Among the exceptional diversity of medical devices varying in their purpose, mechanism of action, design properties, complexity, technical and functional characteristics, a special category of devices should be singled out: devices containing pharmaceutical drugs.
Any manufacturer intending to obtain state registration for such devices in the Russian Federation will find it useful to learn in advance about certain possible difficulties that may arise in their way.
To clarify the situation, let us discuss the three main questions that come to mind when medical devices containing pharmaceutical drugs are registered.
First question – What medical devices can contain a pharmaceutical drug? Examples of such devices include, but are not limited to, the following:
- Stents (for coronary, renal, popliteal, carotid, and femoral arteries; for paranasal sinuses) with a coating secreting a pharmaceutical drug
- Catheters (peritoneal, ventricular, coronary)
- Material for correcting skin defects (fillers)
- Surgical meshes
- Transdermal patches
- Materials for embolisation of cerebral blood vessels
- Bone cements containing pharmaceutical drugs
- Reagents for in vitro diagnostics
- Condoms with a pharmaceutical drug
Second question – Where are the requirements stated for preparing documents for state registration of medical devices containing pharmaceutical drugs?
Three main regulatory documents can be singled out that govern registration of such devices.
- Order of the Ministry of Health of the Russian Federation No 2n “On the Approval of the Procedure for Assessing Conformance of Medical Devices in the Form of Technical Tests, Toxicological Research, and Clinical Trials for the Purpose of State Registration of Medical Devices,” dated 9 January 2014
- Order of the Ministry of Health of the Russian Federation No 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,” dated 19 January 2017
- Federal Law of the Russian Federation No 61-FZ “On the Circulation of Pharmaceutical Drugs,” dated 12 April 2010
Third question – What information will be necessary for state registration of medical devices containing pharmaceutical drugs?
As tests are conducted to ascertain the quality, effectiveness, and safety of a medical device containing pharmaceutical drugs and/or substances, the manufacturer must submit proof that such the effect of such components on the human system are safe. Such proof will be information about the pharmaceutical drugs or the number of the pharmacopoeia article (if available).
Thus technical and user documentation provided by the manufacturer must contain information in accordance with the state register of pharmaceutical drugs for medical use about the following contained in the medical device:
-The pharmaceutical drug, including the following information:
1) Name of the pharmaceutical drug for medical use (international non-proprietary, or generic, or chemical and trade),
2) Name of the manufacturer of the pharmaceutical drug for medical use,
3) Date and number of the registration certificate of the pharmaceutical drug for medical use;
-Or the pharmaceutical substance, including the following information:
1) Name of the pharmaceutical substance (international non-proprietary, or generic, or chemical and trade),
2) Name of the manufacturer of the pharmaceutical substance
3) Date and number of the entry in the state register of pharmaceutical drugs for medical use;
Attention should be paid to the fact that the declared dosage form must correspond to the medical device, otherwise the manufacturer’s technical documentation must contain information about the technologies used by the manufacturer to prepare the formulation from the declared finished dosage form.
Important: The following documents may also be required for registration:
- A certificate of conformance to good manufacturing practices (GMP) for the manufacturer of the active pharmaceutical substance (legalised)
- A Russian GMP conformance certificate issued by the Ministry of Industry and Trade
To summarise the above, as medical devices containing pharmaceutical drugs are registered difficulties arise in cases when the pharmaceutical drug and/or substance included in the medical device has not yet been registered in the Russian Federation. In this case, the registration procedure may be significantly delayed: the pharmaceutical drug will first have to be registered in the Russian Federation.