Technical testing

The guaranteed quality and safety of any medical product, provided its use according to the specific purpose envisioned by the manufacturer, is a critical requirement imposed by applicable legislation. The product manufacturer must demonstrate the satisfaction of this condition in order to obtain a certificate of state registration for the product. The method for demonstrating its satisfaction, pursuant to RF Governmental Regulation No. 1416 dated 27 December 2012, governing the state-registration procedure for medical products, is technical testing.

Technical testing of medical products for the purposes of registration

The procedure for the performance of technical testing is established by a separate regulation – RF Ministry of Health Order No. 2n dated 9 January 2014. Pursuant to Clause 13 of this regulation, the purpose of technical testing is to establish the following:

• compliance of the product itself and its accompanying documentation to the applicable standards, technical regulations and other legislatively-established requirements;
• quality of the product and its safety when used according to the manufacturer’s instructions.
• conformance of the product to the parameters set forth in the manufacturer’s operational or technical documentation, as well as the completeness of such information;
• relevant methods for the performance of product testing;
• suitability of the operational documentation developed by the manufacturer to the proper use of the product according to its intended purpose;

Only authorized organizations satisfying the criteria set forth in Resolution No. 28 dated 12 February 2016 by the Council of the EEC are entitled to conduct technical testing on medical products. Accredited laboratories for the technical testing of medical products are included on a separate list posted publicly on the official portal of the state department responsible for the state registration of medical products. Pursuant to applicable legislation, this department is Roszdravnadzor.

Organization of technical testing

For all types of medical products, irrespective of the class of the potential risk associated with their use, the performance of technical testing is undertaken back at the stage of compilation of the respective registration dossier, that is – prior to submission of the application for state registration to Roszdravnadzor. This procedure is conducted in accordance with the respective program, which the head of an accredited organization compiles in conjunction with the company acting as the applicant within the scope of the product’s state registration. Pursuant to Clause 10 of Ministry of Health Order No. 2, the period for its completion must total no more than 30 business days from the date of presentation of the required samples. In exceptional cases, it may be extended by another 20 business days.

In most situations, technical testing is organized in the form of testing in accredited-laboratory conditions, which makes it possible to credibly evaluate the product’s quality and safety by recreating the process of its use according to its intended purpose. In certain cases, however, RF Ministry of Health Order No. 2 allows the procedure to be conducted in the form of an analysis of the data contained in the professional literature, documentation on the conditions of the product’s manufacture and reports on previously-completed testing. This is permitted for medical products whose installation and startup requires the following:

• existence of a license or other permit;
• creation of special usage conditions;
• erection of special structures or buildings;
• training of specialists who will be responsible for their operation.

If the data yielded from technical testing in the form of informational evaluation and analysis fail to confirm the product’s qualitative parameters, it is scheduled for standard testing. In all situations, the results of technical testing are drawn up as reports per the established form and included in the respective set of documents. At the Center for the Registration of Medical Products, you can order a service for the turnkey organization of technical testing. Our experts will handle all stages of the procedure, including development of the testing program, organization of the required type of testing using the facilities of accredited laboratories, and the compilation of reporting per the established form. Our center’s experts have intimate knowledge of applicable legislation and are meticulous in their drafting of the required documentation, so your registration dossier won’t prompt questions on the part of the oversight agency’s representatives.