Experts in the Canadian Regulatory Environment
Aesthetics Biomedical realizes that worldwide market access provides the best opportunity to earn the market share you deserve.
USFDA, EU CE Marking and Health Canada market access gives both credibility and the best chance of success. This is why Aesthetics Biomedical always targets these three key regulatory applications at the same time.
In July 1998 Canada introduced new regulations governing the importation, sale, and advertising of medical devices. These new regulations were modelled after European the regulatory process. The key processes in the Canadian requirements include:
- Classification rules for medical devices and for in vitro medical devices
- Safety and effectiveness principles that apply to all medical devices
- Quality management system requirements based on CAN CSA ISO 13485
- Canadian unique labelling requirements
- Medical Device Licensing
- Establishment Registration
The risk classifications, like Europe begin with low risk devices designated Class I. These devices have little regulatory scrutiny right through to the highest risk devices in Class IV with considerable regulatory scrutiny. Market access clearance in Canada is through a medical device “license” which is required for Risk Class II through IV classification. However no license is required for Class I.
The principle issue confounding medical device license applications is the Canadian Medical Device Conformity Assessment System (CMDCAS) which requires an applicant to have their manufacturing operations registered by a CMDCAS accredited registrar to the requirements of CAN CSA ISO 13485. Class I manufacturers are exempt from the quality system requirement however it is mandatory for manufacturers of Class II, III, and IV. Health Canada also has a host of recognized Standards and guidance documents. Aesthetics Biomedical is fully compliant with all Canadian medical device regulatory requirements.
There are fees associated with medical device license applications and/or an establishment registration fee. The safety and effectiveness principles (section 10–20 of the regulations) resemble the Essential Requirements for EU CE Marking. However they are both shorter and different.
Canadian requirement while similar have many unique differences that if not accommodated in R&D can greatly increase both costs and time to market. Aesthetics Biomedical is intimately familiar with Canadian requirements which make market access significantly easier.
Aesthetics Biomedical’s executive team and regulatory experts stay on top of requirements by participating in a host of national and international forums, standards writing efforts, advisory committees and by periodically meeting with regulatory agencies right around the world. We manage and implement change before it is mandatory to do so.
Aesthetics Biomedical is the “can-do” partner every company in this dynamic industry should have.
For more information on how Aesthetics Biomedical’s regulatory team can help you overcome barriers please send us a message or call us at 1.800.726.5029