1. Necessary consultations on the requirements of the Technical Regulations, the list of necessary documents and the procedure for their preparation, execution, revision, the need to obtain additional conclusions/examinations, as well as the assessment of your existing documents for completeness and correctness
2.Assistance or full drafting of the Agreement or the Power of Attorney for the appointment of an Authorized Representative in Ukraine, or both, at your request
3.Preparation of documentation for the Ukrainian market, including labeling, instructions for use, declaration of conformity, notification, and cover letter for submission to the State Service of Ukraine on Medicines and Drugs Control
4.Submission and registration to the State Service of Ukraine on Medicinal Products, full support, and closure of work only after entry into the register;
5.Consultations for manufacturers and authorized representatives on further handling and maintenance of registration documents (amendments, shortening, and extension of the declaration), response to complaints and incidents regarding registered medical devices
6. Translation of the required documents.
IF YOU HAVE ANY QUESTIONS, THE COMPANY’S SPECIALISTS WILL PROVIDE CONSULTATIONS FREE OF CHARGE
Self-declaration is the approved name of one of the conformity assessment procedures used for the safest medical devices.
For medical devices of the 1st risk class according to Annex 2 of the Technical Regulations on Medical Devices approved by the Cabinet of Ministers of Ukraine No. 753 and medical devices for in vitro diagnostics that are not included in the lists A and B and are not self-monitoring devices, the self-declaration process is carried out.
Class I medical devices, not sterile, without measurement function;
Medical devices for in vitro diagnostics (analyzers, reagents, calibrators, controls) that are not included in the list “A” and “B” and are not intended for self-control.
The manufacturer and/or its authorized representative independently carry out internal control over compliance with the requirements of the Technical Regulations, issue a declaration of conformity and submit documents for registration to the State Service of Ukraine on Medicines and Drugs Control (SMDC). All responsibility for internal control lies with the manufacturer and/or its Authorized Representative.
The detailed procedure is described in Annex 8 to the Technical Regulations on Medical Devices and Annex 3 to the Technical Regulations on Medical Devices for In Vitro Diagnostics. The list of basic requirements for medical devices is provided in Annex 1 “Basic Requirements” of each technical regulation. The procedure for registration in the State Register is confirmed by the Order of the Ministry of Health of Ukraine No. 122 dated 10.02.2017.
The basis for the qualitative completion of this procedure is the preparation of technical documentation for a medical device or a medical device for in vitro diagnostics, storage, and maintenance of its relevance during the validity period of the declaration registered with the SMDC.
As part of this procedure, one of the important aspects is to obtain confirmation from the designated conformity assessment body of the expert opinion on the medical device’s classification as well as confirmation of its risk class. This is important both for registration in the SMDC and for tenders, customs clearance, and, accordingly, during inspections by market surveillance.
