Local representative and what you need to know

Several countries require an in-country representative. This company is often chosen by the marketing department to market and distribute the medical devices in the country. But is this really the best strategy when it also includes being the regulatory contact with the authorities?

The marketing department is without doubt the best department to choose sales representatives and distributors. However, they may not be the best to evaluate if a distributor has sufficient knowledge of the regulatory requirements. Since the country representative is your spokesperson towards the authorities concerning registration, product changes and vigilance in some cases, they need to have appropriate knowledge about these issues. Additionally, manufacturers often depend on this company for keeping them up to date with changes in the local regulations and sometimes require assistance to determine if a product change need notification. This is not something you want to get it wrong.

But to be fair, you also need to see the selection of the distributor from the view of the marketing department. What’s the point of a distributor who knows the regulations by heart but wouldn’t be able to sell life jackets on the sinking Titanic.

Another important aspect to consider when choosing an in-country representative is that if you are dissatisfied with a distributor and wish to change, it can be a cumbersome and expensive endeavour if the distributor also is the registration holder. It can end up in a scenario where you will have to buy the registration from them or start the registration process from the beginning with a new distributor.

So, as always; Plan before Do.

Determine exactly what the local representative must be responsible for and limit the contract to those areas. If possible, determine that you, the manufacturer shall be the registration holder. If this is not possible, my advice is to use an independent regulatory affairs contractor as your licence holder. This way you can appoint whomever and as many distributors as you want. Obviously, the distributors will still have some regulatory obligations, but these would be limited to things like traceability and complaint/vigilance procedures. Authority contacts and registration updates would be routed through the RA-contractor. The RA-contractor can also be very helpful if the local health authority would like to do an audit on your facility which is not uncommon.

Noteworthy, is also the fact that the distributors often provide a template for what the Letter of Authorization should look like. This is very convenient, but make sure that you really want to give them all the authority that is described in the template. Additionally, it is a good idea to set an end date of the contract or a clause on how the termination should be conducted. This is to avoid any trouble in the future. Depending on the complexity, it can be good to have a legal person to review the contract before signing.

There are a lot of things to consider before you enter the new market, but to quote Arthur Miller; “The jungle may be dark, but it´s full of diamonds.”

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Finally, summer vacation!

During the late spring, the time for summer and for vacation can feel far away. But one thing is certain, it will always arrive and finally, now is the time to wrap up the first 6 months with a few words.

The medical device industry has been home to some of the most revolutionary innovations of humankind. Innovations have been a cornerstone for the advances in global health and there is a never-ending increase indemand for new medical devices.

During the past years, there has been some major trends attributed to the transformation of the medical device industry. As consultants we see an increased need for support with regards to Artificial Intelligence (AI), Machine Learning (ML), health apps, journal handling systems, wearable fitness medical devices, cybersecurity and more. New products are booming in the market, that hardly even existed ten years ago. AI and ML are becoming more common and continue to enable healthcare providers to detect or predict diseases, as well as enhance more personalized care for the patients.

Advanced technologies and the complexity of the regulations place great challenges on all stakeholders within the medical device sector. Both the regulatory landscape and latest technologies are in constant motion. Regulations, directives guidelines, standards keep getting revised or updated and development of technologies is now moving really quick. Authorities and notified bodies need to establish long term strategies to ensure that they can meet the future need for certifications and surveillance.

For us as consultants, we see a fantastic possibility to contribute with our solution-oriented knowledge and at the same time learn new innovations from our clients. To further develop our own services, we completed our ISO 13485 certification in May this year. This is a great milestone for all three companies within QAdvis group, and we are now even better equipped to meet our client needs.

Now when the summer is finally here and the “to-do-list” seems long, it might be difficult to take the first step into vacation-mode. But start with clearing your desk, write a list with remaining tasks, activate autoreply and just step out to the much long awaited recovery time during this, hopefully, warm and sunny summer weeks!

Finally, and most importantly, the whole QAdvis team would like to thank all our clients, partners, and employees for a content-rich, exciting, and challenging spring. We wish you all a lovely summer and look forward to continued collaborations after the vacation.

If you have any questions, don’t hesitate to contact us at info@qadvis.com  or annelie.hagstrom@qadvis.com

 

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Gardening – Just like a medical device registration, it needs to be maintained!

Everyone who has a garden knows that the work in the garden is never done. Even if you have done your landscape planning according to the least burdensome approach, planted all the right plants and designed in perfect pathways, there will still come a day when your maintenance work starts. The situation is the same with medical device registrations.

Although you have submitted a product registration that just flew through the FDA or Japanese PMDA without questions, all your registrations need to be maintained. And it is important to remember at both the times, i.e., when you initiate a registration in a particular region as well as yearly when you plan the resources.

Firstly, you need to be aware of how often each market requires re-registration and how complex they are. It can be anything from just submitting your quality certificates all the way to onsite audits on your manufacturing sites. Also, the length of the re-registration process is important to be known, as you need to know when the work needs to be started.

Additionally, you must keep track of any changes in the regulatory requirements of the market in question. There can be changes both in registration requirements as well as changes that need to be reported and/or updated in vigilance reporting requirements.

This brings us to the topic of changes. When you are on multiple markets, your change procedure must include a mechanism for what changes need to be reported to authorities as a change notification or if re-registration is required. And as always, this assessment must be documented in connection with the change.

As you can see the QA department needs to be appropriately staffed if you intend to be on multiple markets. Also, you need to have discipline on device changes so you are not making small, but significant changes continuously that will require a multitude of submissions. This is often the case with software changes. It is better to introduce several changes simultaneously and report the changes in a single submission. That will save a lot of work. But planning is the key.

But with proper planning your company will enjoy the fruits of your gardening for a long time.

Regulatory requirements are a design input.

What is the purpose of developing a medical device?

If you ask your employees, the probable answer is that it is to help patients and fulfill user needs. Which is fair enough, but in order to do that we also need to understand that regulatory and government authorities also are included in the “user needs”.

At the core of every design and development process are the user needs. Too often, however, the user needs are limited to the needs of the patients and/or health care professionals. Regulatory requirements are overlooked except for the immediate market where the manufacturer resides. Your device is CE-marked or 510(k) cleared but the needs on important markets are not included in the design input. This sometimes causes registration problems, costly redesigns, retesting or even registration failure.

Failure in design transfer to production is one of the most common sources of FDA warning letters which has led manufacturers to understand that you cannot just design the product and then throw the drawings over the wall to production and hope everything will be sorted by itself. You need to work together as a team.

Unfortunately, this is still often the case when it comes to registrations. The requirements from the applicable markets are investigated at its best at the design release and a world of trouble opens up causing changes, delays and additional costs. This can however be avoided to a large extent just by understanding that the regulatory requirements are essential in design input

Initial sales strategy
Early in the process an initial sales strategy should be presented with intended use, intended users and the most important markets. The strategy should also include the anticipated sales for the first 3-5 years if possible. Depending on the type of device, health economics and reimbursement requirements should also be investigated.

Regulatory route
The regulatory department can then do an initial assessment of the requirements of each of the proposed markets. This should include the cost and complexity of the registration as well as additional local requirements such as:

  • Classification
  • Product codes
  • Additional labelling requirements?
    • Translations
    • Country specific symbols/labelling needed.
  • The need for a local market representative?
  • Additional QMS requirements including foreign government audits?
  • Additional manufacturer registrations needed?
  • Local standards or testing required?
  • Other local regulations that could affect device registration (radio, battery, animal content)
  • Local demographics required for Clinical or Usability investigations?
  • Should health economics be included in the Clinical study?

With the information above, a cost/benefit analysis can be performed and an informed decision on which markets to pursue and which requirement to include from the start can be pursued. This way the device will be ready for major applicable markets at release rather than trying to squeeze them in later stages.

A successful product realization and launch can be summed up with the famous Plan, Do, Check, Act. However, as you can see, the first word is Plan.