MFDS Improves Bio and Health Regulations... Easier Medical Device Software Updates

Transition to Negative Regulation for Medical Device Software Change Approval System
Advancing Six Tasks Including Relaxation of Sample Storage Obligations for Imported Pharmaceuticals

[Asia Economy Reporter Kim Young-won] The Ministry of Food and Drug Safety (MFDS) will ease regulations on medical device software updates and address difficulties faced by companies in the bio-healthcare sector during the approval process.

On the 13th, the MFDS announced that following the confirmation of the "Regulatory Improvement Plan for New Industry Companies" by the Regulatory Reform Committee on the 10th, it will pursue six tasks to improve regulations in the bio-healthcare new industry sector.

Accordingly, once the revision of the notification is completed next month, only significant changes such as 'upgrades' involving core performance changes in medical device software will require approval procedures, while other matters will be subject to a 'negative regulation' system where companies take prior action and report afterward.

Previously, companies had expressed concerns about the burden of updating medical device software. Due to the nature of medical device software, updates such as security functions are frequent, but these were not considered 'minor changes,' resulting in an average of 42 days and approximately 1 million KRW in fees. This measure will reduce costs and time for companies and enable medical sites to respond quickly if problems occur during the use of medical device software.

For 'traceability management target medical devices,' which require material identification due to possible side effects or defects during use, the reporting method will be improved from reporting all monthly supply details and production/distribution records to exempting production/distribution record reporting for items included in the supply details report. Previously, companies pointed out that overlapping items such as model names in supply details and production/distribution records increased their workload.

The obligation to store samples of imported pharmaceuticals will also be relaxed. Imported pharmaceuticals require importers to store samples equivalent to twice the test quantity to identify causes in case of safety issues. However, for drugs imported in small quantities such as anticancer drugs and rare medicines with limited supply and demand, there were concerns that the storage obligation prevented supply to patients in urgent need. The MFDS plans to ease the sample storage obligation after conducting a status survey on import and storage management of these drugs by November.

Additionally, from December, conditional approval for pharmaceutical manufacturing facilities will be allowed even in leased buildings. Previously, conditional approval was only possible when using newly constructed buildings with land ownership for pharmaceutical manufacturing facilities. There was controversy over fairness as conditional approval was not granted for existing buildings if leased, and the MFDS has decided to relax the approval requirements.

Other tasks include allowing egg sorting and packaging businesses to sell eggs sorted and packaged directly without reporting as collection and sales businesses, and newly designating enteric capsule raw materials as food additives to enable their use in health functional foods.

An MFDS official stated, "We will continue to promote regulatory improvements by expanding the comprehensive negative regulation system to strengthen private autonomy and responsibility, striving to create tangible results that the public and companies can feel."

This content was produced with the assistance of AI translation services.