Wellspect™ and compliance with Medical Device Legislations

As legal manufacturer and distributor of medical device products Wellspect HealthCare is obliged to ensure compliance to national, regional and international laws, guidance as well as international standards. 

As legal manufacturer of Medical Devices, we are certified by our Notified Body to:

  • ISO & EN ISO 13485:2016 – Quality Management System for Medical Devices
  • MDR 2017/745 – European Medical Device Regulation
  • MDD 93/42/EEC – European Medical Device Directive

This means we have a full Quality Management System and are also enabled to CE mark our products in compliance with the European Medical Device Regulation and Directive.

Although compliance to European regulation and directive plays an important role also for many countries outside Europe, we also comply with national laws in many other countries where our medical devices are registered, example:

  • FDA 21 CFR 820 Quality System Regulation (USA)
  • CMDR (Canadian Medical Device Regulations) SOR/98-282, P.C. 1998-783 May 7, 1998 and its amendments.
  • TGR:2002, Therapeutic Goods (Medical Devices) Regulations 2002 (Australia)
  • Good Manufacture Practices established by ANVISA, Guidance Resolution – RDC No. 16 of March 28, 2013 (Brazil) including resolution RDC 183/2017
  • Korean Medical Device Act (South Korea), Act No. 14330, December 2, 2016
  • NMPA National Medical Products Administration - China


External Quality Assurance and Certificates

Wellspect HealthCare is regularly audited and certified by Notified Bodies, who are reviewing our production facilities, Quality Management System and technical documentation, when needed, to ensure compliance to external laws, regulations and international standards.

Wellspect HealthCare is also certified by Notified Body for our Environmental Management System and ISO 14001:2015 - Environmental management systems - Requirements with guidance for use

Notified Bodies are independent organizations that have received a mandate by national authorities, to perform audits according to their competence area.  As evidence for compliance, different certificates are issued by Notified Bodies to Wellspect HealthCare.

The certificates may have different period of validity, depending on their scope, but common for all is that regular surveillance audits are performed during the validity period to reassure the auditors we are still in compliance with our Quality Management System and Technical Documentation.