As a highly valued regulatory resource to the industry, manufacturers, distributors and importers consistently rely on the quality and timeliness of our regulatory work.
- Regulatory strategic planning
- Organize and manage TPD meetings
- Prepare and file CTA’s (Clinical Trial Applications)
- Prepare and file Class II, III and IV applications
- Application support during TPD review
- Quality System audits (QS – GMP – ISO – CMDCAS)
- Label and advertising review
- Regulatory compliance issues
FAQ – Canadian Medical Device Conformity Assessment System or CMDCAS:
1. What is the main purpose of the CMDCAS?
The main purpose of CMDCAS is to provide documentation from a third party registrar, that medical device companies are actually complying with the quality systems requirements of sections 32(2) (f), 32(3) (j), or 32(4) (p) of the Medical Device Regulations.
2. Where does CMDCAS fit within the licencing process of medical devices in Canada?
As of January 1st, 2003, medical device companies submitting an application for a Class II, III or IV medical device must also submit a copy of a valid CAN/CSA-ISO 13485-98 or CAN/CSA-ISO 13488-98 quality system certificate issued by a CMDCAS recognized Registrar. The certificate will inform TPD that there has been an impartial assessment of the manufacturer’s quality system, and found it to be in compliance with the quality system requirements of the Medical Devices Regulations.
Do medical devices already licenced in Canada have to have a CAN/CSA-ISO 13485-98 or CAN/CSA-ISO 13488-98 certificate?
Yes, the Medical Device’s Regulations’ quality system requirements apply to all Class II, III, and IV medical devices.
Who has to get the CAN/CSA-ISO 13485 or CAN/CSA-ISO 13488 certificate, the manufacturer, the distributor, or simply the company whose name appears on the label?
The responsibility of securing the certificate lies with the company whose name appears on the device. For more information regarding the CMDCAS and it’s implementation date, please feel free to give us a call at 905.836.0033, or email mccarthy@mccarthyconsultant.com
