Korea (MFDS)
Purpose
Domestic medical device notification, certification and licensing regulates manufacture, import, repair and sale to manage devices efficiently and contribute to public health (Medical Device Act and related MFDS rules).
Overview
Anyone who manufactures, imports, repairs, sells or leases medical devices as a business must obtain notification, certification or licensing before domestic sale.
Who must comply
A “medical device handler” means any of the following who handles devices in the course of business and has obtained permission or filed notification under the Act:
- Medical device manufacturer
- Medical device importer
- Medical device repairer
- Medical device seller
- Medical device lessor
Required documents
Class 1 notification
- Notification form (MD enforcement rules Annex 7)
- Intended use per product classification tables
- Full-process outsourcing: consignee qualification proof
- Product-line notification: indicate product line on the form
* Class 1 devices not substantially equivalent to an already licensed/notified product require MFDS licensing.
Class 1 change notification
- Notification form (Annex 7)
- Outsourcing: consignee qualification proof
- Minor changes: minor change report within 30 days or annual window to regional MFDS office
- Transfer of business: minor change report with contract and name changes
* Changes registered on the e-Government portal are deemed filed.
Identical product – Class 2
- Certification/licensing application (Annex 3/5)
- Technical file aligned with previously licensed product
- GMP conformity certificate for the product or identical product line
- Manufacturing and sales certificates, IFU
- Notarized manufacturing site certificate
* Since 29 Jan 2016, applicants must have required facilities and QMS in place before applying.
Equivalent announced product – Class 2
- Certification/licensing application (Annex 3/5)
- Test report from MFDS-designated testing body
- GMP conformity certificate
- Consignee proof if fully outsourced
- Substantial equivalence comparison table
Class 3 and 4
- Licensing application (Annex 3)
- Technical file review notice and clinical/technical documentation
- Consignee proof if fully outsourced
* Technical file review notice must be issued within the last two years.
Remarks
Article 51 (Penalties)
- Any person who falls under any of the following shall be punished by imprisonment for not more than five years or a fine not exceeding 50 million won.
- A person who obtained permission, certification or filed a report by false or other improper means
- A person who violated Article 26(1)
- A person who obtained renewal by false or other improper means