AUTHORIZED REPRESENTATIVE SERVICES FOR MANUFACTURERS OF MEDICAL PRODUCTS

A Manufacturer of medical devices or medical equipment that plans to supply its products to Ukraine is required by local law to have an "Authorized Representative" in Ukraine. The function of the "Authorized Representative" may be performed by: a selected distributor, representative office or specialized company - a resident of Ukraine. The "Authorized Representative" acts on the basis of the Power of Attorney or the Agreement with the Manufacturer.

 

Functions of the Authorized Representative:

1. Represents Manufacturers interests in relations to the state supervisory authorities and conformity assessment bodies.

2.  According to the order of the Ministry of Health, the Authorized Representative is registered in State service of Ukraine on medicines and drugs control (for the I class risk and in-vitro diagnostic products only).

3. The Authorized Representative monitors the changes in the Ukrainian law and informs the Manufacturer about changes concerning medical products promptly. Please note: since May 25, 2019, a new Law of Ukraine "On ensuring the functioning of the Ukrainian language as a state" came into force.

4. Organizes the translation of the Documentation from the language of the Producer to Ukrainian or English language, depending on the requirements of the legislation. Organizes transcription and transliteration of the own product names, etc.

5. Keeps the Documentation for the manufacturer's products for 5 years, and for active implantable medical products - 15 years. At the request of the State cervices, submits these documents for inspection.

6.  A Representative is authorized to post marketing supervision, deal with complaints from consumers and doctors.

MEDICAL DEVICES AND MEDICAL EQUIPMENT REGISTRATION IN UKRAINE

 

Since 2015, the procedure of medical equipment and medical devices state registration has been canceled in Ukraine. For the introduction of these goods into Ukrainian market, the Manufacturer must pass the procedure of conformity assessment of medical products with the following Technical Regulations:

• No. 753 concerning medical products

• No. 754 concerning medical products for "in vitro" diagnostic

• No. 755 concerning active implantable medical devices

 

Links to the Regulations on the website of the Verkhovna Rada of Ukraine:

https://zakon.rada.gov.ua/laws/show/753-2013-%D0%BF

https://zakon4.rada.gov.ua/laws/show/754-2013-%D0%BF

https://zakon.rada.gov.ua/laws/show/755-2013-%D0%BF

 

Conformity assessment is carried out by the conformity assessment bodies accredited by the National Accreditation Agency of Ukraine (NAAU).

 

CONFORMITY ASSESSMENT PROCEDURE:

 

1. The manufacturer chooses a conformity assessment body. They differ in the cost of services and accreditation. Only a few bodies are accredited to issue certificates for medical products that are covered by all three Technical regulations (№753, 754, 755)

2. The manufacturer submits an application for conformity assessment of medical devices with technical regulations and. If III risk class products / IVD products from list A / IVF for a salf-controle are involved, - the manufacturer additionally submits an application for a design examination. in

3. In annex to the application have to be the list of devices that are subject to certification.

4. The conformity assessment body informs the State Service (State Service of Ukraine on Medicines and drugs control) about acceptance of the application from a particular manufacturer (after applying to change the conformity assessment body is impossible).

5. Both sides sign the contract, agree the dates of the audit on manufacturing, the manufacturer pays for conformity assessment services.

6. The manufacturer and its authorized representative transfer to the conformity assessment body all the necessary documents for checking (labels, instructions, technical files of medical devices, etc.).

7. After verification of documents, auditors go to the country of the manufacturer for certification audit of all production sites.

8. If no violations are detected during the audit, the conformity assessment body issues certificates for a period of 5 years. In the case of risk class III products, IVD products from List A, IVD products intended for self-control, a design examination certificate is also issued, but for a period of 3 years.

9. If violations are found, manufacturer is given time to resolve them. Audit repeats. Once a year, the notified body re-directs auditors to manufacture for the supervision audit.

10. Additionally, products of risk classes: 1s (sterile products), 1m (with a measuring function), IVD (from List A and B, as well as those intended for self-control) must be registered with the State Service of Ukraine on Medicines and Drugs Control.

 

Regularly all process of conformity assessment procedure takes 1-3 months.

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CE CERTIFICATES RECOGNITION

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Technical regulations № 753, 754, 755 for medical products dated 02.10.2013 are based on Directives of the European Union 93/42 / ЕЕС, 98/79 / ЕС, 90/385 / ЕЕС. These documents are very similar, but not identical. Therefore, Manufacturer must pass the national conformity assessment procedure. Although some conformity assessment bodies recognize CE Certificates of the EU Notified Bodies. For the Manufacturer the "Recognition" procedure is much cheaper and faster than the usual conformity assessment procedure.

 

Certification in Ukraine can be done through the recognition of the CE Certificate, if your products are Certified by one of the following notified bodies:

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1.  TÜV SUD Product Service GmbH (0123)

2.  TÜV Rheinland LGA Products GmbH (0197)

3.  TÜV NORD Polska Sp. z o.o (2274)

4.  TÜV NORD CERT GmbH (0044)

5.  BSI Assurance UK Limited (0086)*

6.  BSI Group The Netherlands B.V. (2797)

7.  DEKRA Certification B.V. (0344)

8.  DEKRA Certification GmbH (0124)

9.  DQS Medizinprodukte GmbH (0297)

10. ITALCERT S.r.l. (0426)

11. Kiwa Cermet Italia S.p.a. (0476)

12. Kiwa Belgelendirme Hizmetleri A.Ş. (1984)

13. Lloyd’s Register Quality Assurance (LRQA) (0088)*

14. Eurofins product testing Italy s.r.l (0477)

15. Intertek Semko AB (0413)

16. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (0318)

17. Elektrotechnický zkušební ústav, s.p. (EZÚ) (1014)

18. GMED SAS (0459)

19. SLG Prüf – und Zertifizierungs GmbH (0494)

20. Bureau Veritas Italia S.P.A. (1370)

21. Presafe Denmark A/S (0543)

22. Szuutest Uygunluk Değerlendirme A.Ş. (2195)

23. IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. (0051)

24. UL INTERNATIONAL (UK) LTD (0843)*

25. RISE Research Institutes of Sweden AB (0402)

26. ICIM S.p.A. (0425)

27. CE Certiso Orvos - és Kórháztechnikai Ellenőrző és Tanúsító Kft. (2409)

28. MDC Medical Device Certification GmbH (0483)

29. DNV MEDCERT Gmbh (MEDCERT) (0482)

30. DNV Product Assurance AS (2460)

31. Ente Certificazione Macchine S.r.l. (1282)

32. Polish Centre for Testing and Certification (1434)

33. SGS Belgium NV (1639)

* As the UK has left the EU, it is currently not possible to recognize Certificates issued by UK notified bodies.

 

EU CERTIFICATE RECOGNITION PROCEDURE:

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1. Choosing of conformity assessment body. Among dozens of conformity assessment bodies, CE Certificates recognition can be issued by only few bodies.

2. Preparation of documents (labels, instructions, check-list, etc.). The documents set for the CE Certificates Recognition is much shorter compared to the procedure of conformity assessment by production audit.

3. Translation of a certain part of the documentation in Ukrainian. On May 25, 2019, a new law "On ensuring the functioning of the Ukrainian language as a state" is in force in Ukraine. The documents must comply with the requirements of the Law.

4. After checking the documents by the auditors, the Manufacturer obtains a certificate for the list of products specified in the CE Certificates.

5. The manufacturer must adjust the labels and instructions. They must include the name and address of the Authorized Representative, as well as the National Sign of Conformity

6. Drafting and signing of the National Declaration of Conformity and its annexes.

 

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