People's Republic of China Product Registration & Certification
Important Notes
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China Specific Requirements
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Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate (Registration) / Filing Certificate (Filing)
- Risk classification per "Medical Device Classification Catalog" and "Medical Device Classification Rules" (Class I, II, III)
- Complete technical documentation (Product technical requirements, research data, risk analysis)
- Quality Management System audit documents (per "Medical Device Good Manufacturing Practice")
- Chinese labeling and instructions compliant with "Medical Device Labeling and Instructions Regulations"
- Clinical evaluation data (Clinical trial reports or equivalent clinical evaluation reports)
- Product testing reports (issued by qualified medical device testing institutions)
- Authorization letter and qualification documents of Domestic Agent
- Legal production qualification documents of overseas manufacturer
- Research data on raw material sources, manufacturing process, quality control
- Stability study data and shelf-life determination basis
- Product registration standards or technical requirements
Main Process
- Product classification confirmation (per latest classification catalog)
- Domestic Agent qualification review and authorization
- Testing institution commission (full performance testing)
- Clinical evaluation protocol development and implementation
- Quality Management System document preparation and self-audit
- Registration dossier compilation (electronic submission)
- NMPA/Provincial Medical Products Administration technical review
- Quality Management System on-site audit
- Registration approval and certificate issuance
Registration Timeline
Class I Filing: 1-3 months
Class II Registration: 12-24 months
Class III Registration: 18-36 months
Innovative Medical Device: 6-12 months (Priority Review)
Official Fees
Class II First Registration: ¥63,400 - ¥126,800
Class III First Registration: ¥95,100 - ¥190,200
Change Registration: ¥21,100 - ¥84,600
Service Fees
Class I Filing: $8,000 - $15,000
Class II Registration: $25,000 - $60,000
Class III Registration: $50,000 - $150,000
Regulatory System Overview
NMPA
National Medical Products Administration
Under State Administration for Market Regulation, exercising authority under Drug Administration Law, Medical Device Regulations, Cosmetic Supervision Regulations, responsible for nationwide pre-market approval, quality management, post-market surveillance, and market regulation of drugs, medical devices, cosmetics.
SAMR
State Administration for Market Regulation
Directly under State Council, responsible for health food and special food registration/filing management, unified market comprehensive supervision, organizing and guiding market supervision comprehensive law enforcement, maintaining market order.
NIFDC
National Institutes for Food and Drug Control
Directly under NMPA, responsible for national supervision sampling, re-inspection, quality standard development/revision, testing technology research for drugs, medical devices, cosmetics, health foods, providing technical support for supervision.
CMDE
Center for Medical Device Evaluation, NMPA
Responsible for medical device registration technical review, organizing development of medical device technical review specifications, conducting medical device review-related technical support and services.
CDE
Center for Drug Evaluation, NMPA
Responsible for drug and cosmetic registration technical review, developing relevant technical review specifications, conducting drug and cosmetic review-related technical support and services.
Medical Devices Registration Process
Regulatory Classification & Pathway Determination
Determine product management category (Class I filing, Class II/III registration) per "Medical Device Classification Rules" and latest catalog, develop registration strategy
Domestic Agent Legal Authorization
Appoint qualified Chinese Domestic Agent, sign authorization agreement, establish legal responsibility framework compliant with "Medical Device Supervision Regulations"
Technical Documentation Preparation & Testing
Compile product technical requirements, commission qualified testing institutions for full performance testing, prepare research data and risk analysis reports
Clinical Evaluation Completion
Conduct clinical trials or equivalent clinical evaluation for Class II/III products, obtain ethics committee approval and clinical trial reports
Quality Management System Establishment
Prepare system documents compliant with "Medical Device Good Manufacturing Practice", undergo possible NMPA on-site audit
Registration Application Submission
Submit electronic application through NMPA Online Service Portal, pay registration fees
Technical Review & Approval
NMPA/Provincial Medical Products Administration conducts technical review (Class II: 60-90 working days, Class III: 90-180 working days), issues Medical Device Registration Certificate
Cosmetics Registration
Regulatory Requirements
- Cosmetic Registration Certificate (Special Cosmetics) / Filing Certificate (General Cosmetics)
- Product formula and ingredient safety information (compliant with "Cosmetic Safety Technical Specifications")
- Product Safety Assessment Report (issued by cosmetic registration/filing testing institutions or safety assessors)
- Product implementation standards (Enterprise standards or National standards)
- Good Manufacturing Practice compliance declaration
- Chinese labeling compliant with "Cosmetic Labeling Management Measures"
- Efficacy claim substantiation summary (per "Cosmetic Efficacy Claim Evaluation Specifications")
- Product testing reports (microbiological, physicochemical, toxicological tests)
- Authorization letter and qualification documents of Domestic Agent
- Product formula stability test data
- Manufacturing process and quality control documents
- Product safety assessment materials
Main Process
- Product classification confirmation (Special/General cosmetics)
- Domestic Agent qualification review and authorization
- Formula safety assessment and efficacy claim evaluation
- Filing testing institution commission
- Registration/Filing dossier compilation
- NMPA Filing Platform application submission
- Technical review and filing completion
- Post-market adverse reaction monitoring establishment
Registration Timeline
General Cosmetics Filing: 1-3 months
Special Cosmetics Registration: 6-18 months
New Ingredient Cosmetics: 12-24 months
Official Fees
General Cosmetics Filing: ¥0 (Free)
Special Cosmetics Registration: ¥9,000 - ¥18,000
Change/Continuation: ¥2,000 - ¥4,000
Service Fees
General Cosmetics Filing: $5,000 - $12,000
Special Cosmetics Registration: $15,000 - $40,000
Product Series Registration: $20,000 - $50,000
Regulatory System Overview
NMPA
National Medical Products Administration
Under State Administration for Market Regulation, exercising authority under Drug Administration Law, Medical Device Regulations, Cosmetic Supervision Regulations, responsible for nationwide pre-market approval, quality management, post-market surveillance, and market regulation of drugs, medical devices, cosmetics.
SAMR
State Administration for Market Regulation
Directly under State Council, responsible for health food and special food registration/filing management, unified market comprehensive supervision, organizing and guiding market supervision comprehensive law enforcement, maintaining market order.
NIFDC
National Institutes for Food and Drug Control
Directly under NMPA, responsible for national supervision sampling, re-inspection, quality standard development/revision, testing technology research for drugs, medical devices, cosmetics, health foods, providing technical support for supervision.
CMDE
Center for Medical Device Evaluation, NMPA
Responsible for medical device registration technical review, organizing development of medical device technical review specifications, conducting medical device review-related technical support and services.
CDE
Center for Drug Evaluation, NMPA
Responsible for drug and cosmetic registration technical review, developing relevant technical review specifications, conducting drug and cosmetic review-related technical support and services.
Cosmetics Registration Process
Product Classification & Claim Management
Determine product as general cosmetics or special cosmetics (hair dye, perm, whitening, sunscreen, anti-hair loss etc.) per "Cosmetic Supervision Regulations", manage efficacy claims
Domestic Agent Legal Authorization
Appoint qualified Domestic Agent, establish legal compliance framework ensuring compliance with "Cosmetic Supervision Regulations" responsibility requirements
Safety Assessment & Efficacy Evaluation
Complete product safety assessment report, special cosmetics conduct efficacy claim evaluation (human efficacy evaluation trials, consumer usage tests)
Filing Testing & Documentation Preparation
Commission qualified testing institutions for microbiological, physicochemical, toxicological tests, compile complete filing/registration dossier
Registration/Filing Platform Submission
Submit electronic application through NMPA Online Service Hall - Cosmetic Registration and Filing Information Service Platform
Technical Review & Filing Completion
General cosmetics: completed after filing (within 5 working days); Special cosmetics: technical review (within 90 working days)
Post-Market Safety Monitoring
Establish adverse reaction monitoring and reporting system, submit annual reports as required, cooperate with market supervision department inspections
Health Foods (Blue Hat Products) Registration
Regulatory Requirements
- Health Food Registration Certificate (Registration) / Filing Certificate (Filing)
- Product formula, process, quality standard research data
- Safety evaluation data (toxicological tests, hygienic tests)
- Health function evaluation data (functional tests, population consumption evaluation)
- Product quality standards (enterprise standards) and stability study data
- Chinese labeling compliant with "Health Food Labeling Management Regulations"
- Product testing reports (functional ingredients/marker ingredients, contaminants, microbiological tests)
- Authorization letter and qualification documents of Domestic Agent
- Raw material legal source certificates and safety data
- Manufacturing process flow chart and critical control point description
- R&D report and literature references
- Three batches of pilot production records and test reports
Main Process
- Product classification confirmation (Registration/Filing)
- Domestic Agent qualification review and authorization
- Formula research and safety/efficacy evaluation
- Sample trial production and testing
- Registration/Filing dossier compilation
- SAMR administrative acceptance and technical review
- On-site audit and sampling inspection
- Registration approval and filing completion
Registration Timeline
Filing Health Foods: 3-6 months
Registration Health Foods: 18-36 months
New Ingredient Products: 24-48 months
Official Fees
Registration Application Fee: ¥20,000 - ¥50,000
Registration Testing Fee: ¥50,000 - ¥200,000
Filing Fee: ¥0 (Free)
Service Fees
Filing Products: $15,000 - $30,000
Registration Products: $40,000 - $120,000
New Function Products: $80,000 - $200,000
Regulatory System Overview
NMPA
National Medical Products Administration
Under State Administration for Market Regulation, exercising authority under Drug Administration Law, Medical Device Regulations, Cosmetic Supervision Regulations, responsible for nationwide pre-market approval, quality management, post-market surveillance, and market regulation of drugs, medical devices, cosmetics.
SAMR
State Administration for Market Regulation
Directly under State Council, responsible for health food and special food registration/filing management, unified market comprehensive supervision, organizing and guiding market supervision comprehensive law enforcement, maintaining market order.
NIFDC
National Institutes for Food and Drug Control
Directly under NMPA, responsible for national supervision sampling, re-inspection, quality standard development/revision, testing technology research for drugs, medical devices, cosmetics, health foods, providing technical support for supervision.
CMDE
Center for Medical Device Evaluation, NMPA
Responsible for medical device registration technical review, organizing development of medical device technical review specifications, conducting medical device review-related technical support and services.
CDE
Center for Drug Evaluation, NMPA
Responsible for drug and cosmetic registration technical review, developing relevant technical review specifications, conducting drug and cosmetic review-related technical support and services.
Health Foods (Blue Hat Products) Registration Process
Product Pathway Determination
Determine applicable filing management or registration management (new ingredients, new functions require registration) per "Health Food Ingredient Catalog"
Domestic Agent Legal Authorization
Appoint qualified Domestic Agent, establish legal compliance framework ensuring compliance with "Health Food Registration and Filing Management Measures"
Safety & Efficacy Evaluation
Registration products conduct toxicological, functional tests; Filing products provide raw material safety literature references
Sample Trial Production & Testing
Complete three batches of pilot production, commission qualified testing institutions for full item testing (functional ingredients, contaminants, microbiological tests)
Registration/Filing Dossier Compilation
Compile complete application materials per "Health Food Registration Application Material Requirements", including R&D report, quality standards
Technical Review & On-site Audit
State Administration for Market Regulation Food Review Center technical review (Registration: 120-240 working days), conduct on-site audit when necessary
Approval & Post-Market Management
Obtain Health Food Registration Certificate or Filing Certificate, establish adverse reaction monitoring system, cooperate with market supervision sampling