NEWS

2019.12.30

MDSAP certified

Here to announce that Hsiner has obtained MDSAP certificate.



MDSAP - Medical Device Single Audit Program
To conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. (refer to following regulatory authorities) You can download the soft copy of certificate via link: http://www.hsiner.com/en/download/index.aspx

Australia:
 Therapeutic Goods (Medical Devices) Regulations 2002: Schedule 3, Part 1 - Full Quality Assurance System

Brazil:
 RDC ANVISA n. 16/2013 - Good Manufacturing Practices
 RDC ANVISA n. 23/2012
 RDC ANVISA n. 67/2009 - Vigilance

Canada:
 Medical Device Regulations SOR/98-282, Part 1

Japan:
 MHLW Ministerial Ordinance No.169 (2004) as amended by MHLW Ordinance No. 128 (2014) Articles 4 to 68
 Japan PMD Act (as applicable)

United States:
 21 CFR Part 803 - Medical Device Reporting
 21 CFR Part 806 - Reports of Corrections and Removals
 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing
 21 CFR Part 820 - Quality System Regulation