FDA Resources Canada

Your Guide to Canada

Here below we help you dive deep into the regulatory requirements of Myanmar and answer some of the basic questions.

Still confused with the complete process? - Genedrift assists you with all regulatory requirements as mentioned.

Guide to Drugs

What is the process for NHP Registration? and how long does it take?

The registration - from start to end !

In order to market your products in Canada, the Natural Health Products Regulations first require you to obtain the necessary product and site licenses.

Product Licensing: Before any (natural) health product can be sold in Canada, it must first be subjected to a pre-market review where an assessment on parameters including safety, efficacy, and quality will be done. There must be sufficient evidence demonstrating the parameters be submitted to Health Canada by means of a product license application (one for each product). Products, which meet the required criteria, will be authorized for sale and each issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). However, where a pre-approved monograph exists, the application is not required to establish these parameters.

Site Licensing: The NHP Regulations require a site where natural health products are manufactured, imported, labelled, packaged, distributed, and/or stored to have a site license. Businesses can choose to have a single site license for all their operations (i.e. multiple sites) or an individual license for each site. Site licenses are obtained by demonstrating that the above mentioned activities are conducted in a manner that is congruent with the requirements of the Canadian Good Manufacturing Practices (GMPs) for NHPs. Audits by Health Canada for NHPs are very limited.

Different Classes of NHP Applications

Document - Checklist

Health Canada has published various monographs. With the monographs as a reference point, the application streams can now be better defined as follows:

Class I: must comply with all of the parameters of an individual NNHPD monograph with no modifications. Only one NNHPD monograph per application in Class I can be referenced. Example - Povidone Iodine Ointment / Cream.

Class II: supported entirely by a combination of 2 or more NNHPD monographs or 1 NNHPD monograph, where slight deviations to claims are permissible.

Class III: a full assessment required as in the following cases: novel preparations, ingredient master files, ingredient combinations, and going beyond NNHPD monograph parameters

Guide to Cosmetics

Is there a regulation for Cosmetics?

Health Canada monitors production and distribution of Cosmetics. Prior to placing Cosmetic products on the Canadian market, they must comply with the Food and Drugs Act, with the Cosmetic Regulation as well as the Consumer Packaging and Labelling Act.

The Food and Drugs Act provides a definition of a cosmetic product in Canada.

Cosmetic products include “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes”. This includes cosmetics used by professional aesthetic services, bulk-bought institutional products (for example, hand soap in schools) and handmade cosmetics sold at craft sales or from home-based businesses.

The classification of the product can often depend on the claims made about its performance and function.

Requirements

The most important requirement is that cosmetic products sold in Canada are manufactured, prepared, preserved, packed and stored under Good Manufacturing Conditions sanitary conditions and are, therefore, safe for use by the consumers.

When used as intended, a cosmetic product must not pose a risk to consumers. The safety of the product must be determined but the legislation does not specifically prescribe how the safety of the product is proven and demonstrated; that is the responsibility of the product manufacturer.

Health Canada maintains quite an extensive list of ingredients that cosmetic products should not contain, can contain only up to a certain maximum concentration or can contain under certain conditions along with the warnings that have to be displayed about the use of such ingredients.

This list is referred to as the Cosmetic Ingredient Hotlist. However, this list contains only ingredients used intentionally, it does not include unintentional ingredients.

The product labeling must comply with specific requirements as per Food and Drugs Act, the Cosmetic Regulation, Consumer Packaging and Labelling Act and the Hazardous Product Act. Special attention must be given to the language used as at least some parts of the label also have to be written in French.

There is no pre-market registration for cosmetics that would lead to an official approval for sales in Canada but all cosmetic products placed on the Canadian market, whether manufactured in Canada or abroad, have to be notified to Health Canada using the Cosmetic Notification Form within 10 days of being placed on the market. Failure to do so may result in a product being denied entry into Canada or being removed from sale. The information that needs to be provided on the CNF includes, the product identity, the product function, labelling for certain types of products, a list of ingredients and their concentrations, the product category, etc.

Guide to Food, Medical Devices

Medical Devices - What is the licensing / registration process?

You require a license if you fall in any of the below -

Class I to IV Medical Devices

Required if you distribute or import class I to IV medical devices

Class I Medical Devices

Required if you manufacture Class I medical devices in Canada (eg. shields, masks, gowns, toothbrushes, etc.).

Foreign Businesses

Required if you manufacture, market or distribute medical devices to Canadian resellers from any other country (businesses outside Canada)

Audits are usually conducted by Health Canada conducts remote/virtual assessments of MDEL holders as soon as the MDEL is obtained

Classes and Timelines

Medical devices in Canada are classified as per Health Canada’s risk-based practice.

There are four device classifications, Class I, Class II, Class III and Class IV. Classification of medical devices dictates the type of license required for your product.

Class 1 medical devices (example - Thermometer) are excluded from requirement of having a medical device license. For Class 2, 3 and 4 medical devices, a license is mandatory before being allowed to sell devices of these classes in Canada. Class II, III, and IV devices require a product-specific Canadian Medical Device License (MDL).

Class 2 - have a 15 calendar day review time target.

Class 3 - have a 75 calendar day review time target.

Class 4 - have a 90 calendar day review time target.

How can Genedrift help?

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Pathway

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