With the global trend of aging populations and the increase of all kinds of cancer and chronic disease patients, the demands for medical devices in human societies will definitely continue to grow. On top of distance medical care systems extensively discussed or adopted in various countries in recent years, the development of high-end medical devices such as automated equipment and test systems, cloud medical treatment, monitoring and testing products or innovative medical devices that incorporate 3D printing technologies will certainly attract the attention of relevant industries and individuals. To allow domestic and overseas enterprises aspiring to invest and participate in the medical device industry to understand the regulatory framework for the industry at issue, this article hereby summarizes the classified administration of medical devices in Taiwan, including but not limited to relevant registration requirements and practical measures.
The primary legal basis for regulating medical devices in Taiwan is the Pharmaceutical Affairs Act and the relevant administrative rules prescribed by the Ministry of Health and Welfare (hereinafter, the “Ministry”). Under the Pharmaceutical Affairs Act, “medical devices” refer to apparatuses, instruments, implements, substances, software, in vitro agents and relevant articles which are used for diagnosis, treatment, alleviation or direct prevention of human diseases, birth control or which are sufficient to affect the body structure and functions of people instead of acting on human bodies through pharmacology, immunity or metabolism in order to achieve their major functions. Any operator planning to manufacture or sell medical devices in Taiwan is required to apply to health authorities in municipalities under the direct jurisdiction of the central government or counties (cities) for registration pursuant to the Pharmaceutical Affairs Act and obtain a license for pharmaceutical business in order to commence operation In addition, before any specific medical device is manufactured or imported, application shall be filed with the Ministry for registration first, along with the payment of a fee. Such manufacture or importation shall not commence without a license for medical devices issued upon approval of the application. The license for the manufacture or import of medical devices has a term of five years. If manufacture and import are still sought after the license expires, application to the Ministry for extension shall be filed in advance. However, each extension shall not exceed five years. In addition, even if the term of a manufacturing or import license has not expired, when the Ministry determines that certain medical devices do raise safety or medical efficacy concerns as a result of its re-evaluation, the Ministry may order the pharmaceutical operator to rectify within a specified period. If the operator fails to rectify within such period, its license may be revoked. However, in the event of material safety concerns, the license may be revoked directly.
According to the Regulations for Governing the Medical Devices and the Examination Regulation for the Registration of Medical Devices prescribed by the Ministry, medical devices in Taiwan are categorized under Class 1 (low risk), Class 2 (medium risk) and Class 3 (high risk) based on their risk level. The differentiation information in the Categorization and Classification Table for Medical Devices promulgated by the Ministry may be referenced to determine the classes. However, since medical device categorization and classification are highly professional, no mechanical determination can be made based on the definitions or product names in the above categorization and classification table. Therefore, both food and drug administrators in the Ministry and relevant court opinions practically hold that if an operator cannot ascertain the class of the medical devices to be manufactured or imported, it may inquire with the Ministry about the category or class of the medical devices (hereinafter, the “Classification Inquiry Procedure”) in accordance with the Regulations for Governing the Medical Devices by submitting documents such as product manuals (catalogues) from the original manufacturers and their detailed Chinese translations (including the usage methods, functions and theories of operation) and reference categorization and classification materials about the products in the US or the European Union to serve as the basis for classification application. In addition, in the event of any contradiction or conflict between the Ministry’s classification determination of specific medical devices and the results of a previous classification inquiry with the Ministry, the pharmaceutical operator may also use the resulted documentation from the previous classification inquiry as evidence for its defense.
Take the application for the importation of medical devices for example. If a medical device is rated as a Class 1 medical device, the following documents should be attached in the registration application of the medical device to be imported: (1) original of the registration application and the affidavit issued by the pharmaceutical operator which indicates that all information provided in the application is accurate and the pharmaceutical operator is willing to accept sanctions such as revocation of its license, cancellation announcement and prohibition against sales and to assume all legal liabilities if the information provided is untrue, fake or in violation of the relevant pharmaceutical laws; (2) copy of the pharmaceutical operator’s license for the business of selling medical devices; and (3) supporting documents evidencing that the manufacturer meets the good manufacturing practices for medical devices. In addition to the above-mentioned documents, if a medical device is rated as a Class 2 or Class 3 medical device, its Chinese language package insert and catalogue, user manual, package, label, color picture of the actual product appearance; the inspection specification and methodology, the original inspection records and inspection performance document for preclinical tests and for the quality control by the original manufacturer; relevant information about the product such as the structure, materials, specification, performance, applications, and drawings; academic and theoretical bases and relevant research reports and materials; and clinical trial reports shall also be provided to the Ministry for substantive review. Since detailed materials such as product manuals and clinical trials are not required in the application for a Class 1 medical device license, unlike Class 2 or Class 3 applications, if application is submitted in person and processed over the counter, if the formal examination is passed, a license may be issued on site on that day at the earliest.
However, since the Ministry’s registration procedure for Class 1 medical devices involves formal review only, if a medical device is regarded as a Class 2 or Class 3 medical device as a result of subsequent review of relevant product documentation, the Ministry’s opinions and relevant court findings show that unless a pharmaceutical operator can prove that the above Classified Inquiry Procedure has been followed and the results of the inquiry show the device is “Class 1,” most practical opinions hold that since the pharmaceutical operator intentionally submits a medical device under Class 1 which should be classified under Class 2 or Class 3 for examination in order to illegally obtain a license through a false affidavit, the previously issued license should be revoked pursuant to law, the pharmaceutical operator should be requested to recall products in stock and sold in the market.
Based on the foregoing reasons, it can be concluded that relevant pharmaceutical laws and regulations in Taiwan adopt classified registration administration over medical devices and require pharmaceutical operators to provide detailed product information to facilitate the review of registration applications for more risky medical devices. However, with respect to the appropriate classification of specific medical devices, they are not indiscriminately tested and determined one by one at the time of review. But rather, the classification responsibilities and risk attribution are assigned to the applicants, followed by administration through post-market surveillance of medical devices. Therefore, if a classification error is suspected, the pharmaceutical operator will be requested to provide relevant product information coupled with explanation. If a classification error is ultimately confirmed, penalties of different degrees of severity such as fines, imprisonment, recall of goods in stock or sold in the market, announcement of violators and details of violation, revocation or cancellation of licenses will be imposed in accordance with the Pharmaceutical Affairs Act.
The manufacture and importation of medical devices not only involve manufacturing process arrangements at factories and the deployment of distribution channels in various places but also affect the performance of supply and demand contracts between upstream and downstream operators. If a specific medical device is found to be erroneously classified, resulting in the above administrative and criminal penalties upon the pharmaceutical operator, not only will the operator sustain immediate economic losses but its reputation in the medical device industry will be greatly impaired. To avoid inadvertent violation of relevant laws as a result of an operator’s erroneous judgment, if the operator believes different categorization and classification opinions concerning the medical device to be manufactured in Taiwan or to be imported may take place based on existing information, such pharmaceutical operator is advised to follow the above Classification Inquiry Procedure before applying for registration to obtain more favorable basis for its defense.