Medical products, according to Ukrainian legislation, are considered devices, equipment, tools, devices, systems, systems, devices, implants and materials, which provide:
- diagnosis, treatment and prevention of disease, monitoring of the patient or his condition alleviation;
- research, replacement or modification of the structure of tissues, organs or physiological processes;
- the process of fertilization control.
The products registered in Ukraine, approved for issuance without a conformity assessment procedure before expiry of the certificate, but not later than July 1, 2017 (depending on what comes first). Implementation of medical devices is permitted until the expiry date of products (but not more than 5 years). For all new (not registered) medical devices and medical equipment from July 1, 2015 it is needed to be assessed by relevant technical regulations.
In order to get a certificate for a medical device, it is necessary to pass certification process of medical devices. This procedure allows you to verify the quality and compliance of the certified product standards.
If we talk about mandatory procedures, the following products are gone through this procedures:
- Medical Products Is (sterile), I with measuring function, IIa, IIb, III classes, according to the Technical Regulations for Medical Devices (Cabinet of Ministers of Ukraine Resolution # 753);
- The reagents, calibrators and controls included in the list of "A" and "B" of the Technical Regulations of medical products for the diagnosis of in-vitro (Cabinet of Ministers of Ukraine Resolution # 754), products for the self-control;
- All medical devices that fall under the Technical Regulation on active implantable medical devices (Cabinet of Ministers of Ukraine Resolution # 755).
For medical products of Ist class (non-sterile, without measuring function), according to the Technical Regulations for Medical Devices (Cabinet of Ministers of Ukraine Resolution # 753), in-vitro medical devices which are not included in the list of "A" and "B" of the Technical Regulations (Cabinet of Ministers of Ukraine Resolution # 754), which are not intended for self-control, in this case self-declaration procedure is applied.
The result of the certification procedure is to obtain a certificate of conformity assessment on the medical device, associated with the certificate for quality management system of the manufacturer and drafting of the Declaration of compliance with the Technical Regulations.
PE"Consulting service plus" has been working on the medical equipment market more that fourteen years. It has the necessary knowledge, ability to carry out the whole spectrum of works on self-declaration and certification of medical products.
We offer you the cooperation in passing the conformity assessment procedures which have been approved by:
- Technical Regulation (Cabinet of Ministers of Ukraine Resolution # 753 from 02.10.2013),
- Technical Regulation (Cabinet of Ministers of Ukraine Resolution # 754 from 02.10.2013),
- Technical Regulation (Cabinet of Ministers of Ukraine Resolution # 755 from 02.10.2013).
If you choose us, you can count on our professionalism, quick time limits and good price.
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