Certification of medical equipment is an obligatory procedure in Russia, with the help of which it is possible to confirm the compliance of products of this category with the GOST R standards. However, for the implementation of services of this kind, it is necessary to possess the appropriate knowledge and skills.
“Quality” LLC is engaged in professional activities related to the certification of medical equipment. For many years, certification and declaration of medical products are among our priority services, and we make every effort to ensure the professional quality of events and provide each customer with favorable conditions for cooperation.
Our company employs specialists who are ready in the shortest possible time to make the necessary laboratory tests and correctly execute all the accompanying documents.
Certification of medical products performed by our employees has several advantages. These include:
- The minimum period for testing and drafting the certificate;
- Registration and certification of medical products is carried out in our company at loyal prices;
- We are ready to provide detailed advice on all issues;
- The possibility of obtaining reliable and accurate results.
“Quality” LLC has competent employees who have solid experience in collecting information for certification purposes and can provide competent legal support. We will help you quickly and easily obtain permits confirming the safety and quality of medical equipment sold. Working with us, you can rely on the fact that certification of medical products will be performed at a decent level and within strictly specified time limits.
Certification of medical devices in the Russian Federation
Medical equipment is products intended for diagnostic, prophylactic and therapeutic purposes.
Certification of medical devices in Russia is considered mandatory for all categories of goods. In this case, the result of this procedure is to obtain a declaration of conformity. A separate certificate of conformity is issued for protective glasses, which can have a direct impact on the state of the body.
Certification of medical equipment in Russia is aimed at obtaining a declaration – a document confirming the quality of the sample of goods used. Below are medical devices that are subject to mandatory certification:
- Instrumentation: piercing, cutting and other devices;
- Trauma devices;
- Equipment for the implementation of anesthesia, measuring mechanisms, medical devices;
- Diagnostic devices;
- Medical kits;
- Mechanisms capable of replacing organs;
- Devices for sterilization and disinfection;
- Glass packaging for medical purposes;
- Medical equipment for chambers and offices;
- Sanitary and hygiene equipment;
- Dental equipment;
- Instruments for otorhinolaryngological appointment, etc.
Mandatory certification of medical devices can be carried out along with a voluntary procedure. However, certification of medical equipment performed voluntarily involves obtaining a permit on a blue form. Such a permissive document causes greater endorsement by end users.
In order to obtain the above documents, it is advisable to contact a certification authority and declare medical devices for help. These institutions must have a special accreditation certificate, which allows certification activities in Russia.
What documents are required to provide for the certification of medical equipment:
- OGRN (Primary State Registration Number), TIN (Taxpayer Identification Number), contract for the supply of medical equipment, the company’s charter, the requisites of the applicant company: if the products are manufactured by a foreign manufacturer;
- Details of the applicant company, description of medical products: if the goods are produced in foreign countries and supplied on a contract basis;
- The company’s charter, OGRN, documents with technical data, TIN, certificate of ownership, details of the applicant organization: if the equipment is manufactured by a Russian manufacturer.
It is important to consider that, according to the existing legislation of the Russian Federation, the declaration of conformity is executed only on products of a Russian manufacturer. If medical equipment is supplied from a foreign country, a declaration is issued to the importing company operating in Russia.
Дополнительные условия, необходимые к исполнению в рамках сертификации медицинских изделий
As you know, all medical devices in one way or another affect the state of the body of citizens. That is why for this category of goods are carried out ancillary activities aimed at ensuring security.
The mandatory requirement for execution in the manufacture and distribution of medical equipment in the Russian Federation is the passage of the registration procedure in the authorized structure. If the registration of medical products in Roszdravnadzor (federal service on surveillance in healthcare) was not carried out, the importation of the above equipment into the territory of our state is considered illegal.
Thus, another important document confirming the safety of imported products is considered a certificate of state registration. As mentioned above, it is obtained for all types of medical products in the Federal Service for Supervision of Consumer Rights Protection and Human Welfare. If the applicant does not have such a document, certification of medical equipment is not feasible in our country.
How is medical device certification performed?
A prerequisite under which certification of medical devices is carried out is the passage of appropriate laboratory tests. This means that it is possible to obtain a certificate of conformity only after receiving the test result provided for each specific type of goods. After the test is completed, a special protocol is presented that entitles you to receive a certificate. To conduct such research can only accredited laboratory.
Our center of certification of medical devices provides qualified support in the field of laboratory research, as well as the issuance of declarations and certificates. We work with medical equipment of Russian and foreign manufacture. At the same time, you can be sure that the certification of medical products will be carried out with the participation of competent and responsible professionals.