1. Reasons for Amendment
The
Amendment aims to harmonize with international standards by expanding product
groups based on the risk level and manufacturing process, etc. of medical
devices. It establishes a quick examination system by combining requirements
for documents containing similar information and otherwise streamlining the
submission process, and switching to a sole examination by the quality control
examination agency, thereby aiming to reinforce medical device quality control.
2.
Major Provisions
A. Clearly prescribe that convergent
medical devices shall be subject to examinations for compliance, etc. with Good
Manufacturing Practice for Medical Devices (Articles 2 and 4, Article 6,
attached Forms 1, 2, 2-2, 3, and 4)
Clearly
prescribe that where a drug, etc. and a medical device form a combined or
complex structure whose main function corresponds to that of a medical device,
it shall be subject to examinations of compliance, etc. with Good Manufacturing
Practice for Medical Devices.
B. Expand medical device product groups
(Article 4 (1) 2, attached Table 3)
Expand
from 26 to 64 product groups based on risk levels and manufacturing processes.
C. Convert the joint examination by the
Regional Food and Drug Administration and the quality control examination
agency to a sole examination by the quality control examination agency
(attached Table 4)
Prescribe
that document screenings for Class 3·4 address changes and regular
examinations, and document screenings and on-site investigations of medical
devices for export, shall be conducted solely by the quality control
examination agency.
D. Streamline document
submission requirements (Article 7)
Ensure
the reliability of recognition of GMP compliance by combining current
requirements for documents containing similar information and otherwise
streamlining the information submission process.
E. Clarify the examination procedure,
including recognition of compliance with Good Manufacturing Practice for
Medical Devices (Article 8)
Amend
provisions prescribing that documents submitted when applying for an
examination for recognition of compliance with Good Manufacturing Practice for
Medical Devices shall be checked and accepted if free of flaws, to instead
require the documents to be checked within five days.
