An extensive group of medical devices (MDs) includes completely different products that may include different components. In the section devoted to MD, articles about drugs as part of MD have been published more than once (here and here). However, in addition to medicinal substances, various components of animal origin can be included in MD.

1. Product overview

Among the MD, which include components of animal origin, can be identified, for example, bone materials. The main purpose of bone materials is to promote wound healing and bone formation.

Bone materials are of several types: autogenous (obtained from the patient), allogeneic, xenogenic, etc.

The source of allogeneic bone materials is a donor of the same species, i.e. another human. The xenograft is a bone material that is taken from animals. The bones of animals, most often cattle (bulls, horses, pigs), are specially treated and sterilized to ensure maximum biocompatibility.

In addition, there are various membranes designed, for example, for the surgical treatment of periodontal diseases. The membranes used in surgical dentistry are divided into two large groups: non-resorbable and resorbable.

Non-resorbable membranes, as a rule, consist of polymers that must be removed from the tissues after some time.

Resorbable membranes include membranes that contain collagen. So, for example, in the territory of the Russian Federation the “Xenoplast” membrane is registered, the main component of which is the bone tissue of bulls and horses.

When using collagen membranes soft tissue divergence occurs much less frequently than when using non-resorbable membranes. The natural structure of such membranes minimizes the risk of inflammatory reactions. In addition, due to the high flexibility and hydrophilicity, they are much easier to install and fit snugly to the defect.

2. Additional documents required for registration

According to the Order 11n, p. 12, the registration dossier for such medical devices should include information about the “list of materials of animal and (or) human origin, indicating their biocompatibility and safety, selection of sources (donors), sampling, processing, storage and handling of these materials (if any)”

The document to be included in the registration dossier is the Certificate of Safety of Origin of Raw Materials (the name of Certificate can vary), which includes the certificate itself and its annexes. The appendices are the protocols confirming the abovementioned information.

References:

1. Приказ Минздрава России от 19.01.2017 N 11н “Об утверждении требований к содержанию технической и эксплуатационной документации производителя (изготовителя) медицинского изделия” (Зарегистрировано в Минюсте России 10.03.2017 N 45896)
2. Иванов С.Ю., Гажва Ю.В., Мураев А.А., Бонарцев А.П. ИСПОЛЬЗОВАНИЕ МЕМБРАННОЙ ТЕХНИКИ ДЛЯ НАПРАВЛЕННОЙ РЕГЕНЕРАЦИИ КОСТНОЙ ТКАНИ ПРИ ХИРУРГИЧЕСКИХ СТОМАТОЛОГИЧЕСКИХ ВМЕШАТЕЛЬСТВАХ // Современные проблемы науки и образования. – 2012. – № 3.;
3. Kumar P, Vinitha B, Fathima G. Bone grafts in dentistry. Journal of Pharmacy & Bioallied Sciences. 2013;5(Suppl 1):S125-S127. doi:10.4103/0975-7406.113312.