when it considers one necessary.
2 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
NMPA electrical/EMC evidence
Electrical safety
SRRC radio transmission equipment type approval
Wireless / radio
CCC
Adapters / components
5 maintained overlays
Checked 2026-08-29
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Imported Class I filing
CNY 0
Imported Class II registration
CNY 210,900
11 maintained fee lines · 1 related fact
Checked 2026-08-25
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D15

Review clocks

Verified
Class I · Filing/Recordation (备案) — no review, no fee
0 days
Class II · Provincial Registration
4 months
Class III · NMPA Registration
5-6 months
3 maintained pathways · 2 related facts
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Registration certificate validity
The medical device registration certificate is valid for 5 years. Class I filing has no ordinary 5 year certificate.
Renewal application window
Renewal (延续注册) must be applied for with the original registering authority at least 6 months before the certificate expires.
3 source-linked facts
Checked 2026-08-26
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Lifecycle & post-market

D17

Change control

Verified
Substantive changes require change registration
Substantive changes to a registered Class II/III device (design, raw materials, production process, intended scope of use, method of use, etc.) that may affect safety or effectiveness requi…
Non-substantive changes filed within 30 days
Changes to a registered device other than those requiring change registration must be filed (备案) with the original registration authority within 30 days from the date of the change.
2 source-linked facts
Checked 2026-08-26
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D18

UDI, listing & traceability

Verified
UDI phased implementation batches
UDI is implemented in batches: from 2021 01 01 the first 9 categories / 69 types of Class III devices; from 2022 06 01 all other Class III devices including IVDs; from 2024 06 01 the third…
UDI full Class II and Class I coverage
Following implementation across all Class III devices (incl. IVDs) and 103 Class II device types, all Class II devices (including IVDs) and all Class I IVDs produced from 2027 06 01, and al…
3 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical evaluation routes and exemption
Registration/filing requires clinical evaluation unless a Decree Art. 24 exemption applies; evaluation may be satisfied either by a clinical trial or by analysis of clinical literature and…
Prior approval for high-risk Class III trials
Clinical trials of Class III devices presenting high risk to the human body require prior NMPA approval before the trial may proceed; the approval application is decided within 60 days with…
2 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
Conditional approval and emergency use
Devices for rare diseases, life threatening conditions without effective treatment, or public health emergencies may receive conditional approval (附条件批准) with the conditions recorded in the…
1 source-linked fact
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Registrant/holder lifecycle duties
Registrants/holders must: establish and maintain a functioning QMS suited to the product; formulate and effectively implement post market research and risk control plans; conduct adverse ev…
Annual periodic risk evaluation report
Holders must complete a periodic risk evaluation report (定期风险评价报告) for the previous year within 60 days after each anniversary of first approval/filing; NMPA registered products report to t…
2 source-linked facts
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Individual adverse-event reporting deadlines
Reporting follows the report if suspicious (可疑即报) principle: events that led or may lead to serious injury or death must be reported (innovative devices: all events in the first registratio…
Group adverse-event emergency reporting
Group (群体) adverse events must be reported within 12 hours by phone/fax to the provincial drug regulatory and health departments where the event occurred, with basic information entered in…
2 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
Holder-initiated recall duty
Where a registered/filed device fails mandatory standards or the registered product technical requirements, or has other defects, the registrant/holder must immediately stop production, not…
Recall levels and notification deadlines
Recalls are classified by hazard severity (Art. 13: Level 1 = possible/actual serious health harm; Level 2 = temporary or reversible harm; Level 3 = lower likelihood of harm but recall warr…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Pre-publication advertising approval
Medical device advertising must be reviewed before publication by the advertising review authority designated by the province, and an advertisement approval number obtained;未经审查,不得发布. Conte…
1 source-linked fact
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Appeal against approval conclusions
Applicants who disagree with an approval conclusion on NMPA licensing items may seek administrative reconsideration (行政复议) by NMPA or file administrative litigation (行政诉讼).
1 source-linked fact
Checked 2026-08-25
Open details →

NMPA registration fees in CNY · reviewed 2026-08-25

Fee lineAmountProvenance
Imported Class I filingCNY 0Verified
Imported Class II registrationCNY 210,900Verified
Imported Class II change registration (变更注册)CNY 42,000Verified
Imported Class II renewal registration (延续注册)CNY 40,800Verified
7 more fee lines on the full schedule · 11 of 11 rows source-verified

Registration timeline

Full registration timeline

National Medical Products Administration (NMPA) review clocks and planning ranges · 3-class (I, II, III) classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Filing/Recordation (备案) — no review, no fee)0 days2-4 monthsVerified
Class II(Provincial Registration)4 months1-1.5 yearsVerified
Class III(NMPA Registration)5-6 months2-3 yearsVerified
  1. 1Device Classification(2-4 weeks)
  2. 2In-Country Testing(3-6 months)
  3. 3Clinical Trial (if required)(12-24 months)
  4. 4Appoint Agent(2-4 weeks)
  5. 5NMPA Application(1-2 weeks)
  6. 6NMPA Review(12-18 months)
  7. 7Registration Certificate(2-4 weeks)

Latest regulation news

All China regulation news

Newest official NMPA headlines from the daily-refreshed feed — every row links directly to the authority publication.

Official NMPA rules and guidance · 5 of 5 documents linked to official sources

State Council Order No. 739Regulations on Supervision and Administration of Medical Devices
GeneralVerified
NMPA Official PortalNational Medical Products Administration - Medical Devices
GeneralVerified
SAMR Decree No. 47Provisions for Medical Device Registration and Filing
RegistrationVerified
Classification RulesRules for Classification of Medical Devices
ClassificationVerified

Computed from 149,652 official NMPA registration records · data as of 2025-02-09

New registrations by year
2019202020212022202320242025
VerifiedNMPA registry · as of 2025-02-09
149,652
Registrations
24,000
Registrants
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