Optimising international approvals

How can I optimise submissions for a MD that I want to market in different countries?

Challenges of a structured regulatory strategy

The goal, after having clearly defined the classification of your device by country, is to determine strategically the common requirements between the target countries. An action plan should be set up to identify the priorities for submitting files to the competent authorities. There is always a best route or routes to determine the order of submissions.

Establishment of a regulatory strategy is recommended as soon as the feasibility study phase. It allows you to optimise time to market, obtain a global regulatory vision to find out the best possible obstacles and roads, and reveal ambiguities between marketing countries.

nex’strategy allows you to:

  • Class your product by country, according to its demands and indications for use, and the regulations in the countries concerned;
  • List the regulations and standards applicable in your marketing country;
  • Develop a strategic plan to identify development and marketing priorities of your product depending on the target country;
  • List the different solutions to address methodically the common requirements between the target countries, and to meet the specific requirements by country;
  • Set a simplified strategic plan that will help you develop your technical files in an organised, relevant and logical manner in order to begin the submissions;
  • Establish technical documentation for the marketing country.

Benefits for your business

  • A simplified understanding of the regulation according to the marketing country;
  • An understanding of strategic issues in the submissions in order of priority;
  • Clarification of regulatory, technical, scientific constraints by country;
  • Controlled and structured organisation in the implementation of technical files by country;
  • Lack of ambiguity in the classification of the country;
  • Optimised and administrative logistics transposable to other projects.

What are the risks of an unstructured approach?

  • A potential error in the classification of the country;
  • Loss of time in the submission of applications for obtaining a product;
  • Financial loss due to poor optimisation of the design process technical files in different countries.

Our solution