1. Certification Overview
The agency regulating the registration and sale of medical devices in Taiwan is the Food and Drug Administration (TFDA), an agency under the Ministry of Health and Welfare. You must obtain approval from the TFDA before importing medical devices into Taiwan.
In the case of foreign manufacturers, the application must be submitted by a sales agent holding a pharmacist license in Taiwan.
They are divided into in vitro diagnostic reagents and non-in vitro diagnostic reagents and are classified as grades 1 to 3 and newly developed medical devices.
In Vitro Diagnostic Reagents: Medical devices intended for the analysis of specimens outside the body (urine blood glucose reagents, pregnancy test kits, COVID-19 test kits, blood analysis reagents, etc.)
Non-In Vitro Diagnostic Reagents: Refers to devices and equipment that are used directly within the body or come into contact with patients to support diagnosis, treatment, and monitoring.
2. Regulatory Bodies & Basic Information
| Regulatory Agencies | FDA(Food and Drug Administration) |
| Testing Agency | 1. Biosafety Testing Laboratory, Agricultural Technology Research Institute 2. Level Biotechnology Inc. CRO-Preclinical Testing Center 3. Contract Research Organization (CRO), Super Laboratory Co., Ltd |
| Lead time / Price | Varies by product |
| Language | Chinese |
| Agent | Local agent with pharmacist qualifications in Taiwan |
3. Medical Device Classification
| Class | Risk | Example | |
|---|---|---|---|
| Class 1 | Low risk | • Manual Surgical & Clinical Instruments: Surgical forceps, Mechanical stethoscopes • Basic Patient Support & Mobility Aids: Elastic bandages, Manual hospital beds • Non-invasive Examination Tools: Clinical glass thermometers, Surgical eye pads |  Surgical forceps |
| Class 2 | Moderate risk | • Active Diagnostic & Monitoring Systems: Electrocardiograph/ECG machines, Electronic blood glucose monitors • Endoscopic & Dental Instruments: Rigid/Flexible endoscopes, Dental handpieces • Energy-based Aesthetic & Injectable Devices: High-frequency/RF skin care devices, Hyaluronic acid dermal fillers, Contact lenses |  High-frequency/RF skin care devices |
| Class 3 | High risk | • Implantable Cardiac & Circulatory Support Systems: Implantable pacemakers, Coronary/Vascular stents • Life-Sustaining & Anaesthesia Equipment: Mechanical ventilators, Continuous anesthesia machines • Permanent Surgical Implants: Artificial heart valves, Breast implants, Bone screws & plates |  Continuous anesthesia machine |
4. Certification Process
- Determine Taiwan medical device classification based on the TFDA device database
- Designation of a Taiwanese agent capable of registering and managing Taiwanese medical devices and communicating with the TFDA
- Prepare to apply for Quality System Document (QSD) if the device is not exempt
- Submit application, pay related fees
- QSD certificate issued after TFDA document review and approval
- Submit application/required documents to TFDA
- Payment of application fee
- Issuance of Taiwan medical device license after TFDA approval
5. Required Documents
1. Import Item Declaration (Grade 1)
| Essential | 1) Application for Inspection Registration of Class 1 Medical Devices 2) Copy of Medical Device Business License |
| If necessary | 1) Documents proving that the medical device manufacturer complies with the Medical Device Quality Management System (QMS) regulations 2) Product guidelines from the original manufacturer 3) Test specifications and methods, and test reports for preclinical studies 4) Other documents and information designated by the central competent authority |
2. Import Item Permit (Class 2)
| Essential | 1) Application for Medical Device Inspection Registration 2) Two copies of draft label, manual, or packaging 3) Copy of Medical Device Business License 4) Original Foreign Manufacturing Facility Approval Certificate 5) Documents proving that the medical device manufacturer complies with medical device quality management system regulations 6) Documents related to product structure, materials, specifications, functions, uses, and drawings |
| If necessary | 1) Original certificates of manufacture and sale from the country of origin 2) Test specifications and methods, original test records, and test reports for preclinical testing and quality control performed by the original manufacturer 3) Clinical evidence information 4) Radiation safety information regarding equipment generating ionizing radiation 5) Essential Principles (EP) and Summary Technical Documentation (STED) regarding the safety and performance of the medical device 6) Other documents and information designated by the central competent authority 7) Test samples |
3. Import Item Permit (Class 3)
| Essential | 1) Application for Medical Device Inspection Registration 2) Two copies of draft label, instruction manual, or packaging 3) Copy of Medical Device Business License 4) Original Foreign Manufacturing Facility Approval 5) Documents proving that the medical device manufacturer complies with medical device quality management system regulations 6) Test specifications and methods, original test records, and test reports for preclinical trials and quality control performed by the original manufacturer 7) Documents related to product structure, materials, specifications, functions, uses, and drawings 8) Essential Principles (EP) and Summary Technical Documentation (STED) regarding the safety and performance of the medical device |
| If necessary | 1) Original certificate of manufacture and free sale from the country of origin 2) Clinical evidence information 3) Radiation safety information for equipment that generates ionizing radiation 4) Essential Principles (EP) and Summary Technical Document (STED) for Safety and Performance of Medical Devices 5) Other documents and information designated by the central competent authority |
6. Validity Period and Maintenance
- Medical device registration certificate: 5 years
- Renewal Period: Renewal applications must be submitted 6 to 10 months prior to expiration.
- QSD (Quality System Documentation) Certificate: 3 years
- GDP(Good Distribution Practice): 3 years
Source
Regulations governing the approval, registration, and annual notification issuance of medical devices
TFDA Homepage