Notice: Intent to Reclassify Disinfectants and Sterilants for Use on Medical Devices

September 14, 2016
Our file number: 16-110356-261

The purpose of this notice is to communicate Health Canada’s intent to reclassify disinfectants and sterilants that are intended for use on a medical device, including disinfectants of contact lenses. These products, which are currently regulated as drugs under the Food and Drug Regulations, would be reclassified as medical devices and be subject to the requirements of the Medical Devices Regulations. This reclassification would better align the Canadian requirements for these products with those of other jurisdictions in which these products are classified as medical devices. The risk classifications for these products as medical devices would be determined by taking into account factors such as the device risk classifications determined at the international level.

Until this reclassification is fully implemented, disinfectants and sterilants intended for use on a medical device will continue to be subject to the requirements of the Food and Drug Regulations, and the associated guidance documents for disinfectants will continue to apply. With respect to the Good Manufacturing Practices requirements for Active Pharmaceutical Ingredients, Health Canada is implementing an interim approach to information required on the Drug Establishment Licence Application Form (FRM-0033). Effective immediately, importers can complete the FRM-0033, Foreign Building Information Table (Table A) for Active Pharmaceutical Ingredients (API) intended for use in those product formulations using the following instructions:

1. Column L - Indicate 'Exception' and include the standard that the API is manufactured against (e.g. 'Exception - ISO').
2. Columns M, N, O and P can be indicated as "Exception".
3. All other columns should be filled out as per regular Table A instructions.

Comments on this notice of intent may be directed to Policy_Bureau_Enquiries@hc-sc.gc.ca for a 30-day period starting September 14, 2016 until October 14, 2016. Following this comment period, Health Canada will issue a final notice and will provide information on the reclassification and transition of these products to the medical device regulatory framework.