(1) Reasons for Proposal
As the Medical Devices Act was revised (Act No. 17248, proclaimed on April 7, 2020, and to be enforced on October 8, 2020), this amendment aims to improve and supplement some of the shortcomings that have emerged from the operation of the current system, including matters related to the designation, business scope, and operation of medical device safety information monitoring centers and standards, methods, procedures, etc., for the renewal of medical device manufacturing permits, etc.
(2) Major Provisions
A. Designation of medical device safety information monitoring centers (Article 59-3)
1) Since 2011, the Minister of Food and Drug Safety has designated a general hospital for each regional base as a medical device safety information monitoring center to actively cooperate with the National Institute of Medical Device Safety Information, which has, however, no legal basis and does not guarantee continuous and stable business implementation.
2) To support the collection of medical device safety information by the National Institute of Medical Device Safety Information, it aims to secure the continuity and stability of the business by providing a basis for designating and operating general hospitals as medical device safety information monitoring centers.
B. Renewal of medical device manufacturing permits, etc. (Article 62)
1) Although the existing Medical Device Act stipulated the renewal system such as manufacturing permits, etc., the renewal system was not properly operated because it did not specify the validity period. Due to this, even if a medical device is not manufactured or imported, the manufacturing permits, etc., remain effective, and thus unnecessary administrative capacity is wasted to manage it. In addition, it is difficult to produce appropriate statistics related to medical devices.
2) Thus, it aims to set the validity period for the renewal of medical device manufacturing permits, etc., to 5 years, prevent unnecessary wasted administrative capacity by prescribing procedures and methods for renewal, and promote the proper management of medical devices.
