South Korea, Malaysia Introduce Medical Device Regulatory Changes
By Jof Enriquez,
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Government regulators of medical devices in South Korea and Malaysia have introduced changes to pre-market and post-market requirements, respectively.
According to Emergo, South Korea's Ministry of Food and Drug Safety (MFDS) now is requiring manufacturers of Class IV devices to submit mandatory Summary Technical Documentation (STED) with their registration applications. Those registering Class I, II, and III devices can opt to submit STED documentation on a voluntary basis.
In addition, MFDS is requiring Class III and IV device registrants to comply with new electronic safety compliance standards, incorporating IEC 60601-1 3rd Edition, starting June 2014. Class II devices had until June 2015, and Class I devices have until June 2016 to comply with the new rule.
MFDS also has added 90 products to the "cell manipulating kit for medical use" category, downgraded "dental color measuring" devices from Class II to Class 1, and changed the definitions for 108 medical devices, according to the Emergo report.
Like South Korea, Malaysia has introduced changes to registration requirements, extending device registration in that country from July 1, 2015 to June 30, 2016. Under the order, device registrants who filed an application with Malaysia's Medical Device Authority (MDA) within the grace period "may continue to import, export or place in the market the medical device pending determination of the application for registration."
MDA also has introduced additional post-marketing guidelines in Malaysia, covering complaint handling and field corrective action (FCA). These documents are designed to guide industry in complying with Malaysia's Medical Device Act 2012 (Act 737) and related laws.
According to RAPS, the pair of new draft guidance documents comes three years after the enactment of the aforementioned legislation covering Malaysia's medical device industry, and one year after MDA posted several policies and implemented rules of the law.
The first guidance, pertaining to complaint handling, requires manufacturers to report to MDA complaints concerning death or serious injuries arising from the use of medical devices, pursuant to the Medical Device Act. These mandatory reports should contain complete information regarding the product in question, incident description, and other relevant data. The guidance provides a process flow chart for handling medical device complaints.
The second guidance, covering field corrective action (FCA) requirements, details how manufacturers should assess the need for an FCA and, if started, how to file the subsequent field safety notification and FCA reports with the MDA within 30 days. The document outlines the information to be included in those reports, and provides field safety notice templates that establishments can use to communicate with customers.
MDA is receiving public comments on both guidance documents through July 10, 2015.