Devicemakers seeking to register products in South Korea say new regulations requiring them to first obtain a Korean good manufacturing practice certificate could delay product launches.
The new rules, which take effect Jan. 29, 2016, add an additional step to the process of getting a device on the market, says Jon Dobson, spokesman for U.S. industry group AdvaMed. Currently, companies register a product first and then get a KGMP certificate and reimbursement concurrently.
Under the new rules, the process will entail getting KGMP, then registration and then reimbursement. The Ministry of Food and Drug Safety has also set KGMP compliance deadlines for in vitro diagnostic devices. Higher-risk Class 3 and 4 IVDs must meet KGMPs by Nov. 10, while Class 2 IVDs have until Nov. 11, 2016.
Stewart Eisenhart, senior regulatory analyst with Emergo Group, says affected manufacturers should apply for KGMP certification at least 10 months ahead of the deadlines, as the certification process involves multiple steps.
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