Strategic planning to avoid the pitfalls of registration
Timely registration in the target markets is the critical success factor of every innovation in the Medical Device industry. Given the complex and diverse market-specific regulatory requirements, manufacturers are recommended to systematically plan and prepare registration and all associated processes from an early stage, in parallel with product design and development.
Obstacles in the regulatory system
As different markets have different regulatory requirements, the registration of Medical Devices has its pitfalls. Even experienced Regulatory Affairs Managers find it difficult to keep track. In the euphoria of product development research-focused teams in particular may easily get sidetracked from the regulatory necessities and then be in for one or two surprises at the end of the design and development process. To name just two examples: Would you have known that the inspection required by the Brazilian registration authority ANVISA involves waiting times of two to three years and therefore must be applied for correspondingly early? And, do you know the risk class of your device in the USA and how this impacts on your further market planning?
Precision landing in product launch
Ex-post compliance with different national requirements for products or quality management systems, and thus for processes and documentation, is very often only possible with significantly higher efforts and delays. Manufacturers who know and consider the applicable regulatory requirements and other framework conditions from an early stage will be able to plan the market launch of their devices and avoid costly reworking later on. A well-prepared regulatory strategy is the best protection against excessive times to market and budget overruns.
Kick-off for the best possible regulatory strategy
The experts at TÜV SÜD Product Service manage the registration of Medical Devices all over the world and are familiar with the applicable national requirements in various countries. TÜV SÜD's Medical Device professionals know the critical questions that they must ask to enable manufacturers to identify gaps in their planning. This makes it easier for manufacturers to complete timely strategic planning of the product launch and of all necessary resources and budgets together with any necessary alignment of the regulatory strategy. TÜV SÜD has developed a special checklist that helps to get the ball rolling for this process. TÜV SÜD's specialists further offer to discuss the answers to these questions and their consequences in one or more meetings.