Guidance Document: Registration of a Test Kit for Medical, Laboratory, Industrial, Educational or Research Purposes

3. Scope

This document is meant to provide guidance to manufacturers applying to the Minister for a Test Kit registration number.

This is a guidance document only. It is meant to clarify the broad terminology found in the CDSA and its Regulations and to explain the application process to obtain a Test Kit registration number.

4. Definitions

Clarification is being provided in this section for some of the terms used in this document. Definitions in the Act and its Regulations supersede any given in these Guidelines.

a "Test Kit" is a kit

• that contains a controlled substance;
• that contains a reagent or buffering agent, or both;
• that is used in the course of a chemical or analytical procedure for medical, laboratory, industrial, educational, or research purposes; and
• the contents of which are not intended or likely to be consumed by or administered to, a human or an animal.

a "Controlled Substance" is any substance included in Schedule I, II, III or IV of the CDSA

"To sell" includes any of the following activities, whether or not the distribution is made for considerations:

• offering for sale;
• exposing for sale; or
• having in possession for sale and/or distribution.

5. General Application Information

Who may apply for a Test Kit Number:

• a manufacturer who makes or assembles a Test Kit.