Annex 1

to the Procedure for State Registration of the Medical Devices in Ukraine

Application ¹_____________

for registration of the medical devices

"_______" _____________

I. General Information:

1. Name of the registration object (synonyms, trade name in the original language, in English and Ukrainian);

2. Applicant (applicant’s country of registration, location phone number, telefax, E-mail, National registration number, code of the Unique State Register of Enterprises and Organizations of Ukraine (USREOU code*));

3. Manufacturer (manufacturer’s country of registration, location, phone number, telefax, E-mail, National registration number);

4. Document that authorize the applicant to represent the manufacturer (if the applicant and manufacturer is not the single person – agreement, contract, warrant).

5. MD’s code according to the product range codes of the foreign-economic activity.

II. Certificate of object’s of registration compliance with the established in Ukraine requirements for quality and safety for human health.

Hereby I confirm the products submitted for the registration meet the requirements of quality and safety that were submitted in the in-line documentation and comply with the legislation of Ukraine on quality and safety for human health and environment.


Date __________                            Applicant’s signature _____________

 

List of the Medical Devices that are Subject to the State Registration in Ukraine*

¹ MD’s code according to the product range codes of the foreign-economic activity Product’s Name   1.  2505 10 00 00* siliceous sand and quartz sand   2.  3001 10* glands and other organs that use with the organotherapeutic aim, dried, milled or not milled to powder   3.  3001 90 10 00* other substances of human origin assigned for therapeutic or preventive use   4.  3001 90 99 00* other substances of human or animal origin assigned for therapeutic or preventive use   5.  3005* cotton wool, gauze, bandages and similar products (i.e. bandage material, court plaster, mustard plaster) saturated or covered with pharmaceutical substances, prepared for sale, application in medicine, surgery, dentistry   6.  3006 10* surgical sterile catgut, similar sterile surgical, bandaging, sutural and sterile adhesive fabric that are used in surgery to suppress wounds, sterile linings, sterile styptic agents (haemostatics) that are used in surgery or dentistry   7.  3006 40 00 00 dental cement and other dental materials for tooth filling, cement for bone reconstruction (resumption)   8.  3006 50 00 00 first-aid kits and sets for first medical aid   9.  3306* hygiene facilities for mouth cavity or dents, including powders and pastes for denture; threads for cleaning of the teeth gaps (teeth cleaning threads) packed for sale   10.  3307 90 00 00* solutions for maintenance of contact lens and similar products   11.  3402 20 90 00* detergent and cleansers (at dentistry)   12.  3402 90 90 00* detergent and cleansers (surgery)   13.  3405 90 10 00* polishing tools for the metal surfaces   14.  3407 00 00 00 “dental wax” or mixtures for making of dental moulds packaged in the sets, sale packs or in tablets, bars, plates etc., other products for dental treatment needs made of the plaster (calcined plaster or plaster sulfate)   15.  3701 10 10 00* photo plates and film plates, sensitized, exhibited from any material except paper, cardboard or fabric, for X-ray photography, medical and dental needs   16.  3702 10 00 00* photo films sensitized, exhibited from any material except paper, cardboard or fabric, for X-ray photography   17.  3707 90 30 00* photo chemicals for X-ray films and plates   18.  3816 00 00 00* fireproof cements, similar mixtures   19.  3822 00 00 00* diagnostic, reagents or laboratory reagents with linings or without it   20.  3824 10 00 00* ready-made substances used for production of mold forms or cores   21.  3824 90 65 00* subsidiary products for foundry manufacture (except the items indicated at the point 3824 10 00   22.  3906 10 00 00* Plexiglas   23.  3906 90 90 00* acrylic polymers in primary forms   24.  3923 10 00 00* products of plastic for goods transportation and packing   25.  3923 29 10 00* products of polyvinylchloride for transportation and packing   26.  3923 29 90 00* products of other plastic materials for transportation and packing   27.  3923 30 10 00* flasks, bottles and similar products with the capaciousness no more than 2 litres   28.  3923 50* corks, lids, caps and other devices for capsulation   29.  3924 90 90 00* toilet and sanitary products of plastic   30.  3926 20 00 00* clothing and subsidiary goods (including gauntlets)   31.  3926 90 91 00* products of plastic made of sheet material   32.  3926 90 99 00* silicone soothers, ion-exchanging pumps etc.   33.  4005 99 00 00* products of non-vulcanized elastic mixtures   34.  4009 10 00 00* plain, non-combined with the other materials pipes and hoses without fittings   35.  4014 10 00 00 shell contraceptives   36.  4014 90 10 00 different types of soothers and products for children   37.  4014 90 90 00* sanitary products of vulcanite   38.  4015 11 00 00* surgical elastic gauntlets   39.  4015 19 90 00* elastic gauntlets for medical examination   40.  4015 90 00 00* elastic clothing and other elastic products   41.  4016 99 88 00* products of non-solidified vulcanite   42.  4803 00 10 00* cellocotton   43.  4818 40* sanitary towels, napkins, linings, tampons, diapers for infants, nappies and similar sanitary products   44.  4818 50 00 00* clothing and subsidiary products   45.  4818 90* products used in surgery, medicine etc., non-packed for sale   46.  4819 50 00 00* other packaging   47.  5006 00 10 00* silk threads   48.  5006 00 90 00* catgut of real silk   49.  5402 61 00 00*  yarn of nylon or other polyamides   50.  5601 10* sanitary towels and tampons, children’s diapers and nappies and similar sanitary products of cotton wool, synthetic, artificial and other textile materials   51.  5601 21* wadding of cotton, products of cotton wool   52.  5601 22* wadding of synthetic or artificial fibre   53.  5601 29 00 00* other products of wadding   54.  6115 93 10 00* elastic stockings for the patients with varicose veins disease   55.  6115 93 30 00* plus-fours (except medical stockings)   56.  6115 99 00 00* medical stockings and plus-fourth of other textile materials   57.  6210 10 91 00* clothing in the sterile packaging   58.  6210 10 99 00* other clothing of industrial production   59.  6212 20 00 00* waistbands and pantie-girdle   60.  6212 90 00 00* other bandage products   61.  6307 90 10 00* sanitary products of stockinet   62.  6307 90 99 00* other sanitary products   63.  7010 10 00 00* ampoules   64.  7010 20 00 00* corks, lids and similar products   65.  7010 92 90 00* bottles, flasks for pharmaceutical products with the capaciousness no less than 0.33 litre and no more than 2 litres       66.  7010 93 70 00* bottles, flasks for pharmaceutical products   67.  7010 94 71 00* bottles, flasks for pharmaceutical products with the capaciousness no less than 0.055 litre and no more than 0.15 litre   68.  7010 94 79 00* bottles, flasks for pharmaceutical products with the capaciousness no more than 0.055 litre   69.  7015 10 00 00* glass for spectacles that correct sight   70.  7017* laboratory glassware, sanitary or pharmaceutical, made of glass, divided or non-divided   71.  7108 13 10 00* golden plates used in dentistry   72.  7326 90 97 00* other products of iron of steel   73.  7612 90 10 00* nonseparable cylindrical packaging   74.  8309 90 10 00* lids of aluminium for bottle plugging more than 21 millimeters in diameter   75.  8309 90 90 00* other lids for bottle plugging   76.  8413 20 90 00* hand-operated pumps   77.  8414 10 30 00* vacuum pumps   78.  8414 60 00 00* exhaust hoods (for laboratories)   79.  8414 80 31 00* compressors with the production no more than 60 m3   80.  8414 80 39 00* compressors with the production more than 60 m3   81.  8418 30 91 00* deep-freezers with the capaciousness no more than 400 litres   82.  8419 20 00 00 medical and surgery and laboratory sterilizers   83.  8419 40 00 00* distillation or rectifying stills   84.  8419 89 98 00* laboratory equipment for material processing by means of temperature change   85.  8421 19 91 00* centrifuges used in the laboratories   86.  8421 29 90 00* equipment for liquid filtering or purification   87.  8421 39 30 00* equipment for air filtering or purification   88.  8421 39 98 00* equipment for gas filtering or purification   89.  8423 10 90 00* scales for human weighing including scales for infants   90.  8424 30 10 00* sand spray, steam spray and similar spray machines and devices that work on compressed air   91.  8424 30 90 90* other sand spray and steam spray machines   92.  8456 30 11 00* sputter-ion machines with the wired communication channel   93.  8456 30 19 00* sputter-ion machines   94.  8459 29 00 00* drill machines   95.  8460 21 90 00* polishing machines   96.  8480 10 00 00* flasks and pourings   97.  8480 30 90 00* founding models   98.  8481 80 99 00* aerosol valves   99.  8514 20 10 00* furnaces and induction chambers   100.  8514 20 90 00* furnaces and dielectric chambers   101.  8514 30 99 00* furnaces and laboratory chambers   102.  8515 11 00 00* soldering irons and guns   103.  8515 29 90 00* welding apparatuses   104.  8543 89 95 00* automatic devices for signal processing   105.  8705 90 90 90* special-purpose automobiles, mobile radiological station   106.  8713*  wheelchairs and other devices for invalid transportation, with or without engine or other mobile mechanism   107.  9001 30 00 00* contact lens   108.  9001 40 41 00* lens of glass for spectacles that correct sight, with single focal point, processed from both sides   109.  9001 40 49 00* lens of glass for spectacles that correct sight   110.  9001 40 80 00* lens of glass for spectacles that correct sight, other   111.  9001 50 41 00* lens of other materials for spectacles that correct sight with single focal point, processed from both sides   112.  9001 50 49 00* lens of other materials for spectacles that correct sight, other   113.  9001 50 80 00* lens of other materials for spectacles that correct sight   114.  9003 11 00 00* plastic rims   115.  9003 19 30 00* rims of non-precious metal   116.  9003 19 90 00* rims of other materials   117.  9004 10 10 00* spectacles and other optical devices for sight correction   118.  9004 90 10 00* spectacles with plastic lens   119.  9004 90 90 00* other spectacles   120.  9006 30 00 00* photographic apparatuses for medical internal inspection   121.  9006 59 00 00* other photographic apparatuses   122.  9010 10 00 00* equipment and devices for automatic developing or automatic printing of developed films   123.  9010 50 90 00* other equipment and devices for developing, negatoscope   124.  9011 10 90 00* stereoscopic microscopes   125.  9011 20 90 00* photomicrographic microscopes   126.  9011 80 00 00* other microscopes   127.  9012 10 90 00* electronic microscopes   128.  9013 20 00 00* lasers except laser diodes   129.  9017 30 10 00* micrometers and sliding calipers   130.  9017 30 90 00* hand tools for linear measurement   131.  9018 11 00 00 electrocardiographs   132.  9018 12 00 00 diagnostic equipment for ultrasonic examination (scanners)   133.  9018 13 00 00 magnetic-resonance planigraphs   134.  9018 14 00 00 scintigraphic devices   135.  9018 19 10 00 devices for tracing more than two parameters   136.  9018 19 90 00 other devices for tracing parameters   137.  9018 20 00 00 devices that use ultra-violet or infra-red rays   138.  9018 31 10 00 plastic squirts with or without needles   139.  9018 31 90 00 other squirts   140.  9018 32 10 00 tubular metal needles   141.  9018 32 90 00 needles for putting stitches   142.  9018 39 00 10 catheters   143.  9018 39 00 30 probes   144.  9018 39 00 50 bougies   145.  9018 39 00 90 other surgery devices   146.  9018 41 00 00 dentist machines jointed or not with other dentist equipment on the single base   147.  9018 49 10 00 chisels, disks, mills and brushes for dental boring   148.  9018 49 90 00 other dental devices   149.  9018 50 10 00 ophthalmologic equipment and devices, nonoptical   150.  9018 50 90 00 ophthalmologic equipment and devices, optical   151.  9018 90 10 00 instruments and devices for measurement of arterial pressure   152.  9018 90 20 00 endoscopes   153.  9018 90 30 00 artificial kidney apparatus   154.  9018 90 41 00 ultrasonic devices   155.  9018 90 49 00 other devices for diathermy   156.  9018 90 50 00 equipment and devices for blood transfusion   157.  9018 90 60 00 equipment and devices for anesthesia   158.  9018 90 70 00 ultrasonic lithotryptors   159.  9018 90 75 00 apparatuses for nerve stimulation   160.  9018 90 85 10 devices for infusion of solutions   161.  9018 90 85 90 other devices used in medicine, surgery, dentistry   162.  9019 10 10 00* electronic apparatuses for vibromassage   163.  9019 10 90 00* apparatuses for mechanotherapy   164.  9019 20 00 00 apparatuses for ozonotherapy, oxygen and aerosoltherapy, artificial respiration, reanimation and other devices for respiratory therapy   165.  9020 00 90 00* respiratory apparatuses and gas masks   166.  9021 11 00 00 artificial joints   167.  9021 19 10 00* orthopedic devices   168.  9021 19 90 00 devices for fracture treatment    169.  9021 21 10 00 artificial dents of plastic materials   170.  9021 21 90 00 artificial dents of other materials   171.  9021 29 00 00* component for dent prosthesis   172.  9021 30 10 00 artificial (glass) eyes   173.  9021 30 90 00* other parts of body, artificial   174.  9021 40 00 00* apparatuses for hearing improvement except components and devices   175.  9021 50 00 00 heart stimulants except components and devices   176.  9021 90 90 00* other orthopedic devices   177.  9022 12 00 00 computer planigraphs   178.  9022 13 00 00 devices fro use in dentistry   179.  9022 14 00 00 other devices used in medicine, surgery   180.  9022 19 00 00* devices that use X-radiation for other aims   181.  9022 21 00 00 devices that use alpha, beta or gamma rays for use in medicine, surgery   182.  9022 29 00 00* devices that use alpha, beta or gamma rays for other use   183.  9022 30 00 00* X-ray tubes   184.  9022 90 10 00* X-ray screens luminescent, X-ray screens, intensifying screens and anti dispersion nettings   185.  9022 90 90 00* other devices used in medicine   186.  9025 11 91 00 medical thermometers   187.  9025 19 91 00* electronic thermometers   188.  9027 20 10 00* gas chromatographs   189.  9027 20 10 90* other chromatographs   190.  9027 20 90 00* apparatuses for electrophoresis   191.  9027 30 00 10* nuclear and stripping spectrophotometers   192.  9027 30 00 90* other spectrophotometers   193.  9027 50 00 00* other devices and apparatuses that use optical radiation (ultra-violet, visible, infra-red)   194.  9027 80 11* electronic pH-meters and other apparatuses for measuring of electroconductivity   195.  9027 80 91 00* viscameters, devices for measuring of porosity and distension   196.  9027 80 97 00* other devices for physical or chemical analyses   197.  9027 90 10 00* microtomes   198.  9030 10 90 00* devices and apparatuses for measuring and revealing of ionizing radiation   199.  9032 10 91 00* thermostats with electric starting device   200.  9033 00 00 00* components and devices of the machines, apparatuses of the item 90 that are not included to other items   201.  9402 10 00 00 dental chair   202.  9402 90 00 00* medical and surgery furniture   203.  9405 40 10 00* searchlights (operation lamps)   204.  9506 99 90 00* devices and equipment for therapeutic physical training   205.  9603 21 00 00* toothbrushes including brushes for artificial teeth   206.  9616 10 10 00* sanitary sprayers   207.  9616 10 90 00* nozzles and heads for the sanitary sprayers