Post-Market Services

Track and validate incidents and complaints

Regulatory assessments and license renewals are the key requirements for sustained device availability and access. Failure to comply could result in corrective actions and/or recalls which could be followed by license suspension or cancellation. Manufacturers of Class II, III and IV devices that have received the Medical Devices License (MDL) are mandated to provide reports annually, either directly or through regulatory correspondents. To complement this, the Quality Management System (QMS) is renewed every 4 years.

A Medical Device License Amendment (MDLA) is required if the device undergoes significant change that may or may not affect the class of the device, and other changes including the device name, identifier and intended use. This could be accompanied by clinical studies, investigation, and test data and a modified QMS certificate.

As a regulatory correspondent, SigmaCan will represent your company to ensure timely submissions and follow up on pending applications, amendments, reporting and QMS updates. Supplementing this, SigmaCan will track and validate incidents and complaints directly in the respective provinces (state) with distributors, vendors and end users.  Further, all incidents and complaints will be logged and reported to your product/compliance team for action as required.

Scroll to Top