Singapore Product Registration & Certification
Important Notes
- HSA Mandatory Product Registration & Licensing: All pharmaceuticals, medical devices, health products, and cosmetics require marketing authorization from the Health Sciences Authority, known for efficiency, rigor, and science-based assessment.
- Granular Classification of Health Products: Chinese Proprietary Medicines, vitamins, herbal products, etc., are finely categorized with distinct pathways, ingredient requirements, and claim restrictions.
- Local Company as Product Registrant: A foreign manufacturer must appoint a locally incorporated Singapore company as the Product Registrant, serving as the legal applicant and responsible party.
- Mandatory English Labeling: All product information, including labels, inserts, and advertisements, must be in English, fully compliant with HSA’s detailed guidelines.
- Free Pricing & High-Value Market Characteristics: There is no government price control. Consumers have high purchasing power and place a premium on quality, brand, and innovation.
- Extensive Adoption & Mutual Recognition of High-Standard Certifications: HSA has MRAs with several SRAs, allowing streamlined or abridged reviews for products approved by agencies like the US FDA and EU EMA.
Singapore Specific Requirements
- Asia-Pacific’s Premier Regulatory & Commercial Hub: Renowned for world-class regulatory efficiency, transparency, and IP protection, serving as a premium gateway and regional HQ location.
- Highly Sophisticated, Rational & Experienced Consumers: Among the world’s most educated consumers, demanding authenticity, scientific backing, and brand reputation, requiring highly professional marketing.
- Integrated Health Management Embracing TCM-WM: Modern medicine and HSA-registered Chinese Proprietary Medicines are widely accepted and integrated into daily wellness and primary care.
- Global Clinical Trial & R&D Center: Advanced infrastructure, strict ethics, and a diverse population make Singapore an ideal base for APAC clinical trials and early-stage R&D.
- Active Advocate & Practitioner of Regional Harmonization: A key member of ASEAN working groups, Singapore actively drives and implements regional mutual recognition schemes, setting regional benchmarks.
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration (MDREG)
- Classification Management by Risk Level (Class A, B, C, D)
- Complete Technical Documentation and Compliance Evidence
- Quality Management System Certificate (ISO 13485)
- English Labeling and Instructions for Use
- Compliance with ASEAN Medical Device Directive (AMDD)
- Product Technical File
- Clinical Evidence (if applicable)
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Conformity Assessment Completion
- Local Agent Appointment
- HSA Registration Application
- Registration Certificate Acquisition
Registration Timeline
4-9 months
Official Fees
SGD 2,500 - 35,000
Service Fees
$10,000 - $32,000
Regulatory System Overview
HSA
Health Sciences Authority Singapore
Responsible for registration approval, quality supervision, and market regulation of medical devices, pharmaceuticals, and cosmetics. Operates as the primary health product regulatory authority under the Singapore Ministry of Health.
SFA
Singapore Food Agency
Responsible for regulatory approval of food and health supplements, ensuring product safety, quality, and labeling compliance
EnterpriseSG
Enterprise Singapore
Responsible for product quality standards certification, enterprise capability development, and international market access support
Medical Devices Registration Process
Product Classification Determination
Determine product risk classification according to Singapore medical device regulations (Class A-D)
Technical Documentation Preparation
Prepare complete English technical documentation including declaration of conformity, test reports, etc.
Local Agent Appointment
Appoint registration agent in Singapore responsible for HSA communications
HSA Registration Application
Submit medical device registration application through MEDICS system
Technical Review
Pass HSA technical documentation review and conformity assessment
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Notification
- Complete Product Information File (PIF)
- Product Safety Assessment Report
- Good Manufacturing Practice Certification
- English Product Labeling
- Ingredient Safety Data
- Product Usage Instructions
Main Process
- Safety Assessment Completion
- Product Information File Preparation
- CPR System Notification
- Local Responsible Person Appointment
- Market Access Completion
Registration Timeline
1-3 months
Official Fees
SGD 400 - 3,000
Service Fees
$4,000 - $10,000
Regulatory System Overview
HSA
Health Sciences Authority Singapore
Responsible for registration approval, quality supervision, and market regulation of medical devices, pharmaceuticals, and cosmetics. Operates as the primary health product regulatory authority under the Singapore Ministry of Health.
SFA
Singapore Food Agency
Responsible for regulatory approval of food and health supplements, ensuring product safety, quality, and labeling compliance
EnterpriseSG
Enterprise Singapore
Responsible for product quality standards certification, enterprise capability development, and international market access support
Cosmetics Registration Process
Safety Assessment
Complete product safety assessment report by qualified safety assessor
Product Information File
Prepare complete product information file including all technical data
CPR Notification Submission
Submit product notification through Cosmetic Product Registration system
Local Responsible Person
Appoint responsible person in Singapore for product compliance
Post-Market Surveillance
Establish serious adverse reaction monitoring and reporting system
Health Supplements Registration
Regulatory Requirements
- Health Supplement Notification (SFA)
- Ingredient Compliance Assessment
- English Product Labeling
- Good Manufacturing Practice Certification
- Health Claims Compliance
- Nutritional Composition Analysis
- Product Specification Documentation
Main Process
- Ingredient Compliance Assessment
- Technical Documentation Preparation
- SFA Notification Submission
- Labeling Review Preparation
- Market Access Completion
Registration Timeline
2-4 months
Official Fees
SGD 800 - 8,000
Service Fees
$5,000 - $14,000
Regulatory System Overview
HSA
Health Sciences Authority Singapore
Responsible for registration approval, quality supervision, and market regulation of medical devices, pharmaceuticals, and cosmetics. Operates as the primary health product regulatory authority under the Singapore Ministry of Health.
SFA
Singapore Food Agency
Responsible for regulatory approval of food and health supplements, ensuring product safety, quality, and labeling compliance
EnterpriseSG
Enterprise Singapore
Responsible for product quality standards certification, enterprise capability development, and international market access support
Health Supplements Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with Singapore health supplement permitted lists
Technical Documentation Preparation
Prepare product formulation, safety evidence, quality specifications documents
SFA Notification Submission
Submit health supplement notification to Singapore Food Agency
Labeling Review
Ensure labeling fully complies with Singapore food labeling requirements
Claims Compliance Review
Review all health claims for compliance with Singapore health claims guidelines