Self-declaration is an approved term for one of the conformity assessment procedures used for the safest medical devices.
The most significant advantage of the “recognition” procedure is avoiding on-site audits of the manufacturer’s QMS.
The process of conformity assessment by conducting audits of the manufacturer’s QMS is the most common way to confirm the conformity of medical devices of high-risk classes.
ISO 13485 is a quality standard for medical device manufacturers that establishes requirements for a QMS to ensure compliance with customer and regulatory requirements.
Technical documentation is required for all risk classes of medical devices (class I, Is, Im, IIa, IIb, III), all classes of medical devices for in vitro diagnostics (IVD A, IVD B, group “other”), and active implantable medical devices.
An authorized representative represents a foreign manufacturer in Ukraine, including cases of interaction with assessment and compliance authorities, tax authorities, control on the medicines market, etc.
Our experts possess extensive knowledge and experience in the field of medical equipment certification. They know the procedures and requirements necessary to acquire the requisite certificates and licenses.
We always comply with the requirements of legislation and standards, giving our customers confidence that their equipment will obtain the necessary certificates and licenses without any problems.
We strive to ensure high customer satisfaction, so we are always in touch with them, providing detailed information about the certification process and answering all
their questions.
We provide a wide range of services in the field of medical registration, quality control, and certification of medical devices. This includes advising on the production and putting into circulation of medical devices, obtaining expert opinions from the Expert Organizations and the State Expert Center, developing documentation for medical devices, and developing quality management systems in accordance with the requirements of ISO 13485, 9001, 22000, conducting audits, assessing the conformity of devices through audits, etc.
Pharmagent provides quality management system support services in accordance with the requirements of ISO 13485, 9001, and 22000 standards. We assist our clients in developing, implementing, and maintaining quality management systems, conducting diagnostic audits, and internal audits of the quality management system.
We compile documentation for the Ukrainian market, which includes labeling, instructions for use, declaration of conformity, notices, and a cover letter for submission to the STATE SERVICE OF UKRAINE on Medicines and Drugs Control. We also draft various types of contracts as required, and provide translation services for necessary documents.
Consultations for manufacturers and authorized representatives on further handling and maintenance of registration documents (amendments, shortening, and extension of the declaration), and response to complaints and incidents regarding registered medical devices. Consultations on the implementation of quality management systems and their implementation.
Conformity assessment of foreign products through the audit of the quality management system. Conformity assessment of foreign manufacturers through the recognition of certification by notified bodies of the EU. Conformity assessment of domestic manufacturers. Conformity assessment through self-declaration.
