In 1993, Pharmaceutical Affairs Act was enacted to facilitate the creation of a congenial environment for the development of both the drug and medical device industry in Taiwan. However, as time goes by, drugs and medical devices are too profound, and laws and regulations specifically for medical devices have collaborated globally. To keep in line with international norms, and further ensure the safety, effectiveness, and quality of medical devices, Medical Device Act was released on Jan 15th, 2020, and have come into force on May 1st, 2021.
Unlike Pharmaceutical Affairs Act, Medical Device Act focuses only on medical devices and their related matters. In addition, to fully manage the product life cycle, Medical Device Act not only strengthens the governance of manufacturers and distributors but also considers designers and maintainers part of the industry.
Below lists out the supporting measures and announcements that were launched following Medical Device Act:
1. Overview of the Act
2. Charging of Regulatory Fees
There is an increase in most regulatory fees. For instance, QSD application fees have raised from NTD38,000 to NTD60,000, and Class III Product Registration fees have raised from NTD38,000 to NTD100,000.
3. Regulations Related to Manufacturers
As designing is regarded as part of the manufacturing phase, the establishment of manufacturers is modified. Moreover, to encourage innovative products, a special regulation was launched.
- 3.1 Standards for the Establishment of Medical Device Manufacturers (CH)
- 3.2 Regulations for Contract Manufacturing of Medical Devices (EN)
- 3.3 Regulations Governing Incentive Rewards for Research and Development of Innovative Medical Devices Technology (EN)
4. Regulations Related to Distributors
For distributors in Taiwan, the implementation of Good Distribution Practice (GDP) is a major difference from the past. TFDA has additionally requested medical device dealers of specific product categories to obtain both the Distribution License and the Medical Device License before selling, wholesaling, importing, or exporting medical devices.
- 4.1 Regulations of Medical Device Good Distribution Practice (EN)
- 4.2 Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License (EN)
- 4.3 Medical Device Categories and Related Dealers That Shall Establish a Medical Device Good Distribution System Specified in Article 24 of Regulations for Governing the Management of Medical Device (CH)
- 4.4 Regulations Governing the Sale Items and Compliance Matters of Medical Devices for Distance Sales (CH)
- 4.5 Regulations Governing Border Inspection and Examination of Imported Medical Devices (EN)
- 4.6 Scope and Classification of the Medical Devices Which Pharmacies May Engage in Retail (CH)
- 4.7 Medical Device Vending Machines that are Set-Up by Medical Device Firms (Pharmacies) Are Not Required to Apply Medical Device Dealer Permit at the Business Establishment (CH)
- 4.8 (Draft) Medical Device Product Items That May Be Sold by Vending Machines and the Matters That Shall Be Complied with (CH)
5. Management of Testing Institutions
In order to carry out the certification or entrusted certification of medical device testing institutions, and to improve the management of these institutions, several regulations were established based on ISO/IEC 17025.
- 5.1 Regulations Governing Designation or Commission of Medical Devices Test (EN)
- 5.2 Regulations Governing Accreditation and Outsourced Accreditation Management of Medical Devices Institutions (EN)
6. Product Registration
For low-risk class I medical devices, there is a new registration approach- Medical Device Listing. Those medical devices shall be registered online and renew their listing annually.
For medical devices that required QSD (Quality System Documentation), not only brand owners (legal manufacturers) need to apply for QSD, contract manufacturers (OEM, ODM sites) are also required. In addition, TFDA has canceled the abbreviated approach for medical devices that had obtained both US and EC certificates. Instead, alternative approaches are released for products that are well known on the market.
- 6.1 Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration (EN)
- 6.2 Medical Device Product Items That Shall Obtain Marketing Authorization by Means of Listing (CH)
- 6.3 8 Items That Shall Obtain Marketing Authorization by Means of Listing and Annual Declaration (CH)
- 6.4 Regulations Governing Medical Device Quality Management System (EN)
- 6.5 Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing license (EN)
- 6.6 QMS Application for Manufacturers in the US, Puerto Rico, Guam (CH)
- 6.7 QMS Application for Manufacturers from European Union, Switzerland, and Liechtenstein (CH)
- 6.8 QMS Application for Manufacturers from Japan (CH)
- 6.9 Regulations Governing the Classification of Medical Devices (EN)
7. Requirements of Product Label, IFU, and Package
- 7.1 Requirements Related to the Exemption from Labeling Date of Manufacture and the Period of Validity or Shelf-life on the Labels, Instructions or Packaging of Medical Devices (CN)
- 7.2 Guidance of Composing Chinese IFU (CN)
- 7.3 (Draft) Regulations on the Labels, Instructions or Packaging of Medical Devices which were Directly Listed or Whose Original Licenses were Cancelled by the Central Competent Authority in Accordance with Paragraph 4 of Article 25 of Medical Devices Act (CN)
- 7.4 Labels, Instructions or Packaging of Specific Medical Devices Shall Additionally State the Warnings and Cautions (CN)
8. Regulations Related to Clinical Trials
To protect the rights, safety, and well-being of subjects and to ensure all clinical trials are ethical and scientific-based, Good Clinical Practice (GCP) is adapted and should be carried throughout all clinical trials.
- 8.1 Regulations on Good Clinical Practice for Medical Devices (EN)
- 8.2 Notice of Clinical Trial Documents Technical Evaluation Application and Notice of Clinical Trials Application (CN)
- 8.3 Clinical Trials for Non-significant Risk Medical Devices (CN)
- 8.3 Regulations Governing the Alternative Way of Written Form to Get Agreement of Using, Collecting or Processing Personal Information for Using Medical Devices (CN)
9. Tracking and Tracing of Medical Devices
Unique Device Identifier (UDI) system is implemented to keep track of each medical device from manufacturing process to patient use. Through establishing UDI, both TFDA and manufacturers could better identify potential problems or device defects, leading to the improvement of patient welfare.
- 9.1 Requirements for Indicating the Unique Device Identifier on Medical Device Labels (CN)
- 9.2 Regulations of Medical Device Tracking Management (EN)
- 9.3 Medical Devices That Shall Establish and Maintain Sources and Flow Data and Product Items That Shall Report Sources and Flow Data (CN)
10. Safety Surveillance of Medical Devices
To further develop a more practical and useful safety surveillance system, TFDA has released new regulations related to adverse events reporting and product recall.
- 10.1 Regulations for Management of Medical Device Safety Surveillance (EN)
- 10.2 Designated Product Items for Medical Device Safety Surveillance (EN)
- 10.3 Regulations for Medical Device Recalls (EN)
- 10.4 Regulations for Reporting Serious Adverse Events of Medical Devices (EN)
- 11.1 Regulations for Approval of Specific Medical Devices' Manufacturing or Importing as a Special Case (CN)
- 11.2 Regulations for Management of Medical Devices Technicians (EN)
Medical Device Act