Аккредитация на регистрацию по правилам ЕАЭС
Наличие собственной испытательной базы
Богатый опыт наших специалистов
Регистрация медицинских изделий под ключ
Technical tests involve testing to determine whether a medical device meets safety, quality and regulatory
requirements when used for its intended purpose as provided for in the manufacturer’s technical and operational
documentation. Technical tests are a mandatory step in the process of obtaining a Registration Certificate for a
medical device.
MEDALIS can arrange technical tests of a medical device by an accredited safety testing laboratory for technical
equipment run by Eleсtrontest LLC.
Technical tests are performed in accordance with Order No. 2n of the Ministry of Health dated January 9, 2014.
The Order stipulates that technical tests should be performed at the stage of compiling a registration dossier.
Technical tests of a medical device should be performed by an accredited testing laboratory whose reports are
recognized by the central Registration Authority, namely the Federal Service for Surveillance in Healthcare
(Roszdravnadzor).
The purpose of technical testing is to make sure that the medical device is compliant with:
Regulations of the Russian Federation and the EAEU rules for registration of medical devices;
The manufacturer’s technical and operational documentation;
Requirements for quality, safety and efficacy of the medical device.
MEDALIS is part of Eleсtrontest Group; therefore, we guarantee that technical tests will be carried out promptly and at a high level of quality, according to both national and EAEU regulations.
The process of technical testing is divided into three stages:
Upon completion of the technical testing, the Customer will receive all of the above documents, and in particular: Technical Testing Programs, Technical Testing Report, and Technical Testing Assessment Report. These documents, when taken together, confirm the testing results and expert conclusions regarding compliance of the subject medical device with all legal requirements for quality, safety and efficacy.
By hiring MEDALIS, you will get expert services with no agency fees, and consultancy support throughout the registration process of your medical device.
Please contact us by phone at: +7 (495) 455-11-16 (ext. 206) or +7 (919) 777-93-36 to start cooperating today.
The Elecrontest Group of Companies has been operating in the medical device circulation market for more than 10 years. During its existence, more than 600 registration certificates have been successfully obtained.