The term “medical product” in Ukraine includes medical products and medical equipment, rehabilitation products, medical products for in-vitro diagnostics and active medical products that are implanted.
From July 1, 2015, the legislative requirements for the introduction of medical devices into circulation changed in Ukraine: there was a transition from the “old” state registration system to the “new” system for assessing compliance with the requirements of the Technical Regulations.
The introduction of the Technical Regulations is due to the harmonization of Ukrainian legislation with European legislation, with the aim of the gradual integration of Ukraine into the European Union. Technical regulations on medical devices are based on the relevant European directives:
Transitional period from registration to certification
From July 1, 2015, a two-year transitional period began to operate, during which the introduction of medical devices into circulation was allowed both on the basis of registration certificates, the expiration date of which has not yet expired, and on the basis of Declarations/certificates of conformity.
Such a transition period made it possible to build up stockpiles in Ukraine and gradually move to fulfilling the requirements of the new legislation. Medical products put into circulation according to registration certificates are allowed for sale until the expiration date of the medical product, but not more than 5 years.
Since July 1, 2017, it has become impossible to put products into circulation based on registration certificates. All medical devices imported and put into circulation must meet the requirements of the applicable Technical Regulations.
Inspection of the design of medical devices for in-vitro diagnostics intended for self-monitoring (for example, pregnancy tests) is carried out by the designated conformity assessment body on the basis of the submitted Application and the package of documents. In case of insufficient data on the conducted research, the appointed body has the right to appoint additional research in an accredited laboratory.
After receiving the project verification certificate, the manufacturer or his authorized representative carries out the “self-declaration” procedure, as well as registration with the State Medical Service before putting the product into circulation.
The audit (inspection) of the manufacturer is carried out by the designated conformity assessment body at the location of the legal manufacturer, and in some cases at the production sites. The procedure consists of several stages and includes the assessment of documentation, agreement on the plan and program of the audit, the audit itself on the spot, drawing up a report (protocol) on the conducted audit and issuing a certificate.
This procedure is quite expensive and time-consuming, but the certificate of conformity can include a very large range of products.
The certificate of conformity is issued for a period of up to 5 years, and is subject to an annual surveillance audit (significantly less time-consuming and cheaper initial).
Batch certification involves evaluation of documentation and laboratory tests, based on the results of which a certificate for a specific delivery (invoice) is issued. This procedure is an alternative for those medical devices that are imported infrequently, or for which it is not possible to audit or recognize the EU certificate.
The procedure is not performed for sterile medical devices, and is also impractical for products with a wide range – each type/type of product increases the cost of testing. Due to the need for delivery to the test site and preparation for operation, it is also quite difficult to carry out party-by-party certification of heavy equipment (MRI, CT, some X-ray machines, etc.).
Recognition of the EU certificate is carried out by the designated conformity assessment body based on Article 45 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”. The recognition is based on a certificate issued by a European notifying authority that has signed a Recognition Agreement with the Ukrainian Designated Conformity Assessment Body.
The recognition procedure is not unconditional, i.e. the manufacturer must fulfill the national requirements (appoint an Authorized Representative, draw up Technical Documentation, fill out a national checklist, draw up a national Declaration, develop labeling and instructions, etc.), after that submit a package of documents for conformity assessment to the designated body. which has the right to partially recognize the results of another body. Since the audit is the most expensive and time-consuming part of the conformity assessment work, it is appropriate to recognize the results of the work on this part.
The certificate of conformity is issued for the period of validity of the European certificate, and is also subject to annual supervision (confirmation of validity).
In addition to the main works, we are also ready to offer: