Ukraine. Procedure for state registration of medical equipment and medical products

Pursuant to the current legislation medical products are devices, systems, equipment, appliances, instruments, applications, implants, tools, materials or other products, including invasive medicinal products; medicinal products for diagnostics in vitro; medicinal products not reaching anticipated goals in human organism or on it with help of pharmacological, immunobiological or metabolic drugs but contributing to functions thereof; medical products used separately or in combination, including software tools necessary for their functioning in order to provide:
  • prevention, diagnostics, treatment, observation or relief for patients’ condition in case of disease, trauma, disablement or their compensation; 
  • research, replacement or change of structure (anatomy) of organs, tissue or physiological processes; 
  • control of fertilization processes. 
State registration of medical products is carried out on basis of application and respective document package submitted to the State Drug Inspectorate by the applicant liable for manufacturing, safety and efficacy of medical products. The list of document to be attached to the application is specified by the Procedure for state registration of medical equipment and medical products as approved by the Resolution of the CMU dd. 09.11.2004 # 1497. The State Drug Inspectorate shall examine submitted documents within max. 90 days.

In order to conduct necessary expert examinations and testing of medical products the State Drug Inspectorate shall engage expert institutions and give the applicant respective referrals. The applicant shall choose expert institutions taking into account profile of the expert institution and the list comprised and approved by the State Drug Inspectorate. Results of the expert examination conducted by the expert institution shall be stated in a protocol (report, conclusion) which shall be sent to the State Drug Inspectorate or handed over directly to the applicant. Based on motivated conclusion of expert institutions the State Drug Inspectorate shall accept testing of the medical product. It shall be noted that time of such testing shall not be included to the term of expert examination conduction.

Based on consideration of expert examination (testing) report and recommendation of the advisory body in the sphere of state registration the State Drug Inspectorate shall make a decision on registration of or refusal in registration, if conclusion on safety, quality and efficacy of the product is not confirmed. Within 10 days the State Drug Inspectorate shall inform the applicant in writing.

Based on decision on state registration medical products shall be included to the State Register of Medical Equipment and Medical Products kept by the State Drug Inspectorate, and the applicant shall receive a certificate on state registration of a medical product. The certificate can be accompanied annexes with information on modification of medical products and component products.

The certificate is valid for up to 5 years, after expiration of its term import to Ukraine, sale and use of medicinal products is possible only after its re-registration. Application for re-registration of medical products shall be submitted to the State Drug Inspectorate not earlier than 120 and not later than 90 calendar days before the expiration of the certificate validity term. The legislation stipulates that re-registration of medical products is carried out in accordance with the procedure stipulated for state registration.

The re-registration of medical products shall be carried out in case of:
  • change of name and location of the owner (manufacturer, developer), medical products’ presentation; 
  • transfer of rights for manufacturing of medical products to other manufacturer; 
  • changes in manuals for medical products; 
  • changes in requirements of normative documentation as to medical products; 
  • revealing of contra indications and restrictions in use of medical products; 
  • use of new materials contacting with human body during manufacturing of medical products.
Powered by Blogger.