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Conformity assessment of medical devices in Ukraine

Issues associated with putting into circulation and / or the operation of medical devices in Ukraine is regulated by the State Administration on Medicines and Drugs Control of Ukraine. In accordance with the Decrees of the Cabinet of Ministers of Ukraine of October 02, 2013 No. 753, 754, 755 medical devices are allowed for use in Ukraine only after conducting the procedure of conformity assessment.

The requirements of the Decrees of the Cabinet of Ministers of Ukraine of October 02, 2013 No. 753, 754, 755 are based on the relevant EU Directives (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices; Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices; Council Directive 90/385/EEC of 20 June 1990 on the approximation of active implantable medical devices).

Referring to said legislative acts depending on the type of a medical device the following ways of conformity assessment thereof are stipulated in Ukraine, namely:

  • Self-declaration procedure (for non-sterile medical devices of class 1 without measuring functions as well as for analyzers, reagents and other IVD products, which are not included in the lists “A” and “B” of the Technical regulations on in-vitro diagnostic medical devices);
  • Examination of Quality Assurance System including conducting the inspection of a manufacturing site of a medical device by the notified body of Ukraine (for any type of a medical device of classes 1, 2a and 2b except for non-sterile medical devices of class 1 without measuring functions);
  • Design examination together with examination of Quality Assurance System including conducting the inspection of a manufacturing site of a medical device by the notified body of Ukraine (for medical devices of class 3 as well as for medical devices for in vitro diagnostics and active implantable medical devices).
  • Recognition of EC Certificate (in case of the presence of EC Certificates issued for a medical device by one of the notified bodies of the EU Member States, with which the notified body of Ukraine concluded the Agreement on Conformity Assessment and Acceptance of Industrial Products, it is possible to conduct conformity assessment of said medical device within the frame of the simplified procedure of recognition of EC Certificate without conducting the inspection of a manufacturing site of said medical device by the notified body of Ukraine).

Also we would like to draw your attention to the fact that according to the Ukrainian legislation a foreign manufacturer must have its authorized representative with registered office in Ukraine and provide this information in the documents for conducting conformity assessment procedures. In case of absence said representative at your side we may provide the service on acting as the authorized representative of the manufacturer in Ukraine. Please note that according to the Ukrainian legislation the authorized representative should act not less than 5 years.

Ⅰ. The self-declaration procedure does not require submission of documents or any expertise procedures, except notifying the State Administration on Medicines and Drugs Control of Ukraine. To achieve conformity of relevant medical devices to national Technical regulations it is necessary to designate the authorized representative of the manufacturer in Ukraine, fill the technical documentation in accordance with the requirements of relevant national Technical regulation and applicable procedure, issue the Declaration of Conformity to Technical regulations of Ukraine, put the symbol of national conformity, name and address of the authorized representative at the labeling of a medical device and submit a notification with the authorized representative’s name, address and medical devices list to the State Administration on Medicines and Drugs Control of Ukraine.

Ⅱ. For conducting examination of Quality Assurance System as well as Design examination it is necessary to submit the application form to the notified body of Ukraine with the following attached documents:

  • legalized Power of Attorney from the manufacturer to the authorized representative registered in Ukraine or copy of the contract between the manufacturer and the authorized representative;
  • Power of Attorney from the authorized representative to the representative in respect of regulatory affairs actions if different;
  • letter from the authorized representative in Ukraine regarding acceptance of the obligations given by the power of attorney (if applicable);
  • certified copy of the Quality Manual of the legal product manufacturer;
  • certified copy of the risk management report;
  • certified copy of the preclinical evaluation report(s);
  • certified copy of the clinical evaluation report(s);
  • copy of the product expiration date confirmation report (stability test report);
  • drafts of consumer package labeling for the Ukrainian market;
  • initial labeling for EU market in case labeling for Ukrainian market will be affixed in addition to existing labeling for EU market (as sticker etc.);
  • draft of instruction for use (user’s manual) for Ukrainian market;
  • draft of declaration of conformity for Ukrainian market;
  • certified copy of the declaration of conformity to the relevant EU Directive requirements (if available);
  • essential requirements check-list of product compliance with the main requirements of the Annex 1 of the relevant technical regulations;
  • essential requirements check-list of product compliance with the requirements of the relevant EU Directive (if available);
  • legalized copies of the QMS certificate(s) of conformity to the requirements of ISO 9001, ISO 13485 (if available)
  • certified copy of a technical file for each product type included in the application (for conducting design examination procedure only);
  • certified copy of a design dossier for each product type included in the application (for conducting design examination procedure only).

Ⅲ. For conducting the simplified procedure of recognition of EC Certificate it is necessary to submit the application form to the notified body of Ukraine with the following attached documents:

  • legalized Power of Attorney from the manufacturer to the authorized representative registered in Ukraine or copy of the contract between the manufacturer and the authorized representative;
  • Power of Attorney from the authorized representative to the representative in respect of regulatory affairs actions if different;
  • letter from the authorized representative in Ukraine regarding acceptance of the obligations given by the power of attorney (if applicable);
  • legalized copy of EC Certificate issued for a medical device by one of the notified bodies of the EU Member States;
  • drafts of consumer package labeling for the Ukrainian market;
  • initial labeling for EU market in case labeling for Ukrainian market will be affixed in addition to existing labeling for EU market (as sticker etc.);
  • draft of instruction for use (user’s manual) for Ukrainian market;
  • draft of declaration of conformity for Ukrainian market;
  • certified copy of the declaration of conformity to the relevant EU Directive requirements (if available);
  • essential requirements check-list of product compliance with the main requirements of the Annex 1 of the relevant technical regulations;
  • essential requirements check-list of product compliance with the requirements of the relevant EU Directive (if available);
  • certified copy of the certification and last surveillance audit report;
  • letter or any other type of confirmation from the EU notified body on the validity of certificate and, in some cases, with explanation of its scope;
  • legalized copies of the QMS certificate(s) of conformity to the requirements of ISO 9001, ISO 13485 (if available).

The Certificate about conformity assessment of a medical device in Ukraine is valid for 5 years.Please note that within the validity of said certificate supervisory audits will be conducted annually by the notified body of Ukraine.

The validity term of the conclusion on recognition of EC Certificate may not exceed the term of said certificate issued by the notified body of the EU Member State.

In order we could provide you with the information on costs associated with conformity assessment of medical devices in Ukraine together with the detailed information and list of documents required from your side, the Power of Attorney form for execution, etc. please contact our specialists.

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