Items	Issues	Recommendations
Reimbursement of medical disposables	Medical disposables are grouped per category and get same reimbursement independent from quality and safety for medical staff / patient.	Adapt international standards for quality and differentiate reimbursement for high quality / safety vs low quality / safety
More active participation of industry in task forces established by MOH to draft and revise legislation	We observe that today participation is very much ad hoc and driven by the initiative of industry leaders, rather than based on a pro active and structural approach by the appointed Government entities and work committees.	European companies can add value by sharing relevant existing research and working documents used to draft legislation and standards by European agencies. Despite repeated offers from EUCCK, no concrete invitation for participation has been obtained.
Recognition and ability to submit existing test reports with European FDA to facilitate and speed up the approval process in Korea	The current application process may require re-processing of test results already submitted previously to European agencies. Where there is an overlap in requirements, these results should be able to be resubmitted. The latest reply of KFDA has not addressed this specific issue. There is now in Europe the LNE-GMED that is a specific organization to certify medical companies. G-Med certifications are considered now the toughest in the world. This organization can visit any medical factory without prior notice and order it closed the very same day if the inspection reveals dysfunctions in the quality system. From what we have heard the American FDA recognizes G-Med certification but Korean authorities don't recognize it.	EUCCK proposes that Korean authorities should recognize G-Med certification.
"De-criminalization" of regulatory affairs	All violations of compliance, even where these are not hazardous to health or are purely administrative of nature without violating actual standards, are currently penalized under the criminal code.	Administrative fines should be levied rather than criminal prosecution for afore mentioned breaches.
Registration item by item	The current regulations ask for implant products to register all items one by one and requires specific engineering drawings for all items. This is often useless in term of safety and represents a clear obstacle to trade as suppliers can refuse to provide such confidential data	The certification should be oriented to the quality control system of the company rather than item by item.
GIP application	KFDA revised in May 2004 the Medical Device Law, requiring importers to apply for GIP and performing in house quality inspection following the specifications and test methods of the approved technical documents. The importers should perform on each batch all tests listed in the specifications. For products imported from manufacturers having GIP, i.e. ISO 9001 and/or ISO 13485, this expensive testing is done already at the manufacturer and therefore not bringing any value if repeated by the importer.	In consequence, EUCCK proposes to maintain the current regulation of exemption for those products.