Too often medical device manufacturers overlook the complexities of changing product names or ownership which requires regulatory re-registration and labeling changes. Consider these common scenarios: an acquisition or carve-out occurs, and the medical device has a new manufacturer. Or the manufacturer decides toward changing product names as a result of restructuring.

Both are common occurrences in today’s rapidly changing business environment. As a result, it’s up to medical device technology executives to execute the implementation plan. 

 

Product Name Change

However, moving the business forward often comes with reduced time or new priorities over resources. A manufacturer change or product name change requires modifications to the product labeling and regulatory re-registrations, which are increasingly complex. This article covers key steps required for successful re-registration and labeling changes while avoiding common pitfalls.

Requirements of Name Change

Most developed countries require a device to be registered, clearly displaying the legal manufacturer’s name. Abroad, outside the European Union (EU) and US about 40 percent of countries require a CE (European Conformity) certificate to register the product.

Roughly 20 percent of these countries require a certificate to foreign government (CFG) or certificate of free sale from the country of manufacture in order to register the product.

21 CFR 807

In the event of a company name change in the USA, the FDA requires an update to the registration per 21 CFR 807.26 and 21 CFR 807.30. In the event of a name change for devices sold in the European Union an updated CE certificate is required.

All countries that have marketing regulations for medical devices require notification in the event of a company name change. As a result, this can range from a simple notification to a full re-registration.

Product Labeling

A changed company name also triggers the need to update the product labeling. In the USA, the FDA requires registration within 30 days of commercial distribution of the device per 21 CFR 807. FDA 21 CFR 801 requires that the name of the manufacturer be conspicuously displayed on the product labeling. For product sold in the EU, the label must bear the name or trade name and address of the manufacturer per MDD 93/42/EEC Annex 1, 13.3. This requirement is the same for all countries that have regulations concerning medical devices.

Label Designer

Product labeling is a broad category when changing product names. The label designer or label design team may cover areas like the actual product label, instructions for use, product inserts, packaging and collateral such as brochures, catalogs and other promotional vehicles. The FDA does not require updated labeling to be submitted in order to change the company name, but clearly expects that the company will be making a good faith effort to update the label copy in a timely manner.

 

Requirements Beyond the USA Borders

For products sold to international markets, the requirements for each country must be researched and understood. In order to export the product, correct labeling and FDA registration is needed to obtain Certificates to Foreign Government (CFG).

Manufacturer Information

While no blanket rules that apply to requirements for all export countries, all countries do require the label to match what is listed in the registration, for example, in the EU the manufacturer information on the label must match the manufacturer information listed on the CE certificate and the Declaration of Conformity.

Implementation Plan

Outside of the EU, it’s not uncommon for CE and ISO certificates to be required as supporting documentation for registration. Each country has its own requirements for changing product names, so it’s necessary to develop an individualized approach to gathering requirements and developing an implementation plan (see table 1).

 

 

Risks and Pitfalls: Revenue Delays

During the merger or acquisition process, the deal makers might not fully appreciate the re-registration workload or timeframe. This task typically falls upon technical executives after the deal is signed. All too often, the acquiring firm has limited technical staff and a narrow bandwidth to take on such extensive research let alone the implementation in every country, and this oftentimes results in revenue delays. The technical executives have to bring the message about revenue delays to the management team who made the deal expecting they were buying an established revenue stream from the legacy product.

Product Re-Registration

One remedy for delayed revenues is to outsource the product re-registration process. Compliance consultants typically know the county-by-country requirements, which can help to eliminate the delays (see sidebar “Potential Revenue Delays in Canada and Brazil” below). Ideally the compliance consultants would be brought into the acquisition process during the due diligence stage.

Technical Data

Further, compliance consultants can help the acquiring firm anticipate revenue delays, quantify the re-registration costs, and identify any gaps in testing or technical data, which can be factored into the deal price and / or the post-transition agreements. For example, the post-deal transition agreement might require the seller to continue manufacturing the product until the buyer can re-register the product.

 

Cross Functional Re-registrations

The reasons that drive product re-registrations are oftentimes fraught with cross functional complexity. So while the technical team is re-registering the product and introducing new labeling into manufacturing plants, they’re also responsible for acquisition tasks.

Inventory Management

The product re-registration process could also include transferring production, which will trigger re-registration in most countries. Managing inventory across multiple countries and coordinating product with multiple distributors should be holistically reexamined. All this takes place while the technical executives remain focused on their primary job such as selling product to the marketplace.

 

 

Manufacturing Transfer

Oftentimes the manufacturing location changes as part of the merger or acquisition. Acquiring firms may see value in aggregating plants or in transferring production. The resulting changes in manufacturing location must be included in the registration process.

Manufacturing Process

The added registration complexities of changing location fall upon the shoulders of technical executives. Their strategic outlook includes shutting down the old facilities while onboarding new facilities. In addition, they have the challenge of introducing new labeling into the manufacturing process. As a result, a change in location can be a trigger for new facility inspections in many countries.

Distribution Challenges

Introduction of new product, and obsolescence of the old product requires coordination across manufacturing and distribution sites for each country. For countries with a long re-registration process, this means old product needs to be reserved. Countries such as Spain will allow a mixture of old / new product to be imported but will fine the company for exporting old product.

Import Export

For some manufacturers with multiple distributors in each export country, the coordination is very complex. Technical personnel already engaged in other aspects of the merger or acquisition will look to be more involved in the supply chain assessment. Some countries will also allow for a transfer of registration between distributors with a short approval time. However, other countries require a new or re-registration when a distributor is changed.

Labeling Revisions

A clearly laid-out plan that coordinates the registration with the labeling revision process. The strategy must include any potential manufacturing site changes to ensure continued market access and channel inventory for the product. The plan provides visibility for introducing the newly labeled product into the various USA and export markets.

 

 

Conclusion

Changes to the company name require modifications to the labeling and re-registration of the product. It requires a well-researched project plan that addresses the requirements of each country and coordinates cross-functional activities. Given the complexity of implementing the plan, experts recommend that companies forecast the name change costs and potential revenue delays.

Regulatory Due Diligence

It’s important that technical executives are part of the regulatory due diligence team during a merger or acquisition. Any costs and revenue delays should be factored into the deal price. When technical executives are stretched between conducting business and handling the re-registration, expert consultants can help quantify costs and delays. Having additional expertise on your team is a solid foundation to implementing the plan after the deal closes. All countries that have regulations concerning marketing of medical devices require some sort of notification in the event of a company name change.

 

About RCA’s Medical Device Consulting Services

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Cybersecurity

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

• SaMD Consulting
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Regulatory affairs is Regulatory Compliance Associates^® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

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Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates^® can help.

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Quality Assurance

Regulatory Compliance Associates^® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates^® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates^®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates^® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

• ISO13485 
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Regulatory Compliance Associates^® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance Associates^® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

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Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates^®  a competitive differentiator in the remediation space.

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Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates^® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates^® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

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About Regulatory Compliance Associates

Regulatory Compliance Associates^® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

• Life Sciences
• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

• Founded in 2000
• Headquartered in Wisconsin (USA)
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health^®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics^®, Nordion^® and Nelson Labs^®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

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Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

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