Registration of medical devices and medicines

Due to our waste experience and deep knowledge of procedire, registration goes quickly and easily.

Registration of medicines

Registration of medicinal products is carried out in several stages, including preparatory measures, conducting research and submitting documentation to the competent authorities for making a decision on issuing a registration certificate.

Registration takes a fairly long period of time. The preparetion phase lasts about 4-7 months. Clinical trials last from 2 weeks. A certificate is issued 9-18 months after the submission of the appropriate package of documents (duration depends on which type of drug is registered and is less for generics and larger for original medicines). The procedure is described in detail in the Federal Law that regulates the circulation of medicines (No. 61-F3, Article 13), which came into force on September 1, 2010.

An important stage in the new procedure for drug registration is the conduct of mandatory clinical trials in the territory of the Russian Federation. For medicines permitted for medical use in the Russian Federation for more than 20 years, an exception has been made, and they should not be subjected to additional tests. The UNEX Expert Union is a team of experts of the highest class.

Thanks to our extensive experience and deep knowledge of the nuances of the procedure, the registration of medications is quick and easy. We take care of the whole process of registration and maintenance of documents, up to the delivery of the received registration certificate of the drug to the customer. Full compliance with all rules and regulations allows you to avoid the need to re-apply and a new long waiting period.

Preparation of medicines for registration includes a number of stages during which there is practically no interaction between the expert organization and the applicant.  The entire procedure takes place before the registration examination, which includes:

• Documentation permitting clinical study of drugs;
• Quality of the test drug;
• The ratio of the likely benefit and risk of the drug.

Pre-registration training The first step towards successful registration of the drug is the consultation of the applicant, during which the experts provide all the information necessary for the client, with his participation, make up and approve the plan for subsequent registration. If necessary, the Expert Union UNEX undertakes preliminary (additional) tests of medicinal products subject to registration. After passing all the necessary tests, experts of the UNEX Union are preparing a file designed to provide the registration committee. In the course of preparation, development of NDs takes place (if medicines are produced by foreign companies), editing and translation of documentation. Conducting clinical trials precedes the preparation of permits. The documents are accompanied by the employees of the Union until the permission of the representative of the Ethics Committee is obtained. After obtaining permission, filing an application in electronic form and submitting the dossier, including the entire package of documents, to the Ministry of Health and Social Development, the stage of clinical trials of the drug begins. The steps that take him take from 4 to 7 months. And the clinical trials themselves last from 2 weeks or more.

UNEX union of experts provides full support of the process, including the importation of medicines and their customs clearance, which is necessary before carrying out the research. Employees of the union ensure timely selection of voluntary test participants, full compliance with the research protocol and sampling of biological samples. In the framework of the study, pharmacokinetic characteristics are determined and statistical calculation is performed. Reports containing the results of the study are formed according to international standards. After the end of the study, all primary data is transferred to the customer. The process of registration of medicines UNEX experts support all stages of the procedure for registration of medicines, including the preparation and provision of additional documents to the Expert Organization. The stage of obtaining a certificate of registration lasts from 9 to 12 months with the registration of generic drugs and from 12 to 18 months, in case the original preparations are registered. The received registration certificate is transferred to the customer. Expert Union UNEX allows you to save energy, time and money, speeding up and simplifying the process of registration of drugs. Cooperation with professionals allows them to delegate to them all concerns about the preparation of documentation and ensuring the successful completion of the registration procedure, having received a ready registration certificate of the drug in the shortest possible time.

Registration of medical devices

UNEX union of experts provides services for the registration and certification of medical equipment. In addition, experts conduct an examination of products used for medical purposes. All this happens at a high-quality level, at an acceptable cost and in a short time.

According to the regulatory legal acts of the Russian Federation, the use of medical devices without a registration document issued by Roszdravnadzor is illegal.

The price of such services as the registration of medical devices in the company UNEX is calculated exclusively individually. It depends on the type of instruments, their class and the degree of risk in use. The experience of the specialists of the organization will help to issue the registration certificate of Roszdravnadzor quickly and absolutely legitimately.

Required list of documents for the registration

A decree of the Government of the Russian Federation establishes a specific list of documents required to obtain a registration certificate for medical devices:

• A copy of the confirmation of authority from the representative of the equipment manufacturer;
• Information on regulatory documents on medical devices;
• A package of technical documents relating to specific medical devices;
• Instruction on the use of the product and all data concerning the features of its operation;
• Photos of devices with all the additional parts (the size of the images should be not less than 18 cm by 24 cm);
• Confirmation of successful technical tests, by means of which the quality and performance of medical devices are checked;
• If the device is in direct contact with the human body, a certificate of the permissible toxicological norms for the composition of the facility is necessary;
• To get the registration certificate of the Ministry of Health for measuring devices is possible only if there are documents on the passage of the corresponding tests, the results of which coincide with the established indicators of the Ministry of Health of the Russian Federation;
• An inventory of the entire package of documents submitted.

Changes to the registration card

Our company provides not only such services as the registration of medical equipment, but also the modification of data in an already issued document. This service is typical for several cases, which concern the registration of a legal entity, namely:

• Changing the address of the legal entity;
• Registration of a new name or partial modification of an old one;
• Reorganization of the company.

In addition, the registration certificate of Roszdravnadzor should be redone in the case of a new product name, if it has not changed its functions and quality characteristics. The same applies to the change in the place of production of machinery. In all the above cases, the registration card is not re-entered, but the updated data is simply added to it.

For this service, the client must provide a certain package of documents, without which it is impossible to carry out the procedure for changing the registration document lawfully. This list includes:

• A statement on the need to make changes to a specific sample (indicating specific updated information and confirming that the medical product retained its original characteristics to the fullest extent);
• A copy of the confirmation of the authority of the representative of the manufacturer;
• Number of the registration certificate;
• An inventory of all collected documents.

If the customer needs to specify new data on the name of the legal entity or its address, all such documents are accompanied by confirmation of such changes. When the procedure relates to changing the product name, the package is supplemented with the following information:

• Data on all regulatory documents for the specified equipment;
• Updated technical data of the medical device approved with a new name;
• Instruction for the use of the product, registered with the updated name;
• Photos of medical equipment and all components used with it, at least 18 cm by 28 cm.

Services of the UNEX Expert Center

Registration of medical products in our company occurs with minimal material and time costs for the client. The team of professionals conducts the necessary amount of work on the preparation and preparation of the entire package of documents. By contacting the UNEX Expert Center, you can count on the following quality services:

• A full analysis of the medical equipment provided for registration;
• Primary technical analysis of the performance characteristics of the device, depending on its composition and direct functions;
• Determination of the type of product and the level of potential risk when using medical equipment in accordance with the legislation of the Russian Federation;
• Code assignment according to the All-Russian classification of medical products;
• Consultation of the client on the preparation of the necessary operational documentation and instructions for using the product;
• Preparation for clinical and toxicological testing of the facility;
• Final analysis of the correctness of the collected documentation for obtaining the registration certificate of the Ministry of Health;
• Accompaniment of the documentation package at all stages of the registration process;
• Transfer to the client a registration certificate of a medical product.
• Working with UNEX, each client receives a guarantee in the registration of the registration document. The procedure for registration of medical equipment is compulsory and rather complicated.

The expert center has a lot of experience in this activity, which is confirmed by a lot of certificates. We provide services for the examination of medical equipment in a laboratory accredited by the state body of the Ministry of Health. Our employees accompany the entire process of registration of the registration certificate: from the beginning of collection of documents to the issuance of a ready certificate of Roszdravnadzor.

The use of medical equipment is a big responsibility, as the procedure directly affects people's health. Therefore, the rigid position of state authorities in terms of registration of medical equipment is absolutely understandable. Using the services of the UNEX Expert Center, you can quickly and easily go through this serious process with a minimum amount of costs. Great experience and competence in the legislation of the Russian Federation allows UNEX to receive exceptionally positive feedback about their work, which are the best proof of the quality of services. Many companies apply to us who have been denied registration of medical products because of an incorrectly prepared documentation package. Therefore, we recommend that you immediately turn to UNEX specialists and be sure of the result.