BioPlus Co., Ltd., a manufacturer specializing in fillers, obtained the Medical Device Single Screening Program (MDSAP) certification on 23 June.
The Medical Device Single Audit Program (MDSAP) is a system that certifies medical devices that meet the criteria requirements through a single review at the International Medical Device Regulatory Forum (IMDRF) for medical device safety and quality control.
The certification received through the British Royal Standards Institute (BSI) provides full or partial waivers of medical device certification audits in five countries, including the United States (FDA), Canada (MHLW), Japan (MHLW), Australia (TGA) and Brazil (ANVISA).
BioPlus Co., Ltd. obtained the MDSAP certification as the first domestic filler company and this reduces audit process, thereby significantly reducing the time and cost involved in the quality certification process for exporting products.
BioPlus Co., Ltd. is expected to accelerate the expansion of overseas market with international recognition for its excellent filler manufacturing system and technology.