Medical Devices & Biosciences International (MDBIO) is a regulatory affairs consulting service. We work with medical device companies whose vision is to expand their market share by exporting and importing medical devices to and from international markets. We provide the regulatory compliance and consulting services for those medical device companies who have North America on their radar. Our Regulatory Affairs Consultant will prepare premarket applications in accordance to the Medical Devices Regulations. Medical device companies in Canada and abroad are very focused in getting their new and existing products on the market in a timely manner.

Canada Medical Devices Regulations

The handling of regulatory affairs for medical devices will be done in accordance to the Medical Devices Regulations related to Class I, II, III, and IV. We collaborate to develop regulatory and export strategies to get the medical device premarket application approved. When feasible, the Global Harmonization of the medical devices regulations will be considered.
          
Global Harmonization of Medical Devices Regulations

The Global Harmonization Task Force was founded in 1992 and the work done by Study Groups 1, 2, 3, 4 and 5 will certainly have an impact on the future of the medical devices regulations for premarket approvals. As a former Director of Regulatory Affairs for Medical Devices Canada (MEDEC) and participating member of the GHTF task force, Medical Devices & Biosciences International encourages the use of the GHTF guidance documents. The GHTF guidance documents may be referenced and used as a guide by medical device companies creating or changing procedures and want to harmonize regulatory protocols to facilitate international trade.

Medical Device Companies

The Canadian medical device companies are located in central, eastern, and western Canada. The companies represent medical devices for hospitals, cardiovascular, orthopedic, ophthalmic, diabetes, in-vitro diagnostics, reagents, and dental. Canada’s medical device export, and import market is increasing and is certainly to become a focus for Small Medium Enterprises (SME’s). Medical devices companies will need to establish marketing and regulatory strategies.  

The exporting and importing of medical devices is subject to North America’s Medical Devices Regulations. The challenges in this new international trade environment will be the ability to locate foreign partners, manage partnerships across cultural and linguistic boundaries, and at the same time ensure that medical device companies comply with the current Medical Devices Regulations and keep up with the most up to date ongoing regulatory changes. The Asian companies and entrepreneurs are creating social structures that enable the smallest producer to locate and maintain mutual beneficial collaborations for international trade efforts for medical devices across long distances.

Market Authorization Time - ROI

Medical Devices & Biosciences International brings many years of hands on experience with international Medical Devices Regulations in North America, Australia, Europe, and Asia. We assist North America companies to develop their market within the medical devices regulations and quality systems ISO13485 (CMDCAS) and Goods Manufacturing Practices (GMP). Furthermore, we can provide support with the formulation of export market entry, business development programs for North America and companies from other countries who plan to develop export or import opportunities. Market authorization time is constantly monitored through the review process in order to get a speedy return on investment (ROI).

Convergence of Medical Devices & Biosciences Technologies

Medical Devices & Biosciences Int’l (MDBIO) encourages convergence of the Global Harmonization Task Force guidance documents released by the GHTF Study Groups. Applying the appropriate regulations to new technologies or without predicated devices is always a challenge. I.e. software and hardware, diagnostics, new combination technologies.