Anwendungsbereich des Regulatory Essentials
Geltende Rechtsvorschriften:
SECTION 2 Import Business
Article 15 (Import Business Permission, etc.)
(1) A person who intends to engage in the business of importing medical devices shall obtain import business permission from the Minister of Food and Drug Safety.
(2) A person granted import business permission under paragraph (1) (hereinafter referred to as "importer") shall obtain import permission or import certification, or file an import notification with regard to medical devices that he/she intends to import, according to the following classifications:
1. For medical devices designated and publicly notified by the Minister of Food and Drug Safety and unlikely to pose any risk to human safety and health even upon occurrence of a failure or malfunction because of marginal potential risk to human health: Import permission, import certification , or import notification, by item category;
2. For any medical device other than those falling under subparagraph 1: Import permission, import certification, or import notification, by item.
(6) The provisons to Article 6 (1), Article 6 (5), (7) through (10), Articles 6-2, 6-3, 7 through 9, 11 through 13, 13-2, and 14 shall apply mutatis mutandis to medical devices imported pursuant to paragraphs (1) through (5) and the importers of such medical devices. In such cases, the term
"manufacturing" shall be construed as "import;"
"manufacturing business permission" as "import business permission;"
"manufacturing permission" as "import permission;"
"manufacturing certification" as "import certification;"
"manufacturing notification" as "import notification;"
"production management" as "import management;" and
"manufacturer" as "importer,"
respectively.
The Enforcement Rule details the regulation of the Medical Devices Act:
- Application for Manufacturing Business Permission
- Procedures of Manufacturing Permission, Manufacturing Certification, or Manufacturing Notification
- Application for Import Business Permission
- Application for Import Permission
- Exemption from Permission for Medical Device Import Business
- Notification of Repair Business
- Management of Medical Devices Subject to Tracking Management
- Procedures for Recall of Harmful Medical Devices
Regulates the work of the Korean Medical Devices Committee.
Regulations on medical device licensing, notification, examination, etc. - Content:
Chapter 1 - General (Purpose, Definitions etc.)
Chapter 2 - Medical Device Items and Items Authorization Certification Notification
Chapter 3 - Medical Device Authorization Certification Application and Declaration Item Details, etc.
Chapter 4 - Examination of technical documents, etc.
Chapter 5 - deleted
Chapter 6 - Designation of Rare Medical Devices, etc.
Chapter 7 - deleted
Chapter 8 - Step-by-Step Audit Operation
Chapter 9 - Designation of medical devices exempt from sales business notification
Chapter 10 - Approval of Medical Devices for Exhibition Purposes
Chapter 11 - Allowable range for improving the performance of medical devices
Chapter 12 - Review of Medical Device Eligibility
Chapter 13 - Supplementary Provisions