Medical Device Regulation in China: A Complete Guide

A comparison of Medical Device Regulation between China and Thailand

Part 1: Overview of the Medical Device Regulation Framework

China’s regulatory landscape for medical device regulation is governed by a multi-tiered system of laws, administrative measures, and technical guidelines. At the core is the National Medical Products Administration (NMPA), operating under the State Administration for Market Regulation (SAMR).

The key legal instruments include:

• Regulations on the Supervision and Administration of Medical Devices (amended in 2024, effective January 2025)
• Measures for the Administration of Medical Device Registration (Decree No. 47)
• Good Clinical Practice (GCP) for Medical Devices (effective 2022)
• A suite of decrees covering production, usage, online sales, recalls, and advertising

China applies a risk-based classification similar to global standards:

• Class I: Low-risk devices – subject to record-filing (filing system)
• Class II: Moderate-risk devices – require product registration
• Class III: High-risk devices – subject to stringent registration and control

The regulatory structure emphasizes lifecycle management, product safety, and post-market surveillance.

Part 2: Documentation Requirements and Standards (Detailed)

1. Core Submission Documents

For Class II and III medical devices, the following are mandatory:

• Application form
• Product technical requirements: Functional and safety indicators, testing methods
• Risk analysis reports
• Clinical evaluation data
• Quality Management System (QMS) documents
• Instruction manuals and draft labels
• Registration inspection report
• Declaration of Conformity
• Biocompatibility, sterilization, animal testing, shelf life and packaging studies

2. Standards Framework

China aligns its standards with international norms while maintaining national identifiers:

Technical Area	Chinese Standard	International Equivalent
Quality Management Systems	YY/T 0287-2017	ISO 13485:2016
Risk Management	YY/T 0316-2016	ISO 14971:2016
Electrical Safety	GB 9706 series	IEC 60601
EMC	YY 0505-2012	IEC 60601-1-2
Biocompatibility	GB/T 16886 series	ISO 10993
Sterilization (EO)	GB 18279	ISO 11135
Cleanrooms	GB/T 25915	ISO 14644

These standards are binding for product testing, design validation, and manufacturing process verification.

3. Clinical Evaluation and Trials

• Class I: Generally exempt from clinical trials
• Class II and III: Must submit clinical evaluation reports; trials may be required
• Good Clinical Practice (GCP) guidelines** emphasize:
  • Ethics compliance (Helsinki Declaration)
  • Full protocol approval by Ethics Committee
  • Timely reporting of adverse events (within 5 days for severe cases)

Preclinical data must support clinical justification, including:

• Product mechanism and intended use
• Risk-benefit assessment
• Manufacturing controls
• Animal test results (if applicable)

Part 3: The Registration Process

1. Filing vs. Registration

Process	Applicable Class	Authority	Validity
Filing	Class I	Local market bureau	No expiry
Registration	Class II & III	Provincial (II) / NMPA (III)	5 years

2. Step-by-Step Registration Workflow

1. Preparation Phase
   • Internal QMS review and validation (min. 3 months)
   • Type inspection by authorized labs
   • Clinical evaluation path determination
2. Submission Phase
   • Online pre-application via eRPS system
   • Technical dossier compilation
   • Submission of materials in Chinese (foreign docs must include originals)
3. Review and Approval
   • Technical review: 90 days
   • Administrative review: 20 days
   • Supplementation (if required): Within 1 year
   • Registration certificate issued upon approval
4. Post-Approval
   • Registrants are legally liable for safety and effectiveness
   • Any significant changes (design, materials, scope) require re-registration
   • Renewals must be submitted 6 months before expiry

Conclusion: Medical Device Regulation China vs. Thailand – A Comparative View

Element	China	Thailand
Regulatory Authority	NMPA (centralized)	Thai FDA (under Ministry of Public Health)
Classification System	Class I, II, III (risk-based)	Class 1-4 (risk-based, with special sub-classes)
Filing vs. Registration	Class I = Filing; Class II & III = Registration	Class 1 = Notification; Class 2-4 = Licensing
Documentation Language	Chinese only (foreign must attach originals)	English/Thai accepted
Local Testing Requirement	Yes (for registration inspection)	Often required (depending on class & category)
Clinical Evaluation	Mandatory for Class II & III	Required for Class 3-4 and some Class 2
Validity Period	5 years	5 years
Renewal Timeline	Apply 6 months before expiry	Apply 180 days before expiry
Electronic Platform	eRPS	e-Submission (developing)

While both countries follow a risk-based model and aim to harmonize with ISO standards, China imposes stricter data localization (language and testing), centralized decision-making (NMPA), and detailed submission formats. Thailand, in contrast, provides more flexibility in documentation language and often faster pathways for low-risk products.

Siam Trade Development is committed to bridging the cultural and regulatory gaps between Thailand and China. We are continuously exploring solutions to ensure smooth and compliant regulatory exchanges between the two countries.

Our next initiative will be a presentation titled “Regulatory Roadmap to Success: Your Guide to Thai FDA Registration and Market Entry”, which our Director, Diego Sala, will deliver as keynote speaker at the Suzhou International Innovation in Medicine (SIIM), held at the Suzhou International Expo Center from August 26 to 28, 2025.

See you there!