Medical Device Product Registration and Approval
MEDICAL DEVICE REGISTRATION AND APPROVAL IN CANADA
Medical devices are classified into 4 categories namely class I, II, III and IV (I being the lowest risk and IV being the highest risk).
•Class I device does not require a registration license; and
•Classs II, III, IV, the product registration requirements are as per written in the Canadian Medical Device Regulation (CMDR).
The CMDR is also mentioned in specific the Quality Management System (QMS) requirements for the manufacturer. Currently, the manufacturer is required to comply with the quality management system known as CAN/CSA ISO13485 from the recognized registrar under the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS). This quality system will be replaced by MDSAP quality management system requirements by 1 Jan 2019.
ARQon can assist with product registration in Canada and setting-up of the quality management system so as to meet CAN/CSA ISO13485 or the MDSAP.
In terms of the Establishment License for the company, there are requirements for the Manufacturer, Importer and Distributor.
This Establishment concept has also been referenced to the development of Establishment Licensing requirements in Asia including Singapore. ARQon director has also helped in drafting of the Singapore regulation.
LATIN AMERICA REP
Foreign manufacturers must appoint an US agent as a local point of contact with US FDA.
If you are a foreign manufacturer, you may appoint ARQon to act as your authorized representative in the US.
Some of the responsibilities include:
Acting as a first point of contact with Regulatory authorities and import/customs offices
Being responsible for pre-certification and post-approval inquiries
Liaising between the Medical Device authority and foreign manufacturer in incident of Field Safety Corrective Action (FSCA), serious adverse event reporting to competent authorities, and in cooperation with manufacturer’s distributor