What is NMPA Order No. 47 and what does it regulate?

NMPA Order No. 47 is China's comprehensive regulation governing medical device registration and filing procedures, effective October 1, 2021. It establishes the legal framework for bringing medical devices to market in China.

What is the difference between registration and filing procedures in China?

Registration requires formal NMPA review and approval with technical evaluation (Class II-III devices). Filing is a simplified submission process where materials are archived without pre-approval (Class I devices).

Which authorities administer device registration and filing in China?

NMPA (national level) handles Class III domestic and Class II-III imported devices. Provincial authorities handle Class II domestic devices. Municipal authorities handle Class I device filing.

How are medical devices classified in China?

China uses a three-tier risk-based classification: Class I (low risk), Class II (moderate risk), and Class III (high risk). Classification follows the Medical Device Classification Rules and Catalogue.

What happens if a device's classification changes?

If classification increases to higher risk: New registration required by deadline NMPA specifies. If classification decreases to lower risk: Existing certificate remains valid until expiration, then follow new pathway for renewal.

What is the complete medical device registration process in China?

Registration process: (1) Complete product development and testing, (2) Prepare quality system, (3) Conduct clinical evaluation/trials, (4) Submit registration application, (5) Technical review (60-90 days), (6) Quality system inspection, (7) NMPA approval and certificate issuance.

What documentation is required for device registration or filing?

Core documents required: (1) Product risk analysis, (2) Product technical requirements, (3) Testing reports, (4) Clinical evaluation materials, (5) Instructions for use and labeling, (6) Quality system documentation, (7) Safety and effectiveness supporting data.

How long is a medical device registration certificate valid?

Medical device registration certificates are valid for 5 years from date of issuance. Renewal applications must be submitted 6 months before expiration to maintain continuous market authorization.

When is clinical evaluation or clinical trial required?

Clinical evaluation is required for all registrations except exempt Class I-II devices. Clinical trials are mandatory when: (1) Class III device poses high risk to humans, (2) Existing clinical data insufficient to confirm safety/effectiveness, or (3) NMPA determines trial necessary.

What is the process for conducting clinical trials in China?

Clinical trial process: (1) NMPA approval application (for high-risk devices), (2) Ethics committee approval, (3) Trial site preparation at qualified hospitals, (4) Filing with provincial authorities, (5) Trial conduct per GCP, (6) Adverse event reporting, (7) Final report submission.

What are the quality management system inspection requirements?

QMS inspection required during registration review for Class II-III devices. Provincial authorities conduct on-site inspection verifying GMP compliance, design controls, production management, and product-specific quality measures. Inspection completed within 30 days of notification.

What are the requirements for foreign manufacturers to register devices in China?

Foreign manufacturers must: (1) Designate a Chinese legal entity as their agent, (2) Provide marketing authorization from country of origin/manufacture, (3) Submit free sales certificate, (4) Authorize agent in writing with notarization. Agent assumes legal compliance responsibility.

What is the registration pathway difference for imported devices?

Imported device pathway: Class I filing with NMPA (national level). Class II-III registration with NMPA (not provincial). Same technical requirements as domestic but additional foreign manufacturer documentation required. QMS inspection conducted at foreign facility.

What is the innovative device registration pathway?

Innovative devices with core technology patents, domestic-first mechanisms, and significant clinical value can apply for special registration procedures. Benefits include: dedicated review team, expedited timelines, pre-submission meetings, and priority technical support throughout registration.

What are the priority and emergency registration pathways?

Priority pathway for: rare disease/cancer treatment devices, pediatric devices, clinically urgent unmet needs, or national strategic projects - provides expedited review and quality system inspection. Emergency pathway for public health events enables parallel review and accelerated approval.

What is conditional approval and when is it granted?

Conditional approval may be granted for devices treating rare diseases, life-threatening conditions with no effective treatment, or urgent public health needs. Approval includes mandatory post-market research requirements with specific completion timelines. Failure to complete can result in certificate cancellation.

NMPA Order No. 47 FAQ - Updated October 2025

China Medical Device Registration and Filing Management Measures. Expert guidance by Pure Global regulatory specialists

NMPA Regulation

Effective Oct 1, 2021

Replaces 2014 Version

Official Document

Access the official document:Download NMPA Order No. 47 (Chinese)

NMPA Registration Support from Pure Global

Navigate China's complex medical device registration system with confidence. Our China team provides end-to-end NMPA compliance support with local expertise.

Pure Global operates a dedicated Chinese subsidiary with regulatory experts who understand both NMPA requirements and international quality standards. We handle everything from classification determination to post-market surveillance.

Chinese Agent Services

Official NMPA-registered agent providing complete legal representation and regulatory liaison in China

Registration & Filing Management

Complete dossier preparation, NMPA submission, and approval process management for all device classes

Clinical Trial Coordination

Design, approval, and execution of NMPA-compliant clinical trials at qualified Chinese medical institutions

Quality System Inspection

GMP compliance assessment and preparation for NMPA quality management system audits

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Regulation Type

Registration & Filing

Dual pathway system based on device risk classification

Effective Date

Oct 1, 2021

Replaced previous 2014 registration measures

Registration Validity

5 Years

Medical device registration certificates valid for 5 years

Review Timeline

60-90 Days

Technical review period depending on device class

Frequently Asked Questions

On This Page

General Overview & Scope

Classification & Risk Management

Registration vs Filing Requirements

Clinical Evaluation & Trials

Quality System Requirements

International Manufacturer Requirements

Special Registration Procedures

Quick Resources

All China Regulations Pure Global China Services

Key Dates & Milestones

PublishedAug 26, 2021

EffectiveOct 1, 2021

Replaces2014 Version

Registration Checklist

Determine device classification (I/II/III)
Designate qualified Chinese agent (for imports)
Complete product technical requirements
Conduct testing at NMPA-recognized lab
Establish quality management system
Complete clinical evaluation/trials
Prepare Chinese labeling and IFU
Submit registration via NMPA portal

Key Review Timelines

Technical Review

Class II: 60 days
Class III: 90 days

Supplementary Materials

40-60 days after submission

QMS Inspection

30 days completion target

Final Decision

20 days after review completion

Certificate Issuance

10 days after approval

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Note: This FAQ guide provides general information about regulatory requirements and should not be considered as legal advice. Regulations are subject to change. Always consult with qualified regulatory professionals for specific guidance.

Last updated: October 2025 | Based on NMPA Order No. 47 official documentation