This Act is established to ensure the safety, effectiveness, and quality of medical devices to be used by citizens, to promote the health of citizens, and to improve management of medical devices.

For purposes of this Act, the term "competent authority" shall mean the Ministry of Health and Welfare at the central government level, the municipal governments at the municipal level, and the county/city governments at the county/city level.

The term "medical devices", as used in this Act, shall refer to instruments, machines, apparatus, materials, software, reagents for in vitro use, and related articles thereof, whose design and use achieve one of the following primary intended actions in or on the human body by other than pharmacological, immunological, metabolic, or chemical means:
1. Diagnosis, treatment, alleviation, or direct prevention of human diseases.
2. Modification or improvement of the structure and function of human body.
3. Control of conception.
Regulations governing the categories, risk classification, items, determination principles, and other related matters shall be established by the central competent authority.
Assistive devices covered by Subparagraph 2 of Paragraph 1 that are non-invasive, not expected to cause harm to the health of human body, and used without the assistance of medical personnel may be notified to the central competent authority for approval and exempt from being listed as medical devices of the preceding paragraph.
Assistive devices set forth in the preceding paragraph refer to appliances, equipment, instruments, and software that assist physically or mentally disabled persons to improve or maintain physical function and structure, to facilitate activity and participation, or to provide convenience to the attendance of their caregivers.

The term "investigational medical devices", as used in this Act, shall refer to medical devices that are used solely in clinical trials and whose therapeutic effect and safety have not been verified.

The term "medical device clinical trials", as used in this Act, shall refer to the systematic studies on the safety or effectiveness of medical devices carried out in human subjects by medical care institutions or institutions announced by the central competent authority (hereinafter referred to as "clinical trial institutions").

The term "medical device advertisements", as used in this Act, shall refer to the act of publicizing the therapeutic effect of medical devices by means of communications for the purpose of soliciting and promoting the sale thereof.
Interviews, news reports, or propaganda containing information that implies or suggests therapeutic effect of medical devices for the purpose of soliciting and promoting the sale thereof shall be regarded as medical device advertisements.

The term "labels", as used in this Act, shall refer to the words, graphics, or symbols displayed on a medical device or the packaging thereof.
The term "instructions", as used in this Act, shall refer to the related materials that describe information on product safety, effectiveness, and use of medical devices.

The term "defective medical devices", as used in this Act, shall refer to medical devices which fall within any of the following circumstances after inspection or testing:
1. The occurrence of misdiagnosis is prompted or toxic or hazardous substances are contained, resulting in harm to the health of human body.
2. The normal and reasonable use in accordance with directions indicated on the labels or instructions is liable to cause danger or harm to the health of human body.
3. The duration of validity or storage life has expired.
4. The performance or specification is inconsistent with the content that has been approved in registration, listed, or announced as set forth in Paragraph 2 of Article 30.
5. The preservation is not in accordance with the storage conditions approved in registration.
6. Foreign objects that affect product quality are mixed or packed.
7. Other defects announced by the central competent authority.

The term "medical device firms", as used in this Act, shall refer to medical device manufacturers or dealers.

The term "medical device manufacturers", as used in this Act, shall refer to businesses that fall into the following two types:
1. Engaging in the manufacturing, packaging, labeling, sterilization, or final inspection and release of medical devices.
2. Engaging in the design of medical devices and marketing the devices under their name.

The term "medical device dealers", as used in this Act, shall refer to businesses which engage in the wholesale, retail, import, export, rental, or repair of medical devices.

The term "medical institutions", as used in this Act, shall refer to institutions applied for operation by medical personnel specified in Paragraph 1 of Article 10 of the Medical Care Act in accordance with the relevant regulations of professions and occupation laws and have been approved for practice.