Certification of medical devices

Necessity of state certification (UkrSEPRO) of medical devices has been discussed many times, but till 2011 obligatory certification existed only for syringes and cotton-gauze products. In fact obligatory certification of some groups of medical devices has been implemented by Decree of Cabinet of Ministers of Ukraine No 815 as of 05.08.2009. Thus, obligatory certification of medical devices is applied to products under custom commodity codes 3005, 5280, 9018, 9022 and 9402. Full list of medical devices that are objects of obligatory certification is given at the end of the page.   Certification is performed after state marketing authorization. Aim of the certification is to confirm compliance of the product to Ukrainian quality standards.  Certificate of conformity for Ukrainian quality standards (hereinafter - certificate of conformity) is issued for the batch, for one year, to 3 years and up to five years, depending on the chosen certification system. Applicant has the right to decide what certification scheme should be applied.

Certificate of conformity for the batch of medical devices is issued for exact delivery of medical devices to Ukraine (number of the Invoice is mentioned in the certificate) upon examination and expertise of samples of the products. 

Certificate of conformity for serial manufacture of medical devices is issued for 1 calendar year upon documentary expertise as testing of samples. 

Certificate of conformity for serial manufacture of medical devices with inspection of manufacturing site is issued for 2 years upon documentary expertise and inspection of manufacturing site. Certifiate of conformity can be issued for 3 years in case of attestation of the manufacturing site. 

Certificate of conformity for quality management system if the whole manufacturing site is issued up to 5 years upon comprehensive expertise of quality management system and inspection of manufacturing site. 

Certificates of conformity for manufacturing sites located in CIS can be recognized by simplified and cheap procedure.

Certification of medical devices is very complicated procedure. Correct certification requires excellent knowledge of Ukrainian and international legislation, knowledge of the particularities of certification process, experience of such works. Most companies trust certification issues only to regulatory specialists.  

Cratia will organize procedure of certification for national compliance of medical devices from the moment of your first inquiry till transfer of original certificate. We are experienced team of professionals with excellent knowledge of legislation and outstanding relations with state authorities.  

You can contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office. 

List of medical devices that are subjects to mandatory certification for compliance to national standards: 

Group 3005:

3005 Cotton wool, gauze, bandages and similar articles (for example, dressings, adhesive plaster, sinapism), impregnated or covered with pharmaceutical substances, prepared for retail sale and use in medicine, surgery, dentistry;

Group 5208:

5208 11 10 00 cotton cross-woven unbleached fabrics (huck) with surface density not more than 100 g/m² for medicinal dressing, bandage, and gauze fabrication;

5208 21 10 00 cross-woven bleached fabrics with surface density not more than 100 g/m² for medicinal dressing, bandage, and medicinal gauze fabrication;

Group 9018:

9018 11 00 00  Electrocardiographs;

9018 12 00 00  Diagnostic equipment for ultrasonic examination (scanners) and their components

9018 13 00 00  MRI tomographic scanners and their  components

9018 14 00 00  Scintigraphic equipment

9018 19 10 00  Equipment and devices used in medicine, surgery, dentistry for the simultaneous monitoring of two or more parameters 

9018 19 90 00  Devices for parameter monitoring

9018 20 00 00  Equipment based on the use of ultraviolet or infrared radiation.

9018 31 10 00  Plastic syringes with or without needles

9018 31 90 00  Syringes

9018 32 10 00  Tubular metal needles

9018 32 90 00  Suture needles

9018 39 00 10   Catheters

9018 39 00 30  Tubes

9018 39 00 50  Pathfinders

9018 39 00 90  Cannula and similar  accessories

9018 41 00 00  Drilling machine combined or not combined with other dental equipment on a common basis. Machines and devices that run on compressed air used in dentistry

9018 49 10 00   Chisels, drills, disks, heads and brushes for use in dental drilling machines

9018 49 90 00  Dental equipment

9018 50 10 00   Non-optical ophthalmologic devices and equipment

9018 50 90 00  Optical ophthalmologic devices and equipment

9018 90 10 00  Devices and equipment for arterial pressure measurement

9018 90 20 00  Endoscopes and their parts

9018 90 30 00  Hemodialysis equipment (artificial kidney, artificial kidney machines and dialyzers)

9018 90 41 00  Ultrasonic equipment designed for diathermy

9018 90 49 00  Equipment for diathermy

9018 90 50 00  Equipment for blood transfusion

9018 90 60 00  Anesthesia devices and equipment

9018 90 70 00  Lithotriptors ultrasonic

9018 90 75 00  Equipment for nervous stimulation

9018 90 85 10  Devices and equipment for solution infusion

9018 90 85 90  Equipment used in medicine, surgery, dentistry; devices for suction and injections, colostomy and urine bags, devices for opaque injections; intrauterine contraceptives

Group 9019:

9019 10 10 00  Vibromassage electrical apparatus

9019 10 90 00  Mechanotherapy apparatus

9019 20 00 00  Equipment for ozone therapy, oxygen and aerosol therapy, artificial respiration, resuscitation and other equipment for respiratory therapy

Group 9022:

9022 12 00 00  Computer tomographic scanners and their components

9022 13 00 00  Dentistry equipment

9022 14 00 00  Medical, surgical equipment

9022 19 00 00  Equipment that employs X-rays for other purposes

9022 21 00 00  Equipment that employs alpha-, beta-, or gamma-rays for use in medicine, surgery

9022 30 00 00  X-ray tubes

9022 90 10 00   X-ray fluorescent screens, X-ray screens, intensifying screens,  and anti-diffusion  screens

9022 90 90 00  Equipment for use in medicine

Group 9402:

9402 10 00 00 Dental chairs

9402 90 00 00 Furniture medical, surgical and its components

You have any questions? Or you are ready to start cooperation? Contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office.