Unless otherwise specified, those other than medical device firms shall not engage in the business activities specified in Article 10 and Article 11.
Any business with the intent to become a medical device firm shall file an application with the municipal or county/city competent authority for approval and registration, and shall start the operation only after having obtained the business permit. In case there are any changes made in the particulars registered, the firm shall apply for change of registration.
Medical device firms shall manufacture, sell, or supply medical devices at the registered place. Those who set up a separate manufacturing facility or business establishment shall file a separate application for medical device firm registration in accordance with the provisions of the preceding paragraph; however, those announced by the central competent authority shall not be required to apply separately for a medical device dealer permit at the business establishment or for selling or supplying medical devices at the registered place.
If the medical device firms set forth in the second paragraph do not have any company registration or business registration, they need to submit a consent letter from the competent authority of the target business.
Medical device firms set forth in the second paragraph shall join the trade association in accordance with the Industrial Group Act or Commercial Group Act.

Those applying for being registered as a medical device manufacturer may also engage in such business as wholesale, retail, export, rental, or repair of its self-manufactured medical devices that have been listed or approved, or import of raw materials for their own use, without applying for a medical device dealer permit.
Pharmacies may concurrently engage in the retail business of medical devices of the classes announced by the central competent authority. Those who concurrently engage in the retail business of medical devices are applicable to the provisions governing the medical device dealers set forth in this Act, but may be exempted from applying for a medical device dealer permit.
Medical institutions for the necessity of conducting business may supply medical devices related to the business and may be exempted from applying for a medical device dealer permit. However, those who supply medical devices for patient use not as conducting business but for the sale or retail thereof shall nevertheless file an application for medical device firm registration in accordance with the provisions of Paragraph 2 of Article 13.

Medical device manufacturers and dealers engaging in the import or repair shall employ qualified technicians according to the categories of medical devices.
Regulations governing the categories of medical devices, qualifications and proportions of technicians, the number of hours in education and training courses referred to in the preceding paragraph, and other related matters shall be established by the central competent authority.
If qualified technicians employed by medical device manufacturers and dealers engaging in the import or repair as specified in the first paragraph cannot perform their tasks due to dismissal, resignation, or other reasons and replacements are not employed separately, the competent authority shall order the medical device manufacturers and dealers to make corrections within a time period. Those who fail to make corrections within the time period shall immediately cease the manufacture, import, or repair of medical devices.

To apply for suspension of business, medical device firms shall hand in medical device business permits and medical device licenses to the municipal or county (city) competent authority, who is to note clearly on business permit the reason and term of suspension and to return them once the resumption of business is approved. Each period of suspension shall not exceed one year.
Medical device firms shall apply for resumption, continued suspension, or termination of business before the period of suspension expires. For those who fail to apply upon the expiration period and after being verified by the municipal or county (city) competent authority that no business is actually in operation at the original address, the original issuing competent authority shall cancel their related permits and licenses.
When medical device firms apply for termination of business, medical device business permits and medical device licenses they have obtained shall be handed in at the same time for cancellation. Those which are not handed in for cancellation shall be cancelled by the original issuing competent authority.
For those who violate the provisions of this Act and are subject to suspension of business imposed by the competent authority, their permits and licenses shall be handed in, noted clearly, and returned in accordance with the provisions of the first paragraph.

Medical device firms shall not purchase or rent medical devices that have not been registered and approved or listed or are supplied by non-medical device firms.

The central competent authority may announce categories and items of specific medical devices with restriction on their sale or supply type according to the risk of using such medical devices.

For medical devices with certain risk class as announced by the central competent authority, medical device firms and medical institutions shall establish and maintain data on direct supply sources and flow of products.
For product items announced by the central competent authority, data established and maintained according to the preceding paragraph shall be reported to the central competent authority.
Regulations governing the scope, methods for establishment and maintenance of data, retention period, report contents and methods referred to in the preceding two paragraphs, and other matters to be complied with shall be established by the central competent authority.

The facilities, equipment, and sanitary conditions of medical device manufacturers shall comply with the Establishment Standards for Medical Device Manufacturers.
The Establishment Standards for Medical Device Manufacturers set forth in the preceding paragraph shall be jointly prescribed by the central competent authority and central industry competent authority.

Medical device manufacturers in Subparagraph 1 of Article 10 shall carry out factory registration pursuant to the Factory Management Act, except when exemption from factory registration is allowed pursuant to the Factory Management Act, or if such manufacture, as approved by the central competent authority, is for research and development purposes.

Medical device manufacturers shall establish a medical device quality management system governing the on-site facilities, equipment, organization and personnel, production, quality control, storage, logistics, customer complaints, and other matters and shall comply with the quality management system regulations.
Medical device manufacturers shall establish a medical device quality management system in accordance with the provisions of the regulations set forth in the preceding paragraph, and the manufacture may only begin after receiving a compliance inspection by the central competent authority and obtaining a manufacturing license. However, product items announced by the central competent authority shall not be required to obtain a manufacturing license.
The provisions of the preceding two paragraphs shall apply mutatis mutandis to overseas manufacturers importing medical devices, and the central competent authority shall send personnel to the premises of such overseas manufacturers for inspection on a periodic basis or as necessary.
The quality management system regulations set forth in Paragraph 1 and regulations governing the content and methods of inspection, the requirements, procedures, review, issuance, validity period, change, revocation, or cancellation of approval referred to in Paragraph 2, and other matters to be complied with shall be established by the central competent authority.

Medical device manufacturers shall not commission other manufacturers to manufacture or accept the commissioning to manufacture medical devices, unless otherwise approved by the central competent authority.
Medical device dealers shall not manufacture medical devices. However, this shall not apply to those approved by the central competent authority to commission other medical device manufacturers for the manufacture.
Regulations governing the application documents, product liability, contractual provisions, labeling, packaging for the commissioning of manufacture referred to in the preceding two paragraphs, and other operation related matters to be complied with shall be established by the central competent authority.

For medical devices announced by the central competent authority and their dealers, a medical device good distribution system shall be established to govern the product storage, distribution, services, personnel deployment, and other related operational matters, and shall comply with the regulations for good distribution practice of medical devices.
Medical device dealers shall set up a good distribution system of medical devices in accordance with the regulations set forth in the preceding paragraph, and the wholesale, import, or export may only begin after receiving a compliance inspection by the central competent authority and obtaining a distribution license.
Regulations for the good distribution practice set forth in Paragraph 1, and regulations governing the content and methods of inspection, the requirements, procedures, review, issuance, validity period, revocation, or cancellation of approval referred to in the preceding paragraph, and other matters to be complied with shall be established by the central competent authority.