Advice for a Successful Medical Device Global Registration Plan

One of the most powerful communication tools available to those responsible for placing medical devices on the market is a global registration plan. Such a plan outlines the regulatory requirements, resources, and related interdependencies to help coordinate and complete global medical device registration effectively and efficiently. Not only will a good plan turn the uncertain into the anticipated thereby reducing risk from a multinational product launch, but it can also help shape what may be a high-potential design concept and general submission strategy into a well-defined product with a schedule of tangible action items. The advice in this column is offered to support a successful global registration plan.

Start at the Beginning but Keep the End in Sight
There are two main questions that must be answered to drive development of a useful global registration plan. The first question is: What is the device?

In some cases, device definition may be well-understood and highly documented for a manufacturer, and fall within state of the art. In many others, especially for smaller manufacturers operating with a fair amount of flexibility, a medical device often remains a concept until it advances far enough in the product lifecycle that significant resource expenditure is on the horizon. The question at that point is: What exactly will the manufacturer be providing? Notably, the definition of a medical device varies across different markets and will be reflected in labeling.

Before or as part of a successful registration plan, a device’s defining features must be fully determined and documented. The device concept takes shape such that it can be identified with a name, a parts list, an intended use and indications for use, a duration of use, associated risks and benefits, and images/drawings. The device may also be provided in different configurations or for use with accessories or other products. It may be used by everyone or limited to a niche population. The device may be single-use or reusable. Without this foundational data set, a team will likely encounter confusion on related requirements, disagreement on the tasks at hand, possible duplication or completion of unnecessary work, and a seemingly endless rehash of prior meetings.

In parallel with device definition, the second key question is: Where should it be sold?

Although much effort has gone into global harmonization of medical device regulatory requirements, there are many opportunities for further harmonization. The more definitive the list of countries and markets that should be considered for product launch, the better the chances for leveraging overlapping requirements, optimizing resource use, and minimizing the risk of costly missteps.

Prioritization of markets based on sales forecast, regulatory pathway and ease of entry, and potential use by key thought leaders could further optimization by aligning the most important and urgent needs with available resources. Such refinement of the objective(s) with supporting data may be used to create a more compelling argument to procure supplemental resources and funding, if needed. In addition, understanding the distribution plan and sales model in each market can be used to add nuanced detail to a plan that others may have overlooked.

Delve Into Details but Keep it Simple
Once the device is well-defined and the countries and markets for sale are identified, detailed information and interdependencies can be determined and added. For each market, consider the following information categories and document what is needed and/or how each consideration will be addressed:

• Applicable regulations, recognized standards, and guidance documents
• Device classification, codes, and other administrative information
• Deviations to the product definition, due to market-specific needs
• Applicable submission type and justification, including potential effects on reimbursement
• Content requirements of the submission, including clinical and non-clinical aspects
• Submission timelines and dependencies
• Submission costs including fees and use of external resources (e.g., document legalization, translations, consultants)
• Other referenced or included device registration information (e.g., for accessories or compatible devices)
• Product labeling considerations (e.g., symbols, instructions for use, translations, UDI) and requirements associated with any marketing claims
• External database considerations
• Quality management system requirements and related updates
• Expected registration output (e.g., certificate, scope of coverage)
• Renewal requirements (e.g., duration of certificate validity, recurring fees)
• Related roles and responsibilities (e.g., manufacturer, importer, authorized representatives, marketing authorization holders)
• Anticipated resource use (e.g., in-house vs. external)

In addition, identify the documentation or activities that may be leveraged between markets. It may become apparent that some registration activities can be grouped or tiered naturally based on shared action items. Also consider this in relation to the prioritization of the global launch list, as it could be beneficial to revise its prioritization.

Details are important and they will be referenced during the plan’s execution; however, keeping contributors, reviewers, and approvers on task is equally important. For this reason, include an executive summary of the plan that touches on the most meaningful information to the audience and cites supporting detail. Keep contributors, reviewers, and approvers clear on the parts of the plan for which they are responsible. Use plain language, minimize redundancy, get to the point, keep it clean, avoid jargon and idioms that cross-functional and cross-cultural audiences may not appreciate, and exclude unnecessary text and figures.

Work With a Team and Be Open to Change
In many cases, it is unlikely that any one person is knowledgeable enough to complete a full global registration plan on their own, given the level of expertise needed for individual markets and all the cross-functional considerations previously listed. Take advantage of in-house experts who have experience with different markets or are eager to learn about a new one. Engage distributors or third parties who will help execute the plan and benefit from having another product in their portfolio. Seek help from subject matter experts where needed to complement available strengths and fill in any gaps.

A project manager can be a strong ally to getting what is needed to create and execute a plan. They can also help with basic project management tools and advice such as creation of a responsibility matrix (e.g., RACI matrix) or Gantt chart, depending on the global registration plan’s complexity. Team members may also use global registration plan information as inputs to their assignments, considering the overlap with design control, risk management, reimbursement, clinical study, and post-market requirements.

Having a solid plan at the outset will help keep everyone moving in concert toward an on-time and on-target delivery; however, medical device global registration plans are seldom executed exactly as originally written. A revision-controlled plan that can be updated to address both anticipated risks and unforeseen issues will help keep the team on track and illustrate the effects these changes have on the overall project. Reasons to adapt a plan include but are not limited to: unexpected test results, addition of a new distributor, project scope changes, new guidance documents, and audit results.

Also consider requiring different information for the plan at different product lifecycle stages. Revision control allows information to be added when it becomes available but also before it is needed, providing the project team with more flexibility to what is often an iterative information-gathering process.

A registration plan is only as good as the accuracy of its information, and it can become outdated. If a significant amount of time passes between agreement on the plan and execution of some activities, consider revisiting the plan to ensure changes can be addressed and are clearly communicated with team members.

Build a Foundation for the Future
While the details of each plan will vary based on answers to the two previously stated main questions, the overall structure and approach as well as much of the content can be reused. The collection of plans not only helps build a repository of country- and market-specific information that may apply to future pre-market devices, it can also elicit unique best-practices that could feed into a template or controlled procedure.

In addition, the plan will be helpful in post-market phases. For example, the documented registration history may be invaluable to a new hire tackling a change assessment for a device they are working with for the first time, or perhaps a prior plan may be used to help executives decide whether to renew a device registration.

Be Gracious and Show Gratitude
As with other collaborative endeavors, remember the effort it takes to build and maintain a plan. While a single person may have compiled the information and authored the plan, others likely provided their experience and opinion, their vision and realizations, their lessons learned and constructive criticisms, and perhaps even praise. Some team members may have worked odd hours in other time zones, on short notice, or on topics outside of their comfort zone. Acceptance of change is also easier for some than others. Ensure people know their contributions are needed and appreciated, and even skeptics may come to enjoy the creation, discussion, and execution of a medical device global registration plan. 

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Kara Budor is senior manager, International Regulatory Affairs, for MCRA and specializes in international regulatory strategy, writing regulatory submissions, developing and maintaining technical and regulatory documentation including clinical evaluation reports, and performing gap analyses. Prior to joining MCRA, Budor worked in regulatory affairs and product development departments for an orthopedic device manufacturer. She earned M.S. and B.S.E. degrees in biomedical engineering from the University of California – Davis and the University of Iowa, respectively.