1. Reason for amendment

With the Medical Devices Act amended to improve the post-marketing surveillance system and apply the medical device sealing system, the aim is to set forth the matters required for execution thereof and to improve the insufficiency in the acts and subordinate statutes by improving facility standards for S/W medical device manufacturers.

2. Main content

A. Approval, etc. of the subjects to be exempted from post-marketing surveillance and surveillance plans (Articles 18 and 18-2 to 18-4 of the draft)

1) With the Act amended (Act No. 18446, promulgation on August 17, 2021, enforcement on February 18, 2022) so that “the term of re-examination” is changed to “post-marketing surveillance,” generic medical devices equivalent to the original medical devices for re-examination under post-marketing surveillance may also be surveilled, and medical devices such as newly developed medical devices posing low hazard to human bodies to be designated by the Ordinance of the Prime Minister are exempted from post-marketing surveillance, there is a need to reflect the revised contents to the lower acts and subordinate statutes and establish the details to be delegated.

2) As the subjects to be exempted from post-marketing surveillance are defined as Grade 2 and newly developed medical devices and medical devices with sufficient experience in overseas use, the manufacturers and importers of medical devices subject to post-marketing surveillance shall establish post-marketing surveillance plans for approval by the head of MFDS, regularly submit the post-marketing surveillance result, etc. following approval of the post-marketing surveillance plans (every six months for the first year, every year after one year). Thus, the clarity of the acts and subordinate statutes is guaranteed, and predictability is expected to be improved.

B. Establishment of condition for designating the education institutions of quality managers and administrative disposition standard in Appendix Table 9 (Articles 14 to 15, Attached Table 9 II Individual standard, and Form 11)

1) It is necessary to assign liability to quality managers of medical devices so that, if they did not complete the education, they cannot perform their work; the basis for the matters to be followed by quality manager education institutions and for sanctions against violation are provided (Act No. 18319, promulgation on July 20, 2021, enforcement on January 21, 2022) to establish obligatory matters delegated to the lower acts and subordinate statutes and disposition standard, etc.

2) The quality manager education institutions are expected to submit education master plans every year and establish the education operation standard and education plans. As such, the legal effectiveness will be guaranteed, and quality manager education is expected to become substantial by establishing a disposition standard for violation of matters needed to provide education such as issuance of false certificates or violation of obligatory matters.

C. Establishment of subjects to be sealed and disposition against violation, etc. (Article 45-4 and Attached Table 8 of the draft)

1) With the Act amended (Act No. 18319, promulgation on July 20, 2021, enforcement on January 21, 2022) so that, when manufacturers or importers of medical devices—such as medical devices to be inserted into human bodies and medical devices that may become contaminated or deteriorate during distribution—designated by the Ordinance of the Prime Minister intend to manufacture, import, or sell the corresponding medical devices, the containers or packages are sealed, there is a need to define the subjects to be sealed according to the delegation under the lower acts and subordinate statutes.

2) Therefore, the clarity of the acts and subordinate statutes will be guaranteed, and predictability is expected to be improved by defining the syringes, needles, and contact lenses, which are generated in many cases, among the medical devices to be inserted into or to come in contact with the human body, and distilled medical devices that may cause issues in case of sale with subdivision as medical devices to be sealed.

D. Improvement of facility standards, etc. of S/W medical device manufacturers (Articles 26(1) and 26(3) and Attached Table 2 of the draft)

1) Traditional medical devices such as machines, devices, apparatuses, materials, etc. are equipped with facilities such as workplaces, laboratories, warehouses, etc. and manufacturing and QC systems for manufacture and import, but S/W medical devices are manufactured in virtual form through computed information processing using programs without going through processes such as raw material warehousing, manufacture, production, and shipment, etc.; since they do not require the spatial concept of facilities, they need to be exempted from the liability for being equipment of facilities in the spatial concept.

2) Therefore, it is necessary to exempt the manufacture of S/W medical devices from the liability for being equipped with workplaces, laboratories, and warehouses and to make improvement for the free configuration of places, facilities, and equipment to establish and execute quality management systems for manufacturing S/W in order to operate the regulation rationally.