South Korean Medical Device Regulators Ban Some Raw Materials
Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
South Korea’s Ministry of Food and Drug Safety (MFDS) identified certain raw materials prohibited from use in medical device production.
According to Article 5 of the amended MFDS regulation, the following materials may no longer be used in the production of medical devices:
- Mercury, except in devices used for dental applications
- Asbestos
- Phthalates within intravascular administration products, including 2-ethylhexyl phthalate (DEHP), dibutyl phthalate (DBP) and benzyl butyl phthalate (BBP)
Starting January 1, 2015, South Korean regulators will prohibit the manufacture, importation, sale and use of all devices currently registered with MFDS that use any of the raw materials identified.
Related: South Korea Regulators Scale Back KGMP Inspection Requirements