Obtained MDSAP certification which is given to five advanced countries for the first time in the filler industry of Korea
Filler manufacturer Bioplus Co., Ltd. obtained the MDSAP certification on June 23, an international medical device quality review system.
The Medical Device Single Audit Program (MDSAP) is a system that certifies medical devices meeting the criteria requirements through a single review by the IMDRF for medical device safety and quality control.
This certification, which was obtained through BSI (British Association of Standards and Technology), will exempt all or part of the screening process for medical devices in five countries, including the U.S. (FDA), Canada (Health Canada), Japan (MHLW), Australia (TGA) and Brazil (ANVISA).
By obtaining MDSAP certification for the first time in South Korea’s filler industry which means to obtain certification for each country at once, Bioplus Co., Ltd. can now significantly reduce the time and cost of quality certification procedures for exporting its products.
Bioplus Co., Ltd. is expected to step up efforts to expand its overseas markets as it is internationally recognized for its excellent filler manufacturing system and technical skills.