China Medical Device Registration – Overview

China is one of the world’s fastest‑expanding medical device markets, with a significant share of demand fulfilled through imported products. To enter the Chinese market, manufacturers must comply with regulatory requirements defined by the National Medical Products Administration (NMPA) formerly the CFDA and the Center for Medical Device Evaluation (CMDE).

All imported medical devices Class I, Class II, and Class III must go through the appropriate NMPA review and registration pathway. Overseas manufacturers must also appoint a local NMPA Legal Agent, who acts as the official in‑country representative for all regulatory communications and submissions.

China Regulatory Essentials

Regulatory Authority:

National Medical Products Administration (NMPA)

Primary Regulation:

State Council Order No. 739

Authorized Representative Requirement:

NMPA Legal Agent is mandatory for all foreign applicants

QMS Requirements:

  • YY/T 0287‑2017 (Chinese adaptation of ISO 13485)
  • ISO 13485:2016 (Global QMS standard)

Technical Review Body:

Center for Medical Device Evaluation (CMDE)

Labeling Requirements:

CFDA Decree No. 6

Submission Format:

eRPS electronic submission system

Submission Language:

English & Chinese

China Medical Device Classification

In China, medical devices are classified according to the Medical Device Classification Catalogue (NMPA Announcement No. 104/2017) and Order No. 15 classification rules.

Class Risk Level
Class I Low Risk
Class II Medium Risk
Class III High Risk

NMPA Legal Agent Services

Foreign manufacturers without a Chinese office must appoint a China Authorized Representative (CAR), also referred to as an NMPA Legal Agent. This representative:
  • Manages device registration activities
  • Communicates with NMPA on behalf of the manufacturer
  • Oversees regulatory submissions and updates
  • Ensures correct maintenance of registration documentation

The registration license is always owned by the manufacturer; however, the NMPA Legal Agent’s name appears on the certificate.

China Medical Device Registration Pathway

Class I Devices

  • Undergo administrative filing (record filing)
  • Faster review
  • Minimal technical testing

Class II & III Devices

  • Require detailed technical review
  • Submission must include product testing, safety & performance data
  • Predicate device identification may be required to determine the need for clinical evaluation
  • NMPA issues:
    • Record Filing Certificate (Class I)
    • Registration Certificate (Class II & III)

Registration Process (Simplified Flow)

If you want, I can create this as a diagram or flowchart:
  1. Determine device classification
  2. Appoint NMPA Legal Agent
  3. Conduct type testing in NMPA‑designated labs
  4. Prepare application dossier
  5. Submit registration via eRPS
  6. CMDE technical review
  7. Administrative approval
  8. Issuance of certificate

Post‑Approval Device Lifecycle Management

Masuu Global Solutions supports manufacturers in all post‑market activities, including:
  • Managing device changes (variants, accessories, expanded indications)
  • Renewal of licenses (every 5 years for Class II & III)
  • Payment of administrative and renewal fees
  • Communication and coordination with NMPA
  • Importation oversight and logistics compliance
With deep knowledge of NMPA requirements, Masuu simplifies clinical data preparation, testing pathways, and documentation preparation to accelerate Chinese market entry.

Registration Summary

Class Pathway Review Type Timeline Registration Validity
Class I Notification Administrative ~1 day Unlimited
Class II Registration Full Review 1–2 years 5 years
Class III Registration Full Review 2+ years 5 years

Masuu Global Solutions – China Regulatory Expertise

We provide full-spectrum support for China NMPA compliance, including:
  • Regulatory due diligence and market entry assessment
  • Regulatory Intelligence (RI) and ongoing updates
  • Product and manufacturing license support
  • In‑country product testing (clinical & non‑clinical)
  • Clinical Evaluation Reports (CER) aligned with NMPA expectations
  • QMS compliance alignment with YY/T0287 & ISO 13485
  • Compilation of registration dossiers & Good Regulatory Practice (GRP) documents
  • Labeling review and localization
  • Professional translation services (English ↔ Chinese)
  • Full submission management and NMPA communication
  • In‑country representation as NMPA Legal Agent
  • Distributor identification & qualification support
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