Hong Kong Product Registration & Certification
Important Notes
- Medical Device Voluntary Listing System (MDARS): Medical devices operate under a voluntary administrative control system, though public hospital procurement typically mandates listing. Successful listing relies on technical documentation compliant with international standards (e.g., ISO 13485) and appointment of a local responsible person.
- Cosmetic Safety Responsibility System: Cosmetics require no pre-market approval, but suppliers (importers/manufacturers) bear absolute safety responsibility, must maintain a Product Information File (PIF) with safety assessment, and ensure labeling compliance.
- Dietary Supplements as "General Food": Vitamins, minerals, herbal extracts, etc., without disease claims are imported and sold as general food. No pre-market license from the Department of Health is required, but products must fully comply with food safety and labeling regulations.
- Mandatory Local Responsible Entity: All three product categories require a clear Hong Kong local company (importer, distributor, responsible person) as the legal responsible entity for product compliance, safety, and regulatory communication.
- Strict Legal Boundaries for Labeling & Advertising Claims: Unsubstantiated medical claims on all product labels and advertisements are strictly prohibited. Food (including dietary supplements) claims must be truthful, non-misleading, and must NOT imply therapeutic effects, or face severe enforcement.
- High Recognition of International Standards & Certifications: Hong Kong regulators widely adopt and recognize international standards (ISO, ICH, Codex, etc.) and relevant certifications/safety conclusions from major markets like the US, EU, and UK to streamline assessments.
Hong Kong Specific Requirements
- Efficient & Flexible Self-Regulation & Responsibility Model: While ensuring safety baselines, employs an enterprise-responsibility-led approach for devices (voluntary listing), cosmetics (responsible entity), and food (post-market surveillance), creating efficient processes.
- Mature, Rational & Highly Internationalized Consumer Market: Consumers clearly distinguish between medical devices, cosmetics, and dietary supplements, placing high value on brand reputation, safety credentials, scientific evidence, and international certifications, with zero tolerance for exaggerated claims.
- Distinct Public-Private Channels Drive Different Strategies: High-end private hospitals/clinics are core market for innovative devices; chain drugstores, personal care stores, and premium supermarkets are main retail channels for cosmetics and supplements; public procurement has specific compliance requirements.
- Strategic Regional Hub & Brand Platform: Free port status, mature legal system, and internationally-aligned regulatory environment make Hong Kong the preferred testing ground, logistics center, and brand-building base for health brands entering Mainland China and Asia-Pacific markets.
- "Food vs. Drug" Boundary as Highest Compliance Risk: Regulators enforce strict penalties against food products making illegal drug claims. Core corporate compliance management lies in precise product positioning and impeccable labeling/advertising.
Medical Devices Registration
Regulatory Requirements
- Technical documentation compliant with international standards (ISO 13485, IEC 60601)
- Medical device classification (Class I, II, III, IV) self-determination
- Complete bilingual (Chinese/English) labeling and instructions for use
- Quality Management System Certificate (ISO 13485)
- Clinical evaluation report or equivalence proof (Class IIb, III, IV)
- Appointment of Hong Kong Local Responsible Person
- Declaration of Conformity (DoC)
- Post-market Surveillance (PMS) and vigilance system plan
- UDI coding (where applicable)
Main Process
- Product classification and pathway determination
- Technical documentation and QMS preparation
- Appointment of Hong Kong Local Responsible Person
- MDARS application submission to Department of Health
- Obtain Medical Device Listing Certificate
- Implement post-market surveillance
Registration Timeline
3-9 months
Official Fees
HKD 8,000 - 50,000
Service Fees
HKD 50,000 - 200,000
Regulatory System Overview
Department of Health
Hong Kong Department of Health
Implements the Medical Device Administrative Control System (MDARS), processes medical device listing applications; enforces the Consumer Goods Safety Ordinance for cosmetics regulation; and provides general regulatory guidance for food safety.
Centre for Food Safety
Centre for Food Safety, Food and Environmental Hygiene Department
Responsible for enforcing food safety regulations under the Public Health and Municipal Services Ordinance, including import spot checks, labeling compliance inspections, and handling food safety incidents for dietary supplements and general foods.
Hong Kong Customs
Hong Kong Customs and Excise Department
Handles customs clearance for all imports/exports, inspects goods for regulatory compliance (labeling, permits), and combats counterfeit and unsafe consumer goods (including cosmetics and food products).
Medical Devices Registration Process
Determine Classification & Pathway
Self-determine product risk classification per Medical Device Administrative Control System guidelines, assess need for clinical evaluation.
Prepare Compliance Documentation
Compile technical files, QMS certificates, clinical evaluation reports, and bilingual labeling drafts.
Appoint Local Responsible Person
Designate a Hong Kong-registered company as Local Responsible Person for DoH communication and post-market matters.
Submit MDARS Application
Submit Medical Device Administrative Control System application through DoH electronic portal.
Obtain Listing Certificate
Upon DoH document review approval, receive Medical Device Listing Certificate for legal marketing.
Cosmetics Registration
Regulatory Requirements
- Product Safety Assessment Report (signed by qualified safety assessor)
- Complete Product Information File (PIF)
- Bilingual labeling (Chinese/English) compliant with Consumer Goods Safety Ordinance
- Good Manufacturing Practice (GMP) certification or declaration
- Hong Kong local supplier/importer information
- Complete ingredient list with safety data
- Stability testing report
- Microbiological limit testing report
Main Process
- Ingredient safety assessment and compliance review
- Establish Product Information File (PIF)
- Prepare compliant bilingual labeling
- Designate Hong Kong responsible supplier
- Participate in Voluntary Cosmetic Registration Scheme (optional)
- Launch and fulfill market surveillance responsibilities
Registration Timeline
1-3 months
Official Fees
HKD 0 - 3,000 (voluntary registration fee)
Service Fees
HKD 20,000 - 80,000
Regulatory System Overview
Department of Health
Hong Kong Department of Health
Implements the Medical Device Administrative Control System (MDARS), processes medical device listing applications; enforces the Consumer Goods Safety Ordinance for cosmetics regulation; and provides general regulatory guidance for food safety.
Centre for Food Safety
Centre for Food Safety, Food and Environmental Hygiene Department
Responsible for enforcing food safety regulations under the Public Health and Municipal Services Ordinance, including import spot checks, labeling compliance inspections, and handling food safety incidents for dietary supplements and general foods.
Hong Kong Customs
Hong Kong Customs and Excise Department
Handles customs clearance for all imports/exports, inspects goods for regulatory compliance (labeling, permits), and combats counterfeit and unsafe consumer goods (including cosmetics and food products).
Cosmetics Registration Process
Safety Assessment & Compliance
Ensure all ingredients comply with Hong Kong permitted lists, complete product safety assessment signed by professional.
Compile PIF & Labeling
Establish PIF containing safety assessment, ingredients, manufacturing info, and design compliant bilingual labels.
Designate Local Supplier
Identify Hong Kong importer/distributor as local supplier responsible for product safety.
Voluntary Registration (Optional)
For enhanced credibility, apply to join Department of Health's Voluntary Cosmetic Registration Scheme.
Launch & Market Surveillance
After market launch, local supplier responsible for market surveillance, adverse reaction collection and reporting.
Dietary Supplements (General Food) Registration
Regulatory Requirements
- Food safety proof compliant with Public Health and Municipal Services Ordinance
- Complete ingredient list with specifications
- Chinese/English product labeling (strictly NO medicinal/therapeutic claims)
- Good Manufacturing Practice (GMP) certification (recommended)
- Hong Kong local importer or distributor information
- Stability or shelf-life data (if applicable)
- Safety testing reports (heavy metals, microbiology, etc.)
- Certificate of Origin and Free Sale Certificate (optional, for credibility)
Main Process
- Product positioning and claims compliance review
- Prepare food safety and quality documentation
- Design compliant food labeling
- Designate Hong Kong local importer
- Product import and customs clearance
- Fulfill food safety responsibilities
Registration Timeline
1-2 months (primarily document prep & logistics)
Official Fees
HKD 0 (no registration fee, includes customs charges)
Service Fees
HKD 15,000 - 60,000
Regulatory System Overview
Department of Health
Hong Kong Department of Health
Implements the Medical Device Administrative Control System (MDARS), processes medical device listing applications; enforces the Consumer Goods Safety Ordinance for cosmetics regulation; and provides general regulatory guidance for food safety.
Centre for Food Safety
Centre for Food Safety, Food and Environmental Hygiene Department
Responsible for enforcing food safety regulations under the Public Health and Municipal Services Ordinance, including import spot checks, labeling compliance inspections, and handling food safety incidents for dietary supplements and general foods.
Hong Kong Customs
Hong Kong Customs and Excise Department
Handles customs clearance for all imports/exports, inspects goods for regulatory compliance (labeling, permits), and combats counterfeit and unsafe consumer goods (including cosmetics and food products).
Dietary Supplements (General Food) Registration Process
Claims Compliance Review
Strictly review all labeling and advertising copy to ensure only nutritional claims, NO disease treatment/prevention claims (implied or explicit).
Prepare Quality Documentation
Compile ingredient specifications, safety test reports, GMP certificates, etc., proving product meets general food safety requirements.
Label Design & Review
Design Chinese/English labels compliant with Hong Kong Food and Drugs (Composition and Labeling) Regulations.
Engage Local Importer
Partner with licensed Hong Kong food importer responsible for import, customs clearance, and local distribution legal duties.
Import & Market Surveillance
Product can be sold after customs clearance. Importer must ensure supply chain safety and respond to regulatory spot checks.