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Global Registrations

Our global registrations team is the perfect partner for medical device manufacturers seeking smooth, timely and cost-effective registration of their medical devices internationally. We have the proficiency and 20 years of experience to help you comply with the varying regulatory requirements in all countries worldwide.

The international registrations process can be costly, time-consuming and unpredictable for medical device manufacturers. With our proven process we provide support by managing the compilation and preparation of all necessary documents as well as coordinating with local authorities.

ISS Global Registrations

 

Proactive & efficient registration thanks to REGULA™

Regardless of your product portfolio and choice of countries, our proprietary software REGULA™ allows active monitoring and responding to all innovations in every single market worldwide. It supports our team of specialists throughout the registration process including document compilation, preparation and coordination, and registrations. It enables us to keep track of the status and progress of registrations in different countries and to take timely actions.

 

Testimonial

"The ISS AG has effectively supported us in the global registrations of our medical products. For the past 8 years, we have relied on their experienced consulting team, which has been instrumental in successfully registering our products in 88 countries. Thanks to their expertise and proactive approach, we are consistently informed about the latest developments in all countries worldwide and can therefore take timely action. Thanks to the dedicated support of ISS AG, we have been able to achieve our business goals and strengthen our market position. We are extremely satisfied and look forward to a continued successful collaboration."

 

Knowledge is power

The RA team needs to keep track of all national and international regulations and ensure that all requirements are met in order to distribute the product in various countries. ISS has a comprehensive worldwide knowledge management system that allows us to create RA intelligence tailored to your company enhancing your RA processes more efficiently, as our team always stays informed about all regulatory changes and updates in all countries.

 

ISS Global Registrations in figures

years of experience

medical devices registered worldwide

countries, where we register medical devices

 

FAQ’s

What kind of services does ISS AG offer in the area of global registrations?

We coordinate and manage – if desired – the entire registration process from planning, coordination and implementation to re-registration. We support our customers with preparation of registration documents and dossiers, submission and cooperation with local partners and authorities. Our aim is to ensure efficient and cost-transparent processes and timely submissions.

How does ISS AG ensure that the takeover of approvals runs smoothly and that there are no delays?

We have 20 years of experience and proficiency in the field of international medical device approvals. We work closely with manufacturers, local partners as well as the relevant authorities and ensure that projects are realistically planned and competently executed. We provide transparent communication regarding all steps and costs to our customers. In addition, we ensure that all requirements are met in order to guarantee a successful takeover of the approvals. Our REGULA™ submission software guarantees that the necessary overview of ongoing and completed registrations is available at all times.

How long does it take on average to obtain an international medical device registration?

The duration of the approval process depends on factors varies based on the different requirements of the respective authorities in different countries. For example, the target market or the complexity of the product play a decisive role. However, we guide you through the approval process in a targeted and coordinated manner.

Are there any restrictions regarding the type of medical devices?

We support manufacturers of all types of medical devices - from classical medical devices to IVD products.

Is ISS AG active worldwide or limited to certain regions?

We are active globally in all geographic areas and support manufacturers in getting their products approved across various markets and regions. We provide support in large, established markets such as the USA, Brazil as well as in niche markets such as Oman, Chile, or Tanzania.

How does ISS AG manage to keep track of regulatory changes worldwide?

We have an established a comprehensive knowledge management system that records and evaluates global regulatory changes. This information is shared with our expert team and customers allowing us to incorporate the latest findings directly into the approval process and ensure that new regulatory requirements are anticipated at an early stage. Our 20 years of practical experience in conducting global registrations help us to assess the practical implementation of theoretical requirements and to incorporate them into our processes.

 

Global Registrations Flyer

 

Contact

Whether a product or an entire product range - our international registration team ensures that your products can be safely and efficiently registered and marketed in different countries. We will be happy to advise you. Contact us via contact form, by e-mail or directly by phone. We look forward to supporting you!

 

Sandra Item

Sandra Item

Co-CEO
Division Leader Compliance Services
Your contact for strategic topics
Nina Nowka

Nina Nowka

Teamleader International Market Access
Your contact for operational topics