Features of state registration process for different types of medical products

The whole range of medical devices can be divided into several groups that have their own nuances and special features when preparing documentation within the procedure of the state registration.

It is significant that one medical device can simultaneously belong to several groups. In this case, the characteristics of each group should be considered.

 

  • Implantable Medical Devices (implants).

These devices are intended to be totally or partially introduced into the human body, to replace any epithelial surface or eye surface surgically for a period of not less than 30 days, which can be removed only through medical or surgical intervention.

Examples of such devices are: intravascular implants, surgical/cosmetological suture materials, osteosynthesis implants/bone replacement materials, dental implants, materials for the reconstruction of tissue/skin defects, etc.

Key features of this group are:

  1. High risk class (usually 2b or 3),
  2. Strict requirements for the biocompatibility of materials and products of possible wear and tear,
  3. Requirements included in the relevant standards for manufacture of certain types of implants.

 

  • Active medical devices.

These are devices relying for their functioning on a source of electrical energy or any other source of power other than that generated by the human body or gravity with the exception of the medical devices intended to transmit energy, substances or other elements between an active medical device and the patient without any significant changes.

Examples of such devices are: Diagnostic devices (electrocardiographs, ultrasound systems, tomography systems), therapeutic instruments, general hospital products (lighting products, sterilisers), etc.

Key features of this group are:

  1. Requirements and tests for electromagnetic compatibility,
  2. Requirements of the standards for medical electrical equipment,
  3. As a rule, a complex structure of a medical device.

 

  • Medical devices for in vitro diagnostics.

These are the devices that are a reagent, a reagent-based product, a calibrator, a control material, a set of medical instruments, an instrument, an apparatus, equipment or a system used alone or in combination and designed by the manufacturer for in vitro use (under artificial conditions — “in a test tube”) for investigation of the samples including blood and tissue samples taken from the human body, solely or mainly for the purpose of obtaining information on:

  • a physiological or pathological condition,
  • congenital anomaly,
  • determining safety and compatibility with potential recipients,
  • monitoring therapeutic interventions.

Examples of such devices are: analysers, reagents/sets for determination of analytes of in vitro diagnostics (IVD), vessels/containers for IVD samples, etc. More information about IVD by link.

 Key features of this group are:

  1. Presence of a large number of required metrological, functional characteristics and regulated requirements for the components (reagents) included in the devices, indicating the composition values (without disclosing a commercial secret), qualification, grade or brand, as well as technical and regulatory documentation, in accordance with which they are manufactured,
  2. Presence of risks when using or marketing the device including special protective measures in respect of the device substances of human or animal origin, taking into account their potential infectious nature.

 

  • Medical devices containing a medicinal product.

Examples of such devices are: drug-eluting stents (for coronary, renal, popliteal, carotid, femoral arteries, for paranasal sinuses); materials for embolisation of cerebral vessels; bone cements containing medicinal products; drug-coated catheters; material for correction of skin defects, etc.).

Key features of this group are:

  1. The medicinal product included into a medical device must be registered on the territory of the Russian Federation,
  2. The declared dosage form must correspond to the medical device.

More details – here (Sept 2017).

 

  • Sterile single-use devices.

This group of devices is quite comprehensive and includes the following examples of the devices:

Injection syringes, surgical dressings, systems of delivery of implantable intravascular devices (catheters, guidewires), anaesthetic and respiratory devices, disposable surgical instruments.

Key features of this group are:

  1. Specific requirements for packaging of devices (packaging process validation),
  2. Requirements for sterilisation of the device (sterilisation process validation).

 

  • Measuring medical devices.

Measuring medical devices required special additional testing during registration process. How to know that medical device is measuring medical device – find answer here.