EMERGO SUMMARY OF KEY POINTS:

• South Korea’s MFDS has clarified new and upcoming requirements regarding unique device identification (UDI), KGMP quality system audits and medical device expenditure reports.
• UDI requirements will come into force on a rolling basis through 2022.
• Various KGMP audit requirements have been streamlined or eliminated for some device classes.

The South Korean Ministry of Food and Drug Safety (MFDS) has issued clarifications on medical device registration and quality system requirements whose enforcement dates are imminent.

Emergo consultants in Seoul report that South Korean regulators have updated the Medical Device Act No. 14330 as well as the Regulation on KGMP No. 2016-156  (links in Korean) to more fully explain rules for unique device identification (UDI), expenditure reports and Korea Good Manufacturing Practice (KGMP) quality system audit procedures.

MFDS rollout plans for UDI requirements

First, the MFDS has clarified plans to phase in UDI requirements for all classes of medical devices over the next several years, and further explained associated compliance obligations for registration holders.

“The current law for medical devices provides little basis for understanding a device’s status from its production or importation stage to its distribution stage,” says In-Wha Kim, Regulatory Affairs Specialist at Emergo’s South Korea office.

Therefore, according to Kim, MFDS will be introducing a UDI system, requiring manufacturers, importer and distributors to report supply histories, and establish a Medical Device Information Center according to a seminar the ministry held in January 2017.

UDI enforcement would come into effect in 2019 for Class IV and high-risk devices; 2020 for Class III devices; 2021 for Class II devices; and 2022 for low-risk Class I devices.

MFDS added the following specific clarifications to its UDI regulation:

• “UDI” has been formally defined, and UDI numbers and barcodes are to be marked on devices or device packaging in order to systematically manage devices within a standardized system.
• Device labeling must include UDI numbers as defined by the MFDS.
• Breakdown of the number of a manufacturer’s products provided to medical facilities, distributors and lenders are to be reported to MFDS to meet South Korea’s Enforcement Regulation on the Medical Device Act.
• MFDS will launch a Medical Device Information System (also known as the Medical Device Information & Technology Assistance Center or MDITAC) that will store and manage information on device registration, manufacturing, importation and distribution, and usage; registrants will be required to submit their device UDI numbers to the Medical Device Information System.

Adjustments to Korea Good Manufacturing Practice (KGMP) audits

Second, South Korean regulators have simplified audit procedures and documentation requirements for KGMP quality management system compliance. These changes took effect March 1, 2017.

KGMP audit changes include:

• KGMP audits for Class II devices may now be conducted solely by third party auditors, which may now issue KGMP certifications without MFDS involvement.
• Regulators have waived on-site audit requirements for limited timeframes in instances where a natural disaster makes visiting a site impossible or difficult.
• Grouping renewal audit requirements have improved whereby multiple KGMP audits may be grouped together regardless of individual certificates’ expiration dates.
• On KGMP certificates, device categories will now be stated in both Korean and English.

Expenditure report requirements spelled out

Finally, MFDS has explained how frequently South Korean market registrants must provide expenditure reports on how their devices provide economic benefits to healthcare providers and institutions.

Registrants must generate expenditure reports annually, within three months of their fiscal year ends. They must also retain these reports along with relevant supporting data for five years; South Korean regulators may request these reports at any time.

“It is not easy to distinguish or detect whether the provision of some economic benefit to a healthcare provider is related to promoting the sale of a device,” explains Kim. “As a countermeasure to this, medical device companies are obliged to prepare expenditure reports on providing economic benefits, which is intended to strengthen registrants’ own self-reporting and monitoring capabilities, and ensure more transparency in the market.”

According to MFDS, expenditure reporting requirements take effect on June 3, 2017.

Additional South Korean regulatory resources

For more information on South Korea’s medical device market, read our MFDS registration whitepaper, watch our video overview and download our regulatory process chart.