Taiwan (R.O.C.) Product Registration & Certification
Important Notes
- Regulated by TFDA (MOHW): All pharmaceuticals, medical devices, and cosmetics (including health foods) are centrally regulated by the Taiwan Food and Drug Administration under the Ministry of Health and Welfare, requiring respective licenses or registration.
- Product Classification & License Application: Medical devices are classified by risk (I, II, III) requiring a "Medical Device License." Drugs require a "Drug License." Cosmetics need "Cosmetic Product Notification."
- Technical Documentation & Local Testing: Chinese technical documentation meeting TFDA requirements is needed. Class II/III devices and new drugs often require performance or biocompatibility testing in accredited local labs.
- Local Company as Applicant: Foreign manufacturers must appoint a legally registered local company (e.g., branch, subsidiary, or agent) in Taiwan as the license applicant, bearing legal responsibility for the product.
- Labeling & Instructions Requirements: All labels, instructions, and advertising must be in Traditional Chinese, complying with specific TFDA regulations like the "Labeling Management Measures."
- Health Food "Green Mark" Certification: To make specific health function claims (e.g., blood lipid regulation), products must apply for "Health Food" registration with TFDA to use the "Green Mark" seal; otherwise, they are regulated as general food.
Taiwan Specific Requirements
- Highly Mature & Regulated Independent System: TFDA has established a strict regulatory framework aligned with international (especially US, JP, EU) standards but with local characteristics, known for detailed review and high process transparency.
- Critical Influence of National Health Insurance (NHI): Over 99% population coverage makes inclusion in the NHI reimbursement list paramount for success, but subject to strict price reviews and global budget constraints.
- Demand for Clinical & Local Data: Approval of new drugs and Class III devices places high importance on clinical trial data from Asian regions (including Taiwanese/Chinese populations) or local Taiwan studies.
- Professional Channels & High Consumer Awareness: Hospital market led by large medical centers; pharmacy channel is mature; consumers are health-information-sensitive, valuing brand, certification, and scientific backing.
- Active Push for Digital Health & Smart Medicine: The government is supportive of innovations like digital health, telemedicine, and AI-assisted diagnostics, actively developing corresponding regulations and payment mechanisms.
Medical Devices Registration
Regulatory Requirements
- Medical Device License (Manufacturing/Importing License)
- Risk-based classification: Class I (Registration), Class II/III (Approval)
- Complete technical documentation in Traditional Chinese
- Quality Management System Certificate (ISO 13485 or Taiwan GMP/QMS)
- Clinical evaluation report (Class II/III may require clinical trial data)
- Product testing reports from TFDA-recognized laboratories
- Traditional Chinese labeling meeting TFDA requirements
- Taiwan Drug Distributor License or Authorized Representative agreement
- Factory registration and inspection documents (if applicable)
Main Process
- Determine medical device classification (Class I, II, III)
- Prepare complete technical documentation in Traditional Chinese
- Appoint Taiwan-licensed Drug Distributor or Authorized Representative
- Submit application to TFDA through local representative
- Undergo TFDA technical review and assessment
- Address any additional information requests
- Obtain Medical Device License (valid 5 years)
Registration Timeline
Class I: 3-6 months
Class II: 6-12 months
Class III: 12-18 months
Official Fees
Class I: NT$ 15,000 - 50,000
Class II: NT$ 50,000 - 150,000
Class III: NT$ 100,000 - 300,000
Service Fees
Class I: $8,000 - $15,000
Class II: $12,000 - $25,000
Class III: $20,000 - $40,000
Regulatory System Overview
TFDA
Taiwan Food and Drug Administration, Ministry of Health and Welfare
Primary regulatory authority responsible for medical devices, pharmaceuticals, cosmetics, and health foods. Manages product registration, market surveillance, quality inspections, and enforces the Pharmaceutical Affairs Act and Cosmetic Hygiene Regulations.
MOHW
Ministry of Health and Welfare
Government ministry overseeing healthcare policies, public health, and welfare services. Supervises TFDA operations and establishes regulatory frameworks for healthcare products and food safety.
BSMI
Bureau of Standards, Metrology and Inspection
Responsible for product standards, metrology, and inspection. Certain medical devices may require BSMI certification in addition to TFDA registration for electromagnetic compatibility and safety standards.
Medical Devices Registration Process
Classification Determination
Determine medical device classification (Class I, II, III) according to Taiwan regulations and TFDA classification database.
Technical File Preparation
Compile complete technical documentation including design verification, risk analysis, clinical evaluation, translated to Traditional Chinese.
Appoint Local Representative
Engage a Taiwan-licensed Drug Distributor or Authorized Representative to submit application and assume legal responsibility.
Application Submission
Submit Medical Device License application to TFDA through local representative, including all required documents and fees.
TFDA Review & Assessment
TFDA conducts technical review (Class II/III: 90-180 days; Class I: 30-60 days). May request additional information or testing.
License Issuance
Upon approval, receive Medical Device License valid for 5 years. License holder responsible for post-market surveillance.
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Notification (general cosmetics) or Approval (specific-purpose)
- Product Information File (PIF) in Traditional Chinese
- Safety assessment report by qualified assessor
- Ingredient compliance with Taiwan Cosmetic Hygiene Regulations
- Stability testing data (minimum 3 years shelf life)
- Microbiological testing reports
- Traditional Chinese labeling meeting TFDA requirements
- Good Manufacturing Practice (GMP) compliance evidence
- For specific-purpose cosmetics: additional efficacy data and pre-market approval
Main Process
- Determine product category (general or specific-purpose cosmetic)
- Complete ingredient compliance check and safety assessment
- Prepare Product Information File and technical documentation
- Design Traditional Chinese compliant labeling
- Submit notification (general) or approval application (specific-purpose)
- Obtain notification confirmation or approval certificate
- Maintain PIF for TFDA inspection
Registration Timeline
General cosmetics: 1-3 months
Specific-purpose: 3-6 months
Official Fees
General cosmetics: NT$ 3,000 - 10,000
Specific-purpose: NT$ 20,000 - 100,000
Service Fees
General cosmetics: $4,000 - $8,000
Specific-purpose: $8,000 - $15,000
Regulatory System Overview
TFDA
Taiwan Food and Drug Administration, Ministry of Health and Welfare
Primary regulatory authority responsible for medical devices, pharmaceuticals, cosmetics, and health foods. Manages product registration, market surveillance, quality inspections, and enforces the Pharmaceutical Affairs Act and Cosmetic Hygiene Regulations.
MOHW
Ministry of Health and Welfare
Government ministry overseeing healthcare policies, public health, and welfare services. Supervises TFDA operations and establishes regulatory frameworks for healthcare products and food safety.
BSMI
Bureau of Standards, Metrology and Inspection
Responsible for product standards, metrology, and inspection. Certain medical devices may require BSMI certification in addition to TFDA registration for electromagnetic compatibility and safety standards.
Cosmetics Registration Process
Category Determination
Determine if product is general cosmetic or specific-purpose cosmetic (sunscreen, whitening, anti-aging, acne treatment, etc.).
Ingredient & Safety Review
Verify all ingredients comply with Taiwan Cosmetic Hygiene Regulations. Complete safety assessment by qualified professional.
Technical Documentation
Prepare Product Information File including formulation, manufacturing method, safety data, stability studies (minimum 3 years).
Label Compliance
Design labels in Traditional Chinese meeting all mandatory requirements: ingredient list (INCI), usage instructions, precautions, manufacturer information.
TFDA Notification/Approval
General cosmetics: submit notification through TFDA Cosmetics Product Notification System. Specific-purpose: submit pre-market approval application with efficacy evidence.
Market Launch & Surveillance
After notification/approval, product can be marketed. Maintain PIF for 3 years for TFDA inspection and establish adverse event reporting system.
Health Foods Registration
Regulatory Requirements
- Health Food Permit (Track 1 or Track 2 approval)
- Safety assessment report (acute/sub-chronic toxicity studies)
- Health efficacy evaluation (scientific evidence)
- Product specifications and analytical methods
- Stability study data (minimum shelf life)
- Traditional Chinese labeling requirements
- Good Manufacturing Practice (GMP) certification
- Health Food Permit Mark (Green Person Mark) application
- Manufacturing factory information and quality control
Main Process
- Determine health food track (Track 1: individual review; Track 2: standardized ingredients)
- Conduct safety studies and collect efficacy evidence
- Prepare complete technical documentation
- Submit Health Food Permit application to TFDA
- Undergo expert committee review
- Address review comments and provide additional information
- Obtain Health Food Permit and Green Person Mark authorization
Registration Timeline
Track 1 (Individual Review): 12-24 months
Track 2 (Standardized Ingredients): 8-16 months
Official Fees
Track 1: NT$ 150,000 - 500,000
Track 2: NT$ 100,000 - 300,000
Service Fees
Track 1: $25,000 - $60,000
Track 2: $20,000 - $50,000
Regulatory System Overview
TFDA
Taiwan Food and Drug Administration, Ministry of Health and Welfare
Primary regulatory authority responsible for medical devices, pharmaceuticals, cosmetics, and health foods. Manages product registration, market surveillance, quality inspections, and enforces the Pharmaceutical Affairs Act and Cosmetic Hygiene Regulations.
MOHW
Ministry of Health and Welfare
Government ministry overseeing healthcare policies, public health, and welfare services. Supervises TFDA operations and establishes regulatory frameworks for healthcare products and food safety.
BSMI
Bureau of Standards, Metrology and Inspection
Responsible for product standards, metrology, and inspection. Certain medical devices may require BSMI certification in addition to TFDA registration for electromagnetic compatibility and safety standards.
Health Foods Registration Process
Product Categorization
Determine if product qualifies as health food (with health claims) or general food. Select approval track: Track 1 (individual review) or Track 2 (standardized ingredients).
Safety & Efficacy Evidence
Conduct required safety studies (acute/sub-chronic toxicity) and collect scientific evidence supporting health claims. Track 1 requires more extensive evidence.
Technical Documentation
Compile complete application dossier: safety data, efficacy evidence, manufacturing details, quality control methods, stability data.
TFDA Application Submission
Submit Health Food Permit application to TFDA through authorized representative. Include all required documents and application fees.
Expert Committee Review
TFDA expert committee reviews application (Track 1: 180+ days; Track 2: 120+ days). Committee may request additional information or clarifications.
Permit Issuance
Upon approval, receive Health Food Permit valid for 5 years and authorization to use Health Food Permit Mark (Green Person Mark). Must renew 3 months before expiry.