Medical products certification

Medical products are devices, apparatus, equipment, tools, software and materials intended for diagnostic research, treatment of diseases, rehabilitation, etc. According to established laws, certification of medical devices is mandatory and is carried out in the form of a declaration.

Any tools, apparatus, devices, equipment, materials and other products subject to medical use separately or in combination with each other, as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body, conducting medical research, Lenia, substitutions, changes anatomical structure or physiological function of the body, preventing or interrupting pregnancy whose function is realized by pharmacological, immunological, genetic or metabolic effects on the human body.

Certification of medical devices is carried out taking into account all the requirements of the Ministry of Health.

The term “medical equipment” encompasses a very wide range of products, including appliances, supplies, medical furniture, appliances, etc. and intended for diagnostic, rehabilitation, preventive, therapeutic measures and providing care for the disabled and sick. Means that have an immunological, metabolic, genetic, pharmacological effect on the human body do not apply to medical devices.

The structure of health care products and goods subject to certification include:

  • Latex products and adhesives for medical use (surgical gloves, medical glue, diagnostic gloves, etc.)
  • Rubber products for medical use (rubber tubes, etc.)
  • Paper products used in medicine
  • Dressings (surgery materials, gauze, medical cotton wool, napkins, bandages, cotton-gauze products, etc.)
  • Glass containers for medical use (for blood, substitutes, medicines, etc.)
  • Fixing and compression elastic products made of synthetic yarns
  • Protective face shields
  • Medical furniture
  • Prosthetic and orthopedic products
  • Medical instruments, syringes, etc.
  • Medical equipment