AIM Manufactures Medical Devices in Canada for Foreign Corporations

Background:

Canadian Law requires a company who wishes to distribute medical devices in Canada to first have their products approved by the Government authorities at Health Canada. Approval usually hinges on having an ISO13485 approved manufacturing processes as accredited by an auditor that has CAMDICAS certification. All relevant documentation and paperwork must accompany the application and the process can take from 2 to 6 months to complete depending on the complexity of the application.

Once approved, importation and distribution in Canada requires that the distributor must also be licensed to import and distribute medical devices. This is a separate licensing designation.

Process:

AIM Instrumentation Ltd. is our technical corporation, and it specializes in Virtual Manufacturing. Products that qualify under our specifications are registered as Manufactured in Canada by AIM Instrumentation, and can then be sold on the Canadian Market. This process can take up to 6 months and costs vary depending on the nature of the application. Close cooperation is required between AIM and the contracting company and complete detailed documentation is required for each product. AIM must meet a stringent ISO 13485 audit to register new products that are to be manufactured in Canada.

Once registered, AIM will act as a distributor for the products, or the manufacturer can choose to designate their own distributor. A Manufacturing Agreement and A Commercial Agreement Contract between AIM and the applying foreign company will be negotiated and will cover details of ongoing business arrangements.

For more information Contact AIM Instrumentation Ltd.  at aimtechnologies.ca

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