Toxicological testing

Performance of toxicological testing on medical products

One of the mandatory stages of the state-registration procedure for medical products, as envisioned by RF Governmental Resolution No. 1416 dated 27 December 2012, is the performance of toxicological testing. Such testing is performed back at the stage involving the preparation and compilation of the registration dossier, that is – prior to submission of the application for state registration to the responsible oversight agency, in this case: Roszdravnadzor. This requirement is predicated on the fact that unsatisfactory toxicological results automatically make the product ineligible for state registration, insofar as it could turn out to be hazardous to consumers.

Toxicological testing

The main purpose of organizing such testing is to evaluate the nature of the product’s impact on the human body in terms of physical-chemical and sanitary-chemical parameters, as well as according to certain biological criteria whose impact is tested under in vitro and in vivo conditions. Products developed for one-time use (disposable products) must also pass a sterility test. Products whose use entails direct contact with the blood and its components must undergo an evaluation according to their pyrogenicity and hemocompatability parameters. The selection of samples to undergo testing is conducted in accordance with the requirements of the interstate standard GOST 31214-2016. If the product entails its use with other accessories or devices, they must also be sent for testing.

The performance of toxicological testing is mandatory for all types of medical products, irrespective of their potential-risk class, if they or the implements used in the course of their use:

• come into contact with the skin, mucous membranes or other surfaces of the human body;
• are temporarily inserted into the body to perform the prophylactic, diagnostic or therapeutic functions envisioned by their intended purpose; entail permanent implantation into the human body to correct the functioning of certain joints, tissues or organs.

Organization of toxicological testing

Only accredited medical organizations are entitled to conduct toxicological testing; that said, the specific area of their accreditation must coincide with the scope of application of the product slated for state registration. The performance of toxicological testing at such organizations must be undertaken in accordance with the requirements of the Russian national standard GOST R 52770-2016. This is the regulation that forms the basis for developing the testing program, which is agreed upon with the management of the company submitting the registration application. Over the course of the testing, the following parameters are evaluated with respect to each product:

• compliance of the product itself and the accompanying manufacturer’s documentation with the requirements of the applicable standards and technical regulations;
• conformance of the product with the information provided in the manufacturer’s operational and technical documentation, and the completeness of such information;
• relevance of the proposed methods for testing the product;
• safety of the medical product’s application, provided its use for the specific purpose established by the manufacturer.

Pursuant to Clause 28 of RF Ministry of Health Order No. 2, all actions taken within the scope of toxicological-testing procedures must be completed within a period of no more than 30 business days. This period begins running from the moment of the applicant’s presentation of the required samples of the product being tested. In exceptional cases, by agreement with the applicant, it may be extended by another 20 business days. The testing results are drawn up as reports per the established form. These documents must subsequently be included as part of the registration dossier submitted to Roszdravnadzor. The Center for the Registration of Medical Products offers services involving the turnkey organization of toxicological testing. We conduct the toxicological testing of medical products in Moscow, St. Petersburg and other major cities using the facilities of accredited laboratories. Once our work has been completed, you receive a full set of documents ready for inclusion in the registration dossier.