Macau Product Registration & Certification
Important Notes
- Regulated by ISAF: Pharmaceuticals, medical devices, and Chinese herbal medicines are regulated by the Macau Special Administrative Region Government's Pharmaceutical Administration Bureau for registration, approval, and supervision.
- Reference-Based Registration Approval: The registration review for drugs and devices typically references existing marketing approvals from designated regulatory authorities such as China NMPA, Hong Kong Department of Health, EU, or US FDA.
- Local Company as Registration Applicant: Foreign manufacturers must appoint a legally registered local company in Macau (pharmacy, trading company, or manufacturer) as the registration applicant to submit documentation and act as the responsible party.
- Labeling & Language Requirements: Product labels and instructions must be in Chinese (Traditional or Simplified) and Portuguese. Key information must be clearly displayed in both languages, complying with ISAF labeling guidelines.
- Special Management of Chinese Medicines: Chinese medicines (including proprietary Chinese medicines and herbs) have separate registration and management rules, requiring quality standards, safety, and traditional use evidence.
- Import Permit & Distribution License: Besides product registration, importers need to apply for an import permit for each shipment. Separate distribution licenses are required for wholesale or retail of pharmaceuticals.
Macau Requirements
- Micro-Market Driven by Tourism & Healthcare: With a local population of only ~700,000, the market is minuscule. However, its developed tourism industry (including medical tourism) and healthcare services within luxury hotels and casinos create demand for specific high-end drugs and devices.
- High Import Dependency & Reliance on Neighboring Markets: With no large-scale manufacturing, nearly all healthcare products are imported. Regulatory approval heavily relies on existing approvals from Hong Kong, Mainland China, and other major markets, resulting in a relatively streamlined process.
- Bilingual (Chinese-Portuguese) Administrative & Legal System: As a Special Administrative Region of China, both Chinese and Portuguese are official languages, giving legal and administrative procedures a bilingual character that requires document preparation accordingly.
- Coexistence of Public & Private Healthcare Systems: A government-run primary healthcare network serves residents, but high-end and specialist care is mainly provided by private hospitals and clinics, which constitute the main market for innovative products.
- Potential as Part of the Greater Bay Area: With deepening integration of the Guangdong-Hong Kong-Macau Greater Bay Area, Macau's role in Chinese medicine development, specialized healthcare, and as a platform for trade with Portuguese-speaking countries may present new market opportunities.
Medical Devices Registration
Regulatory Requirements
- Medical Device Import License (Licença de Importação de Dispositivos Médicos)
- Classification Management by Risk Level (Class I, IIa, IIb, III)
- Complete Technical Documentation in Chinese/Portuguese
- Quality Management System Certificate (ISO 13485)
- Bilingual Labeling (Chinese and Portuguese)
- Macau Registered Importer Appointment
- Declaration of Conformity to International Standards
- Clinical Evaluation Report (Class IIb, III devices)
- Product Testing Reports from Accredited Laboratories
- Sterilization Validation (if applicable)
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Local Testing Completion
- Macau Importer Appointment
- Import License Application
- Health Bureau Technical Review
Registration Timeline
8-18 months
Official Fees
MOP 8,000 - 150,000
Service Fees
$15,000 - $45,000
Regulatory System Overview
Macau Health Bureau
Macau Health Bureau (Direcção dos Serviços de Saúde)
The primary regulatory authority responsible for import approval, quality supervision, market surveillance, and post-market monitoring of medical devices, cosmetics, and health products in Macau Special Administrative Region.
Pharmaceutical Department
Pharmaceutical Department of Macau Health Bureau
Specifically handles registration and licensing of pharmaceuticals and medical devices, conducts technical evaluations, and oversees compliance with medical product regulations
DSEDT
Economic and Technological Development Bureau (Direcção dos Serviços de Economia e Desenvolvimento Tecnológico)
Manages import/export licensing, business registrations, consumer protection, and oversees product quality and safety in the market
Medical Devices Registration Process
Product Classification Determination
Determine medical device risk classification according to Macau regulations (Class I, IIa, IIb, III) based on intended use and risk factors
Technical Documentation Preparation
Prepare complete bilingual technical documentation including risk management, clinical evaluation, and performance testing
Macau Importer Registration
Appoint licensed importer in Macau registered with Economic and Technological Development Bureau
Import License Application
Submit complete application package to Pharmaceutical Department of Macau Health Bureau
Technical Review and Approval
Undergo technical documentation review, product assessment, and obtain import license approval
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Notification
- Complete Safety Assessment Report
- Bilingual Labeling (Chinese/Portuguese)
- Good Manufacturing Practice Certification
- Product Information File
- Restricted Substance Compliance Proof
- Microbiological Testing Reports
- Stability Study Data
- Macau Distributor Registration
Main Process
- Formula Safety Assessment
- Technical Documentation Preparation
- Product Testing Completion
- Distributor Appointment
- Health Bureau Notification
- Market Launch Preparation
Registration Timeline
4-9 months
Official Fees
MOP 3,000 - 35,000
Service Fees
$8,000 - $20,000
Regulatory System Overview
Macau Health Bureau
Macau Health Bureau (Direcção dos Serviços de Saúde)
The primary regulatory authority responsible for import approval, quality supervision, market surveillance, and post-market monitoring of medical devices, cosmetics, and health products in Macau Special Administrative Region.
Pharmaceutical Department
Pharmaceutical Department of Macau Health Bureau
Specifically handles registration and licensing of pharmaceuticals and medical devices, conducts technical evaluations, and oversees compliance with medical product regulations
DSEDT
Economic and Technological Development Bureau (Direcção dos Serviços de Economia e Desenvolvimento Tecnológico)
Manages import/export licensing, business registrations, consumer protection, and oversees product quality and safety in the market
Cosmetics Registration Process
Formula Compliance Review
Verify all ingredients comply with Macau cosmetic regulations and international safety standards
Safety Documentation Preparation
Prepare comprehensive safety assessment report signed by qualified safety assessor
Macau Distributor Registration
Appoint registered distributor in Macau with valid business registration
Product Notification Submission
Submit cosmetic product notification to Macau Health Bureau with complete technical file
Labeling Compliance Verification
Ensure bilingual labeling meets Macau specific requirements including mandatory information in both languages
Health Products Registration
Regulatory Requirements
- Health Product Import Permit
- Safety and Efficacy Evidence
- Bilingual Labeling (Chinese/Portuguese)
- Good Manufacturing Practice Certification
- Quality Control Specifications
- Stability Testing Data
- Macau Authorized Representative
- Product Classification Evidence
- Manufacturing Site Information
Main Process
- Product Category Determination
- Technical Documentation Preparation
- Quality Evidence Compilation
- Local Representative Appointment
- Import Permit Application
- Regulatory Approval
Registration Timeline
5-12 months
Official Fees
MOP 4,000 - 60,000
Service Fees
$10,000 - $28,000
Regulatory System Overview
Macau Health Bureau
Macau Health Bureau (Direcção dos Serviços de Saúde)
The primary regulatory authority responsible for import approval, quality supervision, market surveillance, and post-market monitoring of medical devices, cosmetics, and health products in Macau Special Administrative Region.
Pharmaceutical Department
Pharmaceutical Department of Macau Health Bureau
Specifically handles registration and licensing of pharmaceuticals and medical devices, conducts technical evaluations, and oversees compliance with medical product regulations
DSEDT
Economic and Technological Development Bureau (Direcção dos Serviços de Economia e Desenvolvimento Tecnológico)
Manages import/export licensing, business registrations, consumer protection, and oversees product quality and safety in the market
Health Products Registration Process
Regulatory Classification
Determine appropriate category: general food, dietary supplement, or Chinese medicine product
Technical Dossier Preparation
Compile complete technical documentation including safety evidence, quality specifications, and manufacturing details
Macau Representative Appointment
Appoint authorized representative in Macau registered with relevant authorities
Import Permit Application
Submit health product import permit application to Macau Health Bureau
Claims Substantiation
Provide scientific evidence for all health claims and ensure compliance with Macau regulations