Taiwan Medical Device and Pharmaceutical Regulations

Taiwan’s Ministry of Health and Welfare (MOHW) is the government ministry responsible for the country’s healthcare regulations. The MOHW has a broad mandate to improve the quality of healthcare, prevent and control infectious diseases, ensure food and drug safety, and facilitate technological development. Within the MOHW, the Taiwan Food and Drug Administration (TFDA) is responsible for managing the regulatory system for the safety and quality of food, drugs, medical devices, and cosmetics. The TFDA drafts and implements regulations, grants product registration and clinical trial approvals, monitors manufacturing and importation, and conducts safety surveillance activities on health products.

The Pharmaceutical Affairs Act

Taiwan’s Pharmaceutical Affairs Act regulates the administration of pharmaceutical affairs, which includes drugs and medical devices, pharmaceutical firms, pharmacies, and other relevant matters. Various regulations were established pursuant to the Pharmaceutical Affairs Act to expand on the details not specifically covered in the Act.

Regulations for Medical Devices in Taiwan

According to the Pharmaceutical Affairs Act, the manufacturing or importation of medical devices, including in vitro diagnostics, is only allowed after a medical device permit license that grants registration and market approval is issued by the MOHW.

The Regulations for Governing the Management of Medical Device outlines the three tier risk-based classification system for medical devices. Class I products are considered low risk, Class II products are considered medium risk, and Class III products are considered high risk. The Regulations also state that the manufacturing of medical devices must comply with the guidelines set forth in the Good Manufacturing Practice (GMP) for Medical Device section of Taiwan’s Pharmaceutical Good Manufacturing Practice Regulations.

The Regulation for Registration of Medical Devices provides detailed guidelines on the registration of medical devices, as well as the change, transfer, extension, and reissuance of damaged or lost medical device permit licenses.

Regulations for Pharmaceuticals in Taiwan

The Pharmaceutical Affairs Act stipulates that the manufacturing or importation of drugs in Taiwan is only allowed after a drug permit license is approved and issued by the MOHW. Applicants must submit information about the ingredients, active pharmaceutical ingredients, specifications, functions, manufacturing process, specification and method of testing, and other related information and certificates, as well as the labels, use instructions, samples, and application fee to the MOHW to obtain registration and market approval.

The Regulations for Registration of Medicinal Products establishes the application and approval criteria and the review procedure for drug products, including Western medicine and traditional Chinese medicine. For Western medicine products, the Taiwanese system distinguishes between the following categories of drugs:

• New drugs – drugs that have new compositions, new therapeutic compounds, or a new method of administration
• Generic drugs – drugs that are identical to a drug already approved in Taiwan in the aspects of ingredients, dosage form, contents, and efficacy
• Bio-pharmaceuticals – serums, antitoxins, vaccines, toxic, bacteria sap, and products manufactured based on the theories of microbiology and immunology
• Substances (active pharmaceutical ingredients) – an active substance or ingredient manufactured through physical and chemical processes or bio-tech procedures, and with pharmacological effects that are often used for the manufacturing of drugs, bio-pharmaceuticals or bio-tech products
• Radiopharmaceutical drugs – drugs containing radioactive substances for human uses that can diagnose, monitor, treat, or alleviate disease conditions, or achieve other medical effects

Taiwan’s Good Manufacturing Practice Regulations

Taiwan’s good manufacturing practice (GMP) standards for the design, development, production, installation, and servicing of medical devices follow the medical device quality management system of the International Standard Organization (ISO 13485). GMP approval is required before a manufacturer or importer can received product registration approval from the MOHW.

For pharmaceuticals, the good manufacturing practices for the manufacturing, processing, re-packaging, packaging, storage, and distribution of Western medicinal products will be established with reference to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

For more detailed information about registration requirements and the regulatory pathway for medical devices and pharmaceuticals in Taiwan, please see Medical Device Registration in Taiwan and Pharmaceutical and API Product Registration in Asia.

Taiwan Medical Device and Pharmaceutical Regulatory Resources

For more free information and resources on the Asian medical device and pharmaceutical regulations and healthcare markets, please check out our Resource Center and Blog.