(1) Reasons for Proposal
○ Request for addressing issues in the current medical device classification system found in the process of approval, review, and complaint management regarding medical devices (’17, Medical Device Management Division, Medical Device Safety Evaluation Division, Medical Device Evaluation Department, etc.)
- The classification system regarding separately managed products needs improvements for efficient safety management in consideration of product-specific characteristics.
(2) Major Provisions
○ Provisions newly inserted and strengthened (3 products)
- ‘Guide for medical use, invasive’ and ‘Implant, surgical, Guide for dental use’ are newly inserted, which were managed as ‘Guide for medical use’ [Class 1] and upgraded to Class 2. ‘Intraocular gas kit, retinal tamponade, ophthalmic’ [Class 3], which was autonomously managed, is newly inserted as a medical device product: these provisions are subject to review since they upgrade Class 1 products, which are to be registered as Class 2 products, which are subject to review for approval and render the self-managed product subject to approval, imposing additional responsibilities on those being regulated.
□ No provisions newly inserted or strengthened (6 products)
○ Insertion of ‘Continuous glucose monitoring systems, self-testing, in vivo,’ ‘Irrigation kit with salt powder, nasal, manually-operated,’ ‘Irrigation kit with salt powder, nasal, electrically-powered,’ ‘Cylinder cartridge for cylinder pump,’ ‘Splint, hallux valgus,’ and ‘Resin for cutting process’ is to subdivide products with no change in class: these are not subject to review since they do not restrict the rights of those being regulated or impose additional responsibilities on them.
□ Change of product names* or product definitions** (11 products)
○ Substitution of the names or definitions of some products with easier ones or clarification of the definitions.
* Administrator: Grade 5 Hong-Mo Seong (Medical Device Policy Division +82-43-719-3754), Grade 6 Yeong-Uk An (Medical Device Policy Division +82-43-719-3777), Grade 6 Se-Yun Cho (Regulatory Reform and Legal Affairs Office +82-43-719-1533)
(3)Amendment Details
Partial Amendment to the Regulations for Product Classification of Medical Device and Class by Product
Amend a part of the Regulations for Product Classification of Medical Device and Class by Product.
In A22030.02 of the Attached Table, change “Glucose monitoring systems, self-testing” and “self-testing” to “Glucose monitoring systems, self-testing, in vitro” and “self-testing, in vitro,” respectively, and “System for self-testing of blood glucose or blood ketones” to “System for in vitro self-testing of blood glucose or blood ketones with blood samples.”
Newly insert A22030.03 next to A22030.02 of the Attached Table as follows:
A22030.03 Continuous glucose monitoring systems, self-testing, in vivo [3] systems (with measuring instruments, sensors, and others) for continuous self-testing of glucose or ketones by inserting sensors or others into the body or attaching them to the skin or others without drawing blood.
In A35000 of Attached Table, change “Electrosurgical device” to “Electrosurgical and other surgical devices.”
In A38090.08 of Attached Table, change “Clips, mini-vascular’ to “Clips, mini-vascular, implantable.”
In A38090.09 of Attached Table, change “Clips, for aortic aneurysm” to “Clips, for aortic aneurysm, implantable.”
In A38090.10 of Attached Table, change “Clips, for cerebral aneurysm” to “Clips, for cerebral aneurysm, implantable.”
In A38090.11 of Attached Table, change “Clips, absorbable, surgical” and “absorbable instruments” to “Clips, absorbable, implantable” and “absorbable instruments, implantable,” respectively.
In A38090.12 of Attached Table, change “Clips, non-absorbable, surgical” and “non-absorbable instruments” to “Clips, non-absorbable, implantable” and “non-absorbable instruments, implantable,” respectively.
In A38170.04 of Attached Table, change “Clips, vena cava” to “Clips, vena cava, implantable.”
In A64050.01 of Attached Table, change “Guide for medical use” to “Guide for medical use, non-invasive” and “instruments for use” to “instruments for extracorporeal or non-invasive use. Dental instruments excluded.”
Newly insert A64050.02 next to A64050.01 of Attached Table as follows:
A64050.02 Guide for medical use, invasive [2] instruments for intracorporeal or invasive use to indicate the path and position of implants or instruments and the surgical site
Newly insert A65080.01 and A65080.02 next to A65070.01 of Attached Table as follows:
A65080.01 Irrigation kit with salt powder, nasal, manually-operated [1] kits of instruments for manual nasal irrigation and salt powder, KP grade or equivalent.
A65080.02 Irrigation kit with salt powder, nasal, electrically-powered [1] kits of instruments for electrical nasal irrigation and salt powder, KP grade or equivalent.
In A79030.02 of Attached Table, change “Intravascular administration set for fluid pump,” “for fluid,” and “fluid to the site in the fluid pump” to “electrical pump set for infusion of medicine,” “for infusion,” and “fluid or liquid medicine in the electrical pump set for infusion of medicine by interlocking,” respectively.
Newly insert A79040.02 next to A79040.01of Attached Table as follows:
A79040.02 Cylinder cartridge for cylinder pump [2] Special equipment used for supplying fluid or liquid medicine in the cylinder pump.
In A86010.01 of Attached Table, change “0.9% sodium chloride solution (medicine)” to “including 0.9% sodium chloride solution, KP grade or equivalent.”
Newly insert B03260.03 next to B03260.02 of Attached Table as follows:
B03260.03 Intraocular gas kit, retinal tamponade, ophthalmic [3] Intraocular instruments including gas such as sulfur hexafluoride (SF6), perfluoroethane (C2F6), and perfluoropropane (C3F8), and used for reattaching a detached retina to the choroid layer of the eye. Products with a gas-refillable container excluded.
Newly insert B05030.02 next to B05030.01 of Attached Table as follows:
B05030.02 Splint, hallux valgus [1] Instruments for realigning curled toes such as in hallux valgus
Newly insert C21040.01 next to C21030.01 of Attached Table as follows:
C21040.01 Implant, surgical, Guide for dental use [2] Materials and instruments used to map out the position of the implantation and indicate, on the basis of the mapping, the orientation, depth, and position of the implantation.
Newly insert C07070.02 next to C07070.01 of Attached Table as follows:
C07070.02 Resin, milling [2] Polymeric materials to be cut by computer-aided design and manufacturing units for production of inlays, dental implants, crowns, bridges, and copings. Complexes such as mineral fillers or mixed fillers included. (April 2, 2018)
Addenda
Article 1 (Effective Date) ① These regulations shall take effect from the date of promulgation.
② Notwithstanding Paragraph ①, these regulations shall take effect from two years after the date of promulgation in case of products categorized into newly inserted B03260 03 Intraocular gas kit, retinal tamponade, ophthalmic.
Article 2 (Special Cases concerning Conformity of Manufacturing and Quality Control Criteria) A party who has already registered as A64050.01 newly inserted A64050.02 or Guide for medical use, invasive or C21040.01 Implant, surgical, Guide for dental use may manufacture, import, and distribute the products until two years after the effective date without certification of the conformity to the criteria of Attached Table 2 or 4 of「Enforcement Rule of the Medical Devices Act」.
Article 3 (General Interim Measures) Permission, certification, registration, review of technical documents, and other actions taken under the existing「Regulations for Product Classification of Medical Device and Class by Product」before the effective date shall be deemed taken under the corresponding parts of the notification.
Article 4 (Interim Measures for Changes of Names and Definitions of Products)
① The products that have already been approved or reported under the existing provisions, if their names and definitions of products are changed under the notification, are deemed changed without specific procedure for change.
② Notwithstanding Paragraph ①, a party who has already registered as A64050.01 newly inserted A64050.02 Guide for medical use, invasive or C21040.01 Implant, surgical, Guide for dental use shall obtain the certificate of manufacturing and import of medical devices again in accordance with the definitions of the products in the notification from the director of the Medical Device Information and Technology Assistance Center within a year from the effective date.
Article 5 (Relationship with Other Notifications)
If existing provisions, while the notification is enforced, are mentioned in other notifications, it shall be deemed that the corresponding parts of the notification are mentioned.
