medical devices registration in the Federal Service for Surveillance in Healthcare register-医疗器械的概念涵盖范围广泛的产品——从设备、耗材到医用家具。 医用产品根据风险程度和功能分类——能量来源、与人体相互作用的方式等。为了在俄罗斯联邦和关税同盟的医疗机构中合法使用，所有医疗 设备必须通过联邦医疗保健监督服务登记处的医疗器械注册。
RUSSIAN MEDICAL DEVICE REGISTRATION
Overview
Groups of medical products
The list of medical products and goods to be declared
Required documents
Price calculation
The concept of medical devices covers a wide range of products – from equipment, consumables to medical furniture. Products for medical purposes are divided into classes according to the degree of risk and function – the source of energy, the way of interaction with the human body, etc. For their legal use in medical institutions of the Russian Federation and Customs Union, all medical devices must pass the registration in the Federal Service for Surveillance in Healthcare register.
There is a Global Medical Device Nomenclature.
Medical products can be divided into 2 groups:
1.By their degree of security:
Class
Degree of risk
1 class
low risk
2a class
average risk
2b class
increased risk
3 class
high risk
2.By function (energy source, vital functions, the way of interaction with the human body, the duration of use, invasiveness).
Software used for medical devices gets the same class as medical devices for which it is intended and also applies to medical devices. All medical devices must be registered in the State Register of Medical Devices of Roszdravnadzor for their legitimate use in health facilities of the Russian Federation. According to the list of products subject to mandatory declaration in the GOST R system medical equipment must have a declaration of conformity.
For the largest number of medical goods, you need to issue a declaration of conformity, but there are also medical products for which a certificate of conformity is required in the GOST R system. You can find out what a medical product is subject to certification or declaration in the list of products subject to certification and declaration in the GOST R system.
he list of medical products and goods to be declared includes:
Latex products and adhesives for medical purposes (surgical gloves, medical glue, diagnostic gloves, etc.)
Rubber products for medical use (rubber tubes, etc.)
Paper goods used in medicine
Means for dressing (materials for surgery, gauze, cotton wool medical, napkins, bandages, cotton-gauze products, etc.)
Medical glass containers (for blood, substitutes, medicines, etc.)
Fixing and compression elastic products made of synthetic threads
Facial protective shields
Medical furniture
Medicines passed the state registration
Medicines
Drugs and vitamins for humans and animals
Prosthetic and orthopedic products
Animal vaccine sera
Medical instruments, syringes, etc.
Medical equipment
Thus, for the implementation of medical equipment and products within the framework of the current legislation it is necessary to go through the procedure of registering medical products in the Federal Service of Roszdravnadzor and obtain a Registration Certificate. To do this, you must: apply for registration, provide samples of medical devices and the necessary documents. Roszdravnadzor performs examination of documents, as well as testing of samples and toxicological, biomedical and sanitary-hygienic studies. After these checks, in the event of a positive result, Roszdravnadzor shall enter the medical device in the State Registry and issue a Certificate of Registration.
