Medical devices were previously governed by the Pharmaceutical Affairs Act. On December 13, 2019, the Legislative Yuan passed the “Medical Device Law” (the “Law”) through the third reading process, separating the governance of these medical devices from the “Pharmaceutical Affairs Law” . This distinction highlights an independent resolution for a more complete regulation system that meets the practical needs of medical device management in order to accelerate their introduction to the market and promote its industrial development. The law entered into force on May 1, 2021 and its relevant rules and standards have been made public. (See appendix for more details)
The law consists of 9 chapters and 85 articles. Its key points are:
I. Regulation of medical device companies
As stipulated in the Pharmaceutical Affairs Act, medical device companies consist of two categories: manufacturers and resellers. The new law made several important improvements to accommodate the trend towards a finer division of the manufacturer. Specifically, he clarified the definition of manufacturer to include the manufacture, packaging, labeling, sterilization and final inspection of medical devices and added to the definition of manufacturer “engage in the design of devices”. medical devices and market the devices under their name ”(article ten). In addition, the law required those involved in the manufacture, import or maintenance of medical devices to recruit technicians according to the type of devices used (Article 15).
The law categorizes resellers as wholesale, retail, import, export, rental and service, and these resellers are required to apply to serve as medical device companies before undertaking such activities. (Articles 11 and 13)
II. Improve the regulation of risk classification before the marketing of medical devices
In principle, medical devices must be the subject of an inspection registration request; It is only after approval and licensing that it can be manufactured and imported. However, the new law simplifies this pre-market review process for low-risk medical devices. Instead of requesting inspection registration, the device list will suffice for several low-risk medical devices. Manufacturers must file an annual declaration of registration with the competent central authority each year to maintain its validity. (Articles 25, 28)
The issuance of licenses for medical devices is flexible as to its period of validity. The maximum validity period is 5 years and extensions can be applied before the expiration date. Each extension must not exceed 5 years. (Article 27).
III. Implementation of regulations on pre-market clinical trials of medical devices
Clinical trial institutions or trial sponsors submit an application for approval to the central authority before any clinical trial. Any adverse event during the trials must be reported to the authority within 7 days of becoming aware of these events. If security risks arise during the trial, it can be suspended or terminated (Articles 37, 38, 39).
To manage the risks, clinical trials on medical devices that carry insignificant risks as announced by the competent central authority are not required to submit requests for approval (Article 37).
IV. Improve post-market supervision on the safety of medical devices
The competent authority announces specific categories and articles of medical devices with restriction of their type of sale or supply in response to various new forms of sale of medical devices (Article 18). With respect to medical devices classified as a specific risk level as announced by the competent authority, medical device companies and medical establishments should establish data on the source and flow of their products to help trace and monitor products on the market (Article 19).
For product safety considerations, the manufacturer of medical devices must establish a quality control system and report to the competent central authority for inspection in order to obtain authorization before proceeding with manufacture (Article 22). Medical devices and their resellers announced by the competent authority must set up a quality distribution system that meets the distribution standards for medical devices, and obtain a distribution authorization before any wholesale, import or export (Article 24) . In addition, a communication protocol should be established for essential medical devices, especially when their manufacture, import ceases or supply is insufficient. (article 34)
To oversee the management of medical devices, taking into account the potential risk of certain medical devices, the competent authority may order medical device companies to execute a safety oversight plan on specified items at a time of their choosing. in order to monitor the safety of medical devices. Medical institutions provide assistance and provide all relevant data (Article 47). In addition, for the safety of its users, as soon as it becomes aware of a probable risk of bodily harm from a medical device, the authorized owner or the registrant of such devices must immediately take corrective measures and preventive measures and inform the competent authority (Article 49).
V. Criminal liability of serious offenders
Those who violate the law will be subject to administrative penalties depending on the nature of the violation, which may include fines; an order requiring corrective action within a limited timeframe; an announcement of the identity, name and details of the infringement of the offender; and license suspension or withdrawal (Articles 64 to 71). The following penal sanctions may apply to persons in serious breach:
1. Those who manufacture or import defective medical devices which lead to a misdiagnosis, or devices containing toxic or dangerous substances which cause bodily harm may be sentenced to a maximum of 5 years imprisonment, criminal detention or imprisonment. fine of up to NT $ 50 million, or both. Negligent violations can be sentenced to a maximum of 3 years imprisonment, criminal detention or a fine of up to NT $ 10 million, or both. (Article 60, paragraphs 1 and 3)
2. Those who knowingly sell, supply, transport, store, trade, transfer or display with the intention of selling defective medical devices may be sentenced to a maximum of 3 years imprisonment, criminal detention or a fine of up to NT $ 10 million. , or both. Negligent violations can be sentenced to criminal detention or a fine of up to NT $ 1 million, or both. (Article 60, paragraphs 2 and 4)
3. Anyone who abuses or uses without authorization the name, instructions or labels of a legitimate medical device can be sentenced to up to 5 years imprisonment, criminal detention or a fine of up to $ 20 million. NT, or both. Those who knowingly import, sell, supply, transport, store, trade, transfer or display with the intention of selling medical devices while being aware of the above violations may be sentenced to a maximum of 2 years imprisonment, detention criminal or fine of up to NT $ 10 million, or both. (Article 61)
4. Anyone attempting to sell or supply, manufacture or import unapproved medical devices or unregistered devices that should have been registered; and those who knowingly sell, provide, transport, store, trade, transfer or display with the intention of selling while being aware of the above violations may be sentenced to a maximum of 3 years imprisonment, criminal detention or a fine of up to NT $ 10 million, or both. (article 62)
5. In the event that those who, in the exercise of their duty, have violated the aforementioned offenses are the representative, agent, employee or any other member of the personnel of a legal person or a natural person , in addition to the penalties imposed on the offender, said legal / natural person will be liable to a maximum of ten times the fine provided for in all articles. (Article 63)
Annex: Compilation of relevant sub-laws authorized under the Act