Philippines Product Registration & Certification
Important Notes
- FDA Mandatory Product Notification & Registration: All pharmaceuticals, medical devices, health supplements, cosmetics, and foods require product notification or registration with the Food and Drug Administration.
- Strict Regulation of Food Supplements as Independent Category: Vitamins, minerals, etc., are clearly classified as Food Supplements requiring product notification. Ingredients, claims, and advertising are strictly monitored by FDA.
- Local Responsible Trader System: A foreign manufacturer must appoint a locally registered Philippine company as the Responsible Trader, who is the applicant and assumes post-market responsibilities.
- English/Filipino Labeling Requirement: Product labels must be in English and Filipino. All documents submitted to FDA must be in English.
- Price Regulation & Influence of National Health Insurance: Prices of some essential drugs are monitored. The reimbursement and procurement policies of PhilHealth significantly impact drug market access.
- Reference to ASEAN Harmonization & US Standards: The Philippines actively participates in ASEAN harmonization for pharmaceuticals and cosmetics, while its medical device regulations are influenced by the US system.
Philippines Specific Requirements
- Large & High-Growth Market with Significant Potential: A young population, economic growth, and rising health awareness drive rapid expansion of the healthcare consumption market.
- Strong Regulatory Enforcement & Highly Institutionalized Processes: The FDA is known for standardized but meticulous processes and strict penalties for non-compliance.
- Highly Developed Private Healthcare & Retail Pharmacy Network: A robust private hospital system and extensive pharmacy chains are the core sales channels, fostering intense competition.
- High Consumer Trust in Brands & Professional Recommendations: Consumers are loyal to international brands and recommendations from healthcare professionals, making professional education and channel relations key to marketing.
- Active ASEAN Member & Representative of US-Influenced Regulatory Culture: The Philippines is active in ASEAN harmonization while its regulatory framework reflects significant US influence, creating a unique regional blend.
Medical Devices Registration
Regulatory Requirements
- Certificate of Product Registration (CPR)
- Classification Management by Risk Level (Class I, II, III, IV)
- Complete Technical Documentation and Test Reports
- Quality Management System Certificate (ISO 13485)
- English Labeling and Instructions for Use
- Free Sale Certificate
- Product Technical File
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- LTO Application Submission
- CPR Registration Application
- Local Representative Appointment
- Registration Certificate Acquisition
Registration Timeline
6-12 months
Official Fees
PHP 50,000 - 1,500,000
Service Fees
$12,000 - $35,000
Regulatory System Overview
FDA Philippines
Food and Drug Administration Philippines
Responsible for registration approval, quality supervision, and market regulation of health products including medical devices, cosmetics, food supplements, pharmaceuticals, and food. Operates as the primary regulatory authority under the Philippine Department of Health.
DOH
Department of Health Philippines
Responsible for developing national health policies, regulatory frameworks, and public health standards, overseeing FDA operations and enforcement
Bureau of Customs
Bureau of Customs Philippines
Responsible for customs clearance, tax collection, and trade compliance regulation of imported products
Medical Devices Registration Process
Product Classification Determination
Determine product risk classification according to ASEAN Medical Device Directive (Class I-IV)
Technical Documentation Preparation
Prepare English technical documentation, test reports, quality management system certificates, etc.
Local Representative Appointment
Appoint authorized representative in Philippines and apply for License to Operate (LTO)
CPR Application Submission
Submit medical device Certificate of Product Registration application to FDA Philippines
Technical Review
Pass FDA technical documentation review and quality management system assessment
Cosmetics Registration
Regulatory Requirements
- Certificate of Product Notification (CPN)
- Ingredient Safety Assessment Report
- English Product Labeling
- Good Manufacturing Practice Certification
- Product Information File
- Ingredient Restrictions Compliance Proof
Main Process
- Ingredient Compliance Assessment
- Safety Assessment Completion
- CPN Notification Submission
- Labeling Review Preparation
- Market Access Completion
Registration Timeline
2-4 months
Official Fees
PHP 25,000 - 200,000
Service Fees
$5,000 - $15,000
Regulatory System Overview
FDA Philippines
Food and Drug Administration Philippines
Responsible for registration approval, quality supervision, and market regulation of health products including medical devices, cosmetics, food supplements, pharmaceuticals, and food. Operates as the primary regulatory authority under the Philippine Department of Health.
DOH
Department of Health Philippines
Responsible for developing national health policies, regulatory frameworks, and public health standards, overseeing FDA operations and enforcement
Bureau of Customs
Bureau of Customs Philippines
Responsible for customs clearance, tax collection, and trade compliance regulation of imported products
Cosmetics Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with ASEAN Cosmetic Directive approved lists
Safety Assessment Report
Prepare product safety assessment report by qualified safety assessor
CPN Notification Submission
Submit cosmetic product notification application to FDA Philippines
Labeling Compliance Review
Ensure labeling fully complies with ASEAN cosmetic labeling requirements
Local Representative Registration
Complete product notification registration through authorized representative
Food Supplements Registration
Regulatory Requirements
- Certificate of Food Supplement Notification (CFSN)
- Ingredient Safety and Quality Standards Proof
- English Product Labeling
- Good Manufacturing Practice Certification
- Scientific Basis for Health Claims
- Nutritional Composition Analysis
Main Process
- Product Classification Confirmation
- Technical Documentation Preparation
- CFSN Notification Submission
- Labeling Review Preparation
- Notification Certificate Acquisition
Registration Timeline
3-6 months
Official Fees
PHP 30,000 - 300,000
Service Fees
$7,000 - $18,000
Regulatory System Overview
FDA Philippines
Food and Drug Administration Philippines
Responsible for registration approval, quality supervision, and market regulation of health products including medical devices, cosmetics, food supplements, pharmaceuticals, and food. Operates as the primary regulatory authority under the Philippine Department of Health.
DOH
Department of Health Philippines
Responsible for developing national health policies, regulatory frameworks, and public health standards, overseeing FDA operations and enforcement
Bureau of Customs
Bureau of Customs Philippines
Responsible for customs clearance, tax collection, and trade compliance regulation of imported products
Food Supplements Registration Process
Product Classification Confirmation
Confirm product meets food supplement definition and does not fall under drug category
Technical Documentation Preparation
Prepare ingredient analysis, safety evidence, nutritional composition documents
CFSN Notification Submission
Submit food supplement notification application to FDA Philippines
Labeling Review
Ensure labeling complies with Philippine food labeling requirements
Claims Compliance Review
Review all health claims for compliance with Philippine food claims regulations