Driven by social, economic, and environmental factors, our world is changing at an unprecedented rate – and so are medical devices. From switches to swipes, hardware to apps, and hospitals to the home environment, healthcare continues to experience a paradigm shift. This complexity and speed of change is challenging medical device manufacturers to not only keep up with innovation, but ensure their new products are safe for use by both professionals and inexperienced home users.
Competing in an evolving and interconnected global market also requires a solid understanding of the various technical and regulatory requirements for medical devices. But many companies in the industry only have experience with single-country access. As requirements vary from country to country, companies may struggle at the beginning of product development as they try to navigate the requirements for multiple target markets, especially if they lack the resources to do this internally.
In this constantly changing environment of safety, conformity, and market access requirements, it is crucial to not only respond to the regulatory needs of today, but anticipate those of tomorrow.
This article offers a step-by-step guide to keep you on track in your quest to obtain global product approvals.
1) Identify and Engage Key Stakeholders
To access global markets and avoid costly delays to product launches, make sure to identify and engage your key stakeholders early on in your market access strategy. These include:
- Design engineers, who need to know the applicable standards to design compliant products;
- Testing or compliance engineers, who have experience working with a testing & certification agency to help ensure compliance; and
- Regulatory compliance team members, who can prepare product manual/label/quality management systems to help ensure full product compliance to regulations.
Other relevant stakeholders may include Research & Development (R&D) personnel, risk management staff, and marketing. A global testing & certification body can connect you with the right industry players to get your product to market faster.
2) Consider Geographical Differences
Product approval processes vary across North America, Europe, and Asia as they must adhere to national or regional regulations set by governing agencies, such as Health Canada and the U.S. Food and Drug Administration. More and more countries are adopting global standards set by organizations such as the International Organization for Standards (ISO) or the International Electrotechnical Commission (IEC), but companies need to keep in mind that national and regional variations exist. These include harmonized standards that apply to the European Union.
Though technical standards vary around the world, there are many countries that follow a different version of the same standard, which can further complicate the process.
These differences may require product adaptation for the company to receive safety approval and sell their product to those markets. A good example is the manner in which nominal voltage frequencies may affect product design for foreign countries.
3) Seek an Experienced Third-Party Testing & Certification Agency
A recognized third-party testing & certification agency can save you valuable time between product idea and launch – time that can be the difference between customers buying your product or your competitor’s. The laboratory must, however, be ILAC- accredited under ISO 17025 to issue test reports that you can use to sell your product in countries participating in the ILAC scheme.
Other advantages of working with a global third-party testing agency include:
- Thorough and up-to-date knowledge of national and international regulations for various industries;
- A localized, single point-of-contact for streamlined and effective project management;
- Seamless integration with your product development cycle;
- More predictable time to market; and
- Multilingual service capability.
To help ensure your projects are delivered within your timelines, look for a testing & certification agency that:
Standards development expertise is critical to anticipating updates to requirements that affect product design.
4) Don’t Fall for These Misconceptions. Do it Right.
One report can be accepted by all countries and one registration can be used by other countries.
Reality: You can leverage a certificate to access other markets, but cannot transfer it directly.
It is overly complicated to access multiple markets.
Reality: Many people do not realize that the IEC 60601-1 standard for medical devices is widely accepted with limited national deviations.
Do it Right: Accessing multiple markets doesn’t need to be overly complicated, but you need to follow the proper process. Work with an ILAC-accredited third-party testing & certification agency so that you can launch your product in the global market more easily. For faster market access, engage your stakeholders and third-party provider early in product design so that you receive the approvals you need to move forward.
CSA Group can help medical device manufacturers navigate global regulations and help ensure product approvals for timely market access. Find out more.