Medical devices are pivotal in advancing healthcare, and trading or selling these devices requires navigating complex regulatory landscapes. This is where AK STATT excels – with profound knowledge, extensive experience, and strong institutional support, we ensure a swift, effortless, and straightforward registration process for your medical devices in Serbia, Bosnia and Herzegovina, Montenegro, Croatia, and North Macedonia.

Phase I: Pre-Registration Activities in Four Steps

1. Regulatory Information Gathering

Our team at AK STATT employs a multidisciplinary approach to gather information about registered medical devices, assessing the potential for new device registrations. We thoroughly understand and interpret the regulations of Serbia and neighboring countries, developing strategic market access solutions.

You can expect us to transform the complexity of regulatory information into clear, actionable insights. We diligently gather and interpret data on registered medical devices, offering you a strategic roadmap tailored to your specific needs in the Balkans.

2. Documentation Preparation

Expertise and meticulous preparation of dossiers by AK STATT lead to a more efficient registration process, accelerating the approval of your medical device. So, with AK STATT, documentation preparation becomes a breeze. Our experts handle every detail with efficiency and precision, significantly shortening the registration timeline and paving the way for a quicker market entry for your medical device.

3. Expert Translations

We provide high-quality translation services for essential documents like Instructions for Use (IFU), packaging texts, marketing materials, and other regulatory documents, ensuring medical accuracy and compliance.

So, relax as we take care of all your translation needs. Our professional translators ensure that every document, from IFU to marketing materials, is accurately translated and culturally aligned, easing your path to compliance.

4. Registration Application Submission

Experience effortless coordination with regulatory bodies as AK STATT expertly manages your application. We meticulously check your documentation for completeness and accuracy, liaising with ALIMS, CINMED, and other agencies, ensuring a smooth and hassle-free submission process.

So, AK STATT meticulously checks the completeness and accuracy of your documentation before submission. We coordinate these activities with regulatory bodies including the Serbian Agency for Medicines and Medical Devices (ALIMS), the Montenegrin Agency for Medicines and Medical Devices (CINMED), the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina, the Macedonian Agency for Medicine and Medical Devices (MALMED), and the Croatian Agency for Medicinal Products and Medical Devices (HALMED), ensuring a smooth registration process across the region.

Phase II: Monitoring the Registration Process in Three Steps

1. Documentation for Submission

AK STATT prepares and organizes documentation for submission to the relevant regulatory bodies in Serbia and the region, ensuring that every detail is accounted for.

In other words, entrust your documentation to AK STATT, where we meticulously prepare and organize every aspect for submission. Our thorough approach leaves no stone unturned, ensuring a flawless and streamlined process.

2. Addressing Assessment Deficiencies

We proactively identify and resolve any issues during the formal and substantive assessment phases, ensuring a seamless registration journey. Navigate through assessment challenges with ease. Our team proactively addresses any potential issues, offering solutions that keep your registration journey on track and uninterrupted.

3. Continuous Professional Support

Our team provides ongoing expertise and support throughout the entire registration process, standing by your side at every step. Throughout the registration process, enjoy the peace of mind that comes with constant support from AK STATT. Our commitment to your success means you have a knowledgeable and dedicated partner at every step.

Phase III: Post-Registration Activities in Two Steps

1. Amendments, Additions, and Registration Renewal

AK STATT supports you throughout your medical device’s lifecycle, managing all modifications and renewals efficiently and effectively. Stay ahead in the ever-evolving medical device sector with AK STATT’s ongoing support. We effortlessly manage any amendments or renewals, ensuring your medical device remains compliant and competitive throughout its lifecycle.

2. Medical Device Vigilance

As vigilance regulations evolve, particularly in alignment with European standards, AK STATT is here to guide you through adapting to new regulatory requirements, ensuring compliance and patient safety. In the dynamic field of medical device vigilance, AK STATT is your anchor. We guide you through adapting to new regulatory requirements with ease, ensuring that compliance is always within reach and patient safety is paramount.

Conclusion

Partnering with AK STATT for medical device registration in the Balkans means more than just navigating regulatory complexities; it’s about joining hands with a leader in regulatory excellence. We make the journey not just successful but also remarkably smooth and stress-free.

Choosing AK STATT for your medical device registration needs in the Balkans means embracing a journey defined by ease, expertise, and excellence. We turn regulatory challenges into smooth transitions, ensuring your path to market success is as comfortable as it is successful.