Most companies require registration and approval from regulatory agencies in each country in which they plan to sell their product for the commercialization of your medical device. 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 their 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 support medical device companies with their registration objectives in the following markets:
Australia / Brazil/Costa Rica / Hong Kong / India/Japan/Malaysia/ Costa Rica/Hong Kong/India / Colombia/ South Africa/ South Korea/ Egypt / Israel/ Mexico / Saudi Arabia/ Singapore/ New Zealand / Peru/ Russia/ Saudi Arabia/ Singapore/ Taiwan