A variety of different medical device information systems are in use worldwide. And every country has its own system for reimbursing medical costs, each with its own specific requirements. We can prepare all the documentation you need to register manufacturers and devices successfully.
Listing & Registration
German Medical Technical Aids Register (HMV)
The Medical Technical Aids Register (Hilfsmittelverzeichnis, or HMV) is the gateway that allows the cost of your device to be reimbursed on the German market. Choosing the right product group for the HMV can be a decisive factor when it comes to market access, as can obtaining a listing quickly and efficiently.
This process is fraught with obstacles. With well over 100 successful applications every year, we know how to navigate this complex precess.
Digital Healthcare Applications (DiGA)
Since 2020, changes to regulations have made it easier to get costs associated with digital healthcare applications (known in Germany by the acronym DiGA) reimbursed by statutory health insurers in Germany. However, the BfArM evaluation procedure must be prepared for well in advance.
We can guide you through this process and prepare the required evidential documents for you.
By virtue of its size, the US market is a major target for international manufacturers. We have been compiling 510 (k) applications and registering companies and products with the Food and Drug Administration (FDA) for more than 15 years. We can work together with our partners to organise market analyses and access strategies.
We can prepare your submission file, communicate on your behalf with the American authorities, and to register you with them, helping your product to achieve international success.
Pharmaceutical Registration Number (PZN)
In Germany, all products commonly available in pharmacies must be assigned a pharmaceutical registration number (Pharmazentralnummer, or PZN). Registration numbers are assigned on the basis of a formal application to the Institut für Arzneispezialitäten, or IFA.
We can make your life easier by dealing with this application on your behalf.
All manufacturers, medical devices and responsible individuals must be appropriately registered. In EU Member States, registration means having your details entered into EUDAMED. EUDAMED registration requires a lot of detailed information.
We can handle the entire registration process for you, making it quick and easy.
In addition to the requirements associated with the CE mark, medical devices are subject to additional national requirements, which vary according to the market segment concerned.
Working together with our international partners, we can help you clear international hurdles by preparing the necessary documentation. We can also communicate on your behalf with authorities and institutions in other countries in Europe and beyond.