Mandatory Reporting the Medical Device Supply Records: Took effect on July 01, 2020
The Ministry of Food and Drug Safety (MFDS) started putting into action of the law of 'Mandatory Reporting of the Medical Device Supply Records' from July 1, 2020, which mandates reporting of the medical device supply records by the Korean manufacturers, importers, and distributors. This rule was enacted to reflect the MFDS' intention of increasing the transparency of the medical device distribution and traceability of hazardous products.
The Korean manufacturers, importers, and distributors must put the supply records onto the governmental portal site regarding the information on the supplier, product information and etc. for the sold and/or leased medical devices.
This regulation is applied to the products with following schedule:
- Class 4: July 01, 2020
- Class 3: July 01, 2021
- Class 2: July 01, 2022
- Class 1: July 01, 2023
◈ Summary of what must be reported as the Medical Device Supply Records
Responsible parties for the reporting: Medical device manufacturers, importers, distributors, and lenders
Reporting deadline: Reporting must be done on a monthly basis by the end of the next month from the time when the medical device was supplied.
Contents: Information on the supplier and customer, product's UDI, date of supply, supplied amount, unit price of the product (only when the product was supplied to a hospital)
Method: Input the records to the governmental portal site at https://udiportal.mfds.go.kr
If such report is not implemented by the responsible party, an administrative sanction of a 15-day suspension of sales and a penalty of 500,000 KRW will be imposed.
In order to ease the burden on the medical device industry caused by the COVID-19 outbreak, a grade period of 6 months by the end of 2020 will be placed.