Most companies require registration and approval from regulatory agencies in each country in which they plan to sell their products for the commercialization of their medical devices. The specifications of product registration vary considerably for every country, creating enforcement challenges for multiple market strategy companies.
Valid registration, depending on where you intend to sell your products, can entail a significant effort to meet premarket technical and clinical submission criteria. We help companies like yours to register products globally. Our consultants are responsible for registering devices and regulatory compliance on established markets, such as the United States, Europe, China, and emerging markets. E & E Medicals and Consulting support medical device companies with their registration objectives in the following markets:
Australia / Brazil / Colombia/ Costa Rica / Egypt / Hong Kong / India / Israel / Japan / Malaysia / Mexico / New Zealand / Peru / Russia/ Saudi Arabia / Singapore / South Africa/ South Korea / Taiwan