Much like a business plan, a company’s regulatory strategy sets a plan in action to market medical device products in specific countries. The regulatory strategy details a description and intended use for each of the company’s products, identifies the countries where each of the products will be marketed, records the device classification decision, and develops an implementation plan.
The regulatory strategy is a living document that gets updated whenever there is a change to the company, its products, or regulatory compliance landscape. Depending on the size of the company, complexity or products, and marketed areas; the regulatory plan could be one simple document or many documents based on products and marketed regions.
Assign an individual to be responsible for establishing and maintaining your company’s regulatory strategies and make it top management’s and product development’s responsibility to contribute to and know the content in the regulatory strategies.