Registration of medical devices abroad

IPS supports manufacturers in entering overseas markets.

We will help you:

Assess the prospects and the possibility of registering a medical device abroad
Correctly determine the class of a medical device for registration according to the regulations of your selected countries
Choose the optimal scheme for obtaining marking
Choose ways to confirm compliance with international requirements for medical devices
Develop technical documentation in accordance with the standards of the selected country or countries
Organize technical testing, toxicological and clinical studies in accredited laboratories
Collect and submit the registration dossier to the notifying authority

CONFIRMATION OF COMPLIANCE

To register medical devices and preparations, including masks and gloves, it is necessary to confirm that they comply with the regulations of the country of import. For example, for import and sale in Europe, a medical device needs to obtain the CE-marking and confirm that your quality management system complies with the EU standard. Usually - through the international certificate ISO 13485.

Why is it easier to register a medical device abroad with IPS?

Our experienced experts are familiar with the requirements of the EU and other countries and are constantly monitoring the changes in standards.
We have established contacts with international experts, laboratories and attorneys in different countries.
We accompany clients at all stages of registration and take on the difficulties associated with obtaining markings, certificates and registration certificates in the desired country.
Contacting IPS saves you time and resources. We are engaged in registration from and to, and you are simply preparing for the successful import of medical products to markets of interest to you.

Patent attorney

Оформление патентных прав, подача заявок и ведение делопроизводства в российском и различных зарубежных патентных ведомствах;
Представительство в судах, в Палате по патентным спорам;
Проведение патентного аудита предприятия и любых других патентно-правовых исследований;
Разрешение сложных ситуаций, связанных с патентным делопроизводством;