MDSAP Notice

Thursday December 6, 2018

MDSAP Notice Important Update on MDSAP with regards to CHS and our products.

December 2018

 

BACKGROUND

The Medical Device Single Audit Program (MDSAP) was initiated at the International Medical Devices Regulators Forum's (IMDRF) inaugural meeting in Singapore in 2012.

 

The program was designed and developed so that a single audit, performed by an authorized Auditing Organization (AO), meets the quality management system (QMS) requirements of multiple regulatory agencies, derived from the International Organization for Standardization (ISO) 13485.

 

Employing a single audit program allows regulatory agencies to efficiently leverage resources, reduce regulatory burden on industry without compromising public health, and promote more aligned and consistent technical requirements, among other benefits. In addition to Health Canada, the participating Health Care agencies of the following countries are also committed to the MDSAP Program: Australia, Brazil, Japan, and the United States.

 

In accordance with Health Canada’s announced MDSAP Transition Plan, effective January 1, 2019 all manufacturers must comply to these new requirements.

 

CHS STATUS

CHS is proud to announce that we have successfully obtained our MDSAP certificate, this will allow us to continue to manufacture and supply our MED-RX Branded products in Canada. Please find our ISO 13485:2016 Certificate below.

 http://www.chsltd.com/DATA/TEXTE/40~v~iso-certificates.jpg

 

CHS 3RD PARTY PARTNERS

Due to these new regulations in Canada, a small number of our partners have decided not to move forward with obtaining the MDSAP Certifications and as such, their class II and higher product lines will no longer be available for sale in Canada.

 

These manufacturers include the following:

 

  • Havels (Hakko)
  • MedEvolution
  • Mermaid Medical
  • Couer Medical
  • Rex Medical
  • Tarry Medical
  • Millar
  • Thomas Medical

 

If you currently purchase any products made by the above manufacturers, please contact your CHS Sales or Customer Service Representative to discuss substitution options. CHS will continue to update this site with any further supplier status changes. 


Do you like this story?


Back to news list