Here is the Ministry of Food and Drug Safety Notice No. 2014-87 from South Korea.
South Korea MFDS is revising 「Regulations regarding Medical Device Products and Product Classification」 (Ministry of Food and Drug Safety Notice No. 2014-88, 2/12/2014) in part, and gathering consensus from the people. They are hereby giving a notice regarding the purpose, reasons for revision, and key details as following in accordance with Administrative Procedures Act Section 46.
This is a proposal for revision, therefore public feedback is expected.
1.Reasons for Revision
The raw materials such as DEHP, endocrine disrupter, which pose the safety concern are newly required for license/notification to prevent elements harmful to the public health. Moreover, the goal is to relax the regulatory requirements by adding mobile medical apps vendors to the exemption list of the medical device, and to seek improvements on the deficiencies in the procedures.
Definition of Active Implantable Medical Device and Notation of Application Form
- Active Implantable Medical Devices pose a greater threat as compared to other medical devices when side effects occur so that an action such as immediate recall is necessary. However, the management is inadequate in reality because they are not classified and managed regionally when the license is granted.
- Therefore, the definition of Active Implantable Medical Device is newly established, and it is required to notate “Active Implantable Medical Device” in the remark section of the application form when notifying for the license.
- It is expected to enable actions to be taken swiftly when side effects take place by independently managing the license status of Active Implantable Medical Devices.
Medical Device License, Subject of Restriction for Notification, and etc.
- According to Regulatory Rules Section 7.3 Paragraph 1.2, it is provided that the Minister of Food and Drug Safety may declare raw materials with issues of safety and efficacy to be restricted for license and notification.
- The raw materials that belong to phthalates class (only for SAP sets) such as mercury, asbestos, diethylhexyl (Bis-2-ethylhexyl phthalate, DEHP), dibutylpthalate (DBP), benzyl butyl phthalate (BBP), and etc. may be harmful to the human body; thus the license and notification are to be restricted.
- By restricting license/notification of the medical devices that contain raw materials with issues regarding safety/efficacy, it is expected to preemptively prevent elements harmful to the public health.
Enhancement of Procedures for Amending “Intended Use” of Medical Devices
- The regulation requires that license for amendment or notification for amendment be made when amendments are made to authorize/notify entries of products with manufacturing (importing) license/notification. However, unnecessary delay in processing and waste of administrative manpower are taking place because license/notification is newly required whenever there is an amendment of intended use. * New license (technical documentation 65 days) requires an additional 23 days as compared to amendment of license (technical documentation 42 days)
- Thus, the procedure shall be enhanced to require an amendment of license instead of a new license when there is a change in the intended use.
- It is expected to improve the satisfaction of applicants and the efficiency of administration by reducing the time necessary to process amendment of intended use.
Maintenance of Data Requirements regarding Clinical Studies
- The Data regarding clinical studies submitted at the time of license to the members of OECD (Organisations for Economic Co-operation and Development) and the data listed in SCI (Science Citation Index) need to be acknowledged as the data regarding clinical studies even though they do not contain the details of method for clinical studies, clinical results, clinical evaluations, and etc. ※ Difficulties to prove the number of clinical subjects and statistically valid clinical trials, or to verify the proven clinical significance.
- A question of equitability is raised regarding the data for clinical trials performed nationally. There is an irrationality that the data regarding clinical trials must be accepted even though there is no comparison of theses listed on SCI or the number of similar clinical trials is statistically insufficient for the number of clinical trials.
- It is expected to resolve the irrationality and the problem of equitability by allowing to submit the data for method of clinical trials, clinical results, and clinical evaluations even if they are the data regarding clinical studies submitted at the time of license to the members of OECD (Organisations for Economic Co-operation and Development) and the data listed in SCI (Science Citation Index).
Exemption of Notification for Medical Device Vendor of Medical Application (App)
- Presently, vendor notification is exempt for only 5 types including capillary thermometer and automatic electronic sphygmomanometer. There is the irrationality that medical apps incorporated into the consumer electronics such as a mobile phone must file the vendor notification. ※ Vendor notification of medical devices is required for vendors of communication devices (27,846 as of 2012).
- Exemption list is expanded for vendors of mobile medical app used for self-diagnostic purpose and product incorporating mobile medical app.
- It is expected to improve the accessibility for consumers and the satisfaction of civil applicants to vitalize the medical device industry
For those organizations and/or individuals with any opinion they can submit the opinion in writing by enclosing the following information and send it by 2/28/2014 to Minister of Food and Drug Safety (postal code: 363-700, address: Choong-Chung Book-Do Chung-Won Kook Oh-Song Eub Oh-Song Saeng-Myung 5th Street 303 Kookdo Purumiru Building 4th Floor Ministry of Food and Drug Safety (Annex) Re: Medical Device Policy Making Department, phone: 043-230-0415, fax: 043-230-0400, email firstname.lastname@example.org)
See the original notice here.