Natural Health Products and Medical Devices

The Drug and Drug database were discussed previously. Now We look into Natural Health Products in Canada and find out why and how does Health Canada regulate NHPs. We also take an overview of Medical Devices in Canada.

Natural Health Products
Regulating vitamins and minerals as natural health products brings several advantages to Canadian consumers. The mandatory pre-market review of all natural health products ensures that what is on the label is what is in the bottle, and that health claims are supported by appropriate levels of evidence. Unlike foods, which are limited under the Food and Drug Regulations to diet-related or nutritional content claims, natural health products can make the full range of health claims that consumers and industry have requested, including risk reduction, structure-function and treatment-prevention claims, where sufficient evidence exists. At the same time, the Regulations increase the safety and efficacy of natural health products by requiring clear labelling information, for example on treatment, dosage and health warnings, as well as pre-market review and assessment, which is not generally required for foods. With this framework in place, Health Canada is helping Canadians have access to natural health products that are safe, effective, and of the highest quality.
The Natural Health Products Regulations (the Regulations) came into force on January 1, 2004, and apply to all natural health products (NHPs) as of this date. The Regulations define what NHPs are and set out the requirements for their sale, manufacture, packaging, labelling, importation, distribution, and storage. This document explains Health Canada's compliance policy with respect to these products. Persons manufacturing, packaging, labelling or importing a NHP before this date, have a transition period two years to comply with the site licence requirements of the Regulations. NHPs with a valid Drug Identification Number (DIN) have six years to obtain a product licence under the Regulations.
This policy explains the compliance approach with respect to NHPs which have not received market authorization by way of a Drug Identification Number (DIN) or an NHP product licence designated on a product label by an NPN number or a Homeopathic Medicine Number (DIN-HM). Any NHPs that have been issued market authorization but otherwise are non-compliant with the Regulations are not within the scope of this policy and will be subject to appropriate actions. The policy does not apply to foods, drugs, and cosmetics, regulated under the Food and Drug Regulations, or veterinary drugs.

Medical Devices Active Licence Listing (MDALL)
MDALL contains product-specific information on all medical devices that are currently licensed for sale in Canada, or have been licensed in the past. This system has been designed to help health care workers, who are contemplating the purchase of a Class II, III or IV medical device, to verify that the manufacturer has an active medical device licence. Since medical device licences can be suspended by Health Canada, cancelled during the annual renewal of licences by Health Canada, or discontinued by the manufacturer, it is important to conduct this verification each time the purchase of a medical device is considered.
To search medical devices used in Canada go to http://205.193.93.51/mdall/