Key Changes to South Korean Medical Device, IVD Regulations Set for 2015

South Korean medical device regulators will implement significant changes affecting compliance requirements for medical device and in vitro diagnostic (IVD) registration as well as for Korean Good Manufacturing Practice (KGMP) audits over the course of 2015.

South Korea MFDS updates KGMP and IVD requirements

According to Emergo consultants in Seoul, officials at the South Korean Ministry for Food and Drug Safety (MFDS) have announced (link in Korean) on January 28, 2015 that market registrants must obtain KGMP certification earlier in their regulatory approval process than has previously been the case. Under the new regulatory pathway, applicants must undergo KGMP audits and certification at the beginning of their registration processes, whereas under the existing registration system, applicants must obtain KGMP certification after their registrations have been finalized by MFDS.

The current MFDS regulatory pathway:

  1. Submit registration application
  2. Device approval and license issued
  3. KGMP audit
  4. KGMP certificate issued
  5. Device may now be commercialized

The new regulatory pathway:

  1. KGMP audit
  2. KGMP certificate issued
  3. Registration application and KGMP certificate submitted
  4. Device approval and license issued
  5. Device may now be commercialized

Following the MFDS announcement, a one-year grace period is given for medical device manufacturers to come into compliance with the new requirements (Jan. 29, 2016).

New unit MDITAC for low-risk device registration

South Korean regulators are also launching a new MFDS unit, the Medical Device Information & Technology Assistance Center (MDITAC), that will focus on oversight of low-risk medical devices. The launch of MDITAC is set for July 29, 2015, and will enable MFDS to focus its resources on administration of higher-risk devices marketed in South Korea.

IVDs to be regulated as medical devices

As a reminder, the MFDS announced in May 2014 that oversight of IVD products in South Korea would shift from the country’s Pharmaceutical Affairs Law to its Medical Device Act, essentially regulating IVDs as devices rather than drugs.

This shift will require IVD devices and reagents to be registered as medical devices, and that IVD manufacturers comply with KGMP quality system requirements as well. Higher-risk Class 3 and 4 IVD products must come into KGMP compliance by November 10, 2015, while lower-risk Class 2 IVDs must comply by November 11, 2016.  Affected manufacturers should apply for KGMP certification at least 10 months prior to these compliance deadlines, as the certification process involves multiple steps.

MFDS has not yet published official guidelines for the changes listed above, but Emergo consultants in Korea are monitoring the situation and will provide updates as they occur.

 

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