Issues associated with putting into circulation and/or operation of medical devices in Ukraine are regulated by the State Service of Ukraine on Medicines and Drugs Control. In accordance with the Decrees of the Cabinet of Ministers of Ukraine No. 753, 754, 755 of October 02, 2013, 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 No. 753, 754, 755 of October 02, 2013 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). The Ukrainian regulations on medical devices have not been complied with MDR (new European regulations) yet. They are expected to be changed and complied with MDR within about 2 years.
POSSIBLE WAYS OF CONFORMITY ASSESSMENT
Referring to said legislative acts depending on the type of a medical device the following ways of conformity assessment thereof are stipulated in Ukraine:
- 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 an 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 an 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 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 unilateral recognition of conformity assessment of medical devices, it is possible to conduct conformity assessment of said medical device within the simplified procedure of recognition of EC Certificate without conducting an inspection of a manufacturing site of said medical device by the notified body of Ukraine).
According to the Ukrainian regulations a foreign manufacturer must have its authorized representative with registered office in Ukraine and provide this information in documents for conducting conformity assessment procedures. In case of absence of such 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 an authorized representative should act not less than 5 years.
Documents required for conformity assessment
Ⅰ. The self-declaration procedure does not require submission of documents or any examination procedures, except for notifying the State Service of Ukraine on Medicines and Drugs Control. To achieve conformity of relevant medical devices to the national Technical regulations it is necessary to designate an authorized representative of a manufacturer in Ukraine, fill in technical documentation in accordance with the requirements of the relevant national Technical regulations and applicable procedure, issue a Declaration of Conformity to the Technical regulations, put the symbol of national conformity, name and address of the authorized representative at a labeling of the medical device and submit a notification with the authorized representative’s name, address and medical devices list to the State Service of Ukraine on Medicines and Drugs Control.
Ⅱ. For conducting the examination of Quality Assurance System, as well as Design examination it is necessary to submit an application to the notified body of Ukraine with the following documents attached:
- legalized Power of Attorney from the manufacturer to the authorized representative registered in Ukraine or copy of a contract between the manufacturer and the authorized representative;
- Power of Attorney from the authorized representative to a 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 a Quality Manual of the legal product manufacturer;
- certified copy of a risk management report;
- certified copy of a preclinical evaluation report(s);
- certified copy of a clinical evaluation report(s);
- copy of a product expiration date confirmation report (stability test report);
- drafts of consumer package labeling for the Ukrainian market;
- initial labeling for the EU market in case labeling for the Ukrainian market will be affixed in addition to an existing labeling for the EU market (as a sticker etc.);
- draft of an instruction for use (user’s manual) for the 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 an application to the notified body of Ukraine with the following documents attached:
- 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).
Validity term
The Certificate about conformity assessment of a medical device in Ukraine is valid for 5 years. 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.
For more detailed information, including the costs associated with conformity assessment of medical devices in Ukraine, list of documents required for submission as well as a template of Power of Attorney for execution, etc. please contact our specialists.
