About pharmaceutical agents in the composition of medical devices and registration difficulties
In March 2017, Order 11n “On the Approval of the Requirements Imposed on the Contents of the Technical and User Documentation Provided by the Manufacturer (Maker) of a Medical Device,” came into force. This document specifies the requirements to the technical and user documentation for medical devices including those which contain drugs. However the interpretation of these requirements by Roszdravnadzor (RZN) made registration of such devices much more difficult (in Russian – here, на русском – здесь).
In September 2017, 38 manufacturers and distributors of medical devices presented a petition to Roszdravnadzor and the Ministry of Health with the hope to clarify the situation. However, since that time there haven’t been any changes.
So, what devices are we referring to?
Nowadays medical devices containing drugs are widely used in such fields of medicine as: dentistry, aesthetic medicine, cardiology, ophthalmology, traumatology, etc.
The devices include the following groups:
- Wound dressings
- Drug eluting stents
- Ophthalmological solutions
- Material for correcting skin defects
- Bone cements containing pharmaceutical drugs, etc.
See more about groups and registration aspects: https://beawire.com/2017/09/29/aspects-of-registration-of-medical-devices-containing-pharmaceutical-drugs/
The composition of above listed groups can include different pharmacological agents. For example, wound dressings can contain antibiotics (Dioxydine), topical anaesthetics (Lidocaine), vasoprotectives (Rutin), vitamins (Ascorbic acid), antiseptics (Povidonum-Iodum+Kalii iodidum) In the composition of patches we can find antiseptics (Chlorhexidine digluconate), antibiotics (Furacilin, Chloramphenicol).
In cardiology drug eluting stents are widely used. This type of stents contains drugs coated by a polymer to prevent fast out washing. Among the pharmaceutical agents there can be specified immunosupressors with antiproliferative effect (Sirolimus, Everolimus) allowing decreasing the frequency of occurring restenosis. Also antitumor (Paclitaxel) and antithrombotic (Heparin) agents are applied.
Ophthalmological solutions, for example for lens сleaning, contain antioxidants (Fumaric acid, Sodium fumarate) along with Hyaluronic acid, preventing drying out of lenses.
Some fillers, which are widely used in aesthetic medicine, contain not only hyaluronic acid but topical anaesthetics (Lidocaine).
Now it can be seen that there are a lot of life-saving medical devices, containing pharmaceutical agents. The difficulties in their registration can lead to negative consequences in Russian healthcare system.