South Korea Expanding Tracking System, Revising Quality Standards

The South Korean government has drafted a regulation that would expand its medical device tracking system to include 24 additional types of products.

According to a pre-legislation notice released by the Ministry of Food and Drug Safety, manufacturers of vascular grafts, implantable insulin pumps and artificial joints and 21 medtech products will now have to submit tracking information to an electronic MFDS database.

The move is drawing criticism from industry quarters. AdvaMed says South Korea’s regulatory officials already audit manufacturers and importers to verify sales and other information and check if they are complying with relevant device tracking regulations. The proposed regulation would add burdensome administrative processes without commensurate benefits, spokesman John Dobson said.

MFDS also plans to update its manufacturing and quality control standards to establish screening methods for on-site inspections, including conformity assessments.

The change would allow the ministry to issue interim certificates of compliance with Korean good manufacturing practices following a document review, in the event that an on-site inspection on device factories is necessary but unfeasible due to a natural disaster or war, explains Kim.

With an interim certificate, companies could distribute devices manufactured at a KGMP-expired factory on the condition that the products were tested in Korea and that the test reports were submitted to MFDS. Investigators would inspect the factory once the hindrance was eliminated, Kim adds.

AdvaMed called the proposal a positive step, saying it would ease the cost of on-site audits by switching to a paper format.

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