International Premarket Approvals

We are committed and take pride in the service we provide. Our office is based near Toronto, Ontario, Canada. Our service has gone beyond the borders of Canada and has expanded through North America, Asia, and Europe.

Medical Devices and Biosciences Regulation Compliance

The approval process has led to helping companies with establishment licenses, investigational testing, sterilization, premarket approvals, quality system CMDCAS, FDA GMP, 510K, medical devices regulations interpretations and compliance.

Trade Complaints - Medical Devices

On behalf of the manufacturer, importer, and distributor we will collect, submit and file in strict confidence your Trade Complaint. A trade complaint is one in which the complainant is often a company and typically relates to the activities of a competitor. The complaint typically relates to the perceived effectiveness or safety of a product. An alleged violation of the Food and Drugs Act, and related Regulations, are investigated. It may include contacting international agencies around the world. Enforcement is subject to the policies, procedures and to the Access to Information Act and the Privacy Act. In the event, that the complaint did not receive appropriate consideration a redress mechanism will be initiated with the appropriate Operational Centres.

Medical Devices and Biosciences Approvals

We advise companies so their business can grow. Our fees are reasonable and fair. We understand how critical it is to get your product to the market in a timely manner. Therefore, we ensure that all information required for device license submissions is accurate and supported to prevent time to market delays. As the old saying says “Time is money”.

Act as your Company Agent – Keeping Company Records Up to Date

Medical devices companies place their trust in our Regulatory Affairs Consultants to work with them and act as an agent on their behalf when dealing with the various government agencies. We can also act as your local agent to ensure that you are always kept up to date with regulatory changes and your technical files and other records are maintained.   

Training and Procedures (SOP)

We can help with FDA 510 K and Good Manufacturing Practices (GMP), ISO 13485 quality systems (CMDCAS), and CE Marking. Our consultants have a diverse business experience to develop audit plans, implementations, training and more.

Medical Devices Partnerships – Set up Distributors

We will work with companies to set up distributors and offer medical devices companies, a regulatory affairs partnership to enter North America’s market. As a regulatory affairs agency based in North America, some regulatory issues may require a personal visit with government regulatory agencies.

International Trade Business Opportunities – Medical Devices Companies

We collaborate with multi disciplines, professionals, government agencies, testing labs, associations and others related to planning regulatory strategies for medical device companies. We work hard to get the job done. We strive on results and our proactive mind set will minimize lost business opportunities caused by regulatory issues. 

Health Canada and FDA Compliance - MDALL

Health Canada and FDA are North America’s medical devices regulatory authorities. These agencies regulate the sale of medical devices in North America. You may refer to the Health Canada’s Medical Device Active License Listing (MDALL) and FDA’s 510K listing of devices on their databases to determine whether a predicated device is already on the market. We specialize in helping medical device companies comply with the medical devices regulations so they can gain access to North America’s market. Our hands-on experience in dealing with Health Canada and FDA provides efficient handling of regulatory affairs.

Regulatory Affairs Consulting

We provide Regulatory Affairs Consulting services for the development of international business and regulatory strategies to North America and foreign companies who plan to enter international markets in North America, Asia, Europe, and others. We can also help you with the preparation of ISO 13485 (CMDCAS) and GMP quality systems for the start up of a new manufacturing facility.

Establishment Licensing (MDEL) - Selling and Advertising Medical Devices

If you are an importer or distributor of medical devices and would like to sell, advertise, or distribute a device you will have to prepare and submit a Medical Device Establishment License (MDEL)

Our Regulatory Affairs Consultants will complete and file the MDEL with Health Canada and the FDA on your behalf so that you may begin exporting to North America’s market.

There is an annual fee for Medical Devices Establishment Licenses. Medical Devices & Biosciences International can provide you with an annual maintenance program to ensure that you are always in compliance with the regulations and your records are up to date.