Monday, October 5, 2009

Class II Application - What's Required?

Section 32(2) of the Medical Devices Regulations outlines the requirements for a Class II License application.

An application for a Class II medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:

(a) a description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented;

(b) a list of the standards complied with in the manufacture of the device to satisfy the safety and effectiveness requirements;

(c) an attestation by a senior official of the manufacturer that the manufacturer has objective evidence to establish that the device meets the safety and effectiveness requirements;

(d) an attestation by a senior official of the manufacturer that the device label meets the applicable labelling requirements of these Regulations;

(e) in the case of a near patient in vitro diagnostic device, an attestation by a senior official of the manufacturer that investigational testing has been conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use; and

(f) a copy of the quality management system certificate certifying that the quality management system under which the device is manufactured satisfies National Standard of Canada CAN/CSA-ISO 13485:03, Medical devices — Quality management systems — Requirements for regulatory purposes.

1 comment:

  1. Hi.

    I read a same topic 2 month ago. The topic helps me to improve my competency.

    Apart from that, below article also is the same meaning

    ISO 13485 checklist

    Tks again and nice keep posting
    Rgs

    ReplyDelete