Medical products registration

Medical products refer to a set of medical equipment pieces used separately or together. It includes all the supplementary pieces necessary for the operation of the devices, as well as medical software. Medical products include accessories used for:

• preventive treatment;
• comprehensive treatment;
• disease diagnostics;
• patient rehabilitation;
• research activity;
• maintaining and substituting body functions;
• actions aimed at abortion.

Registration of medical products is obligatory for devices and medications; it allows their further operation and use by healthcare providers.The registration certificates are issued by the Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor). Failure to obtain a registration certificate prevents legal use of any medications and treatment devices. Healthcare centres that have violated the rule are subject to criminal prosecution.

Successful issuing of the certificate is conditioned by thorough document preparation. The applicant can prepare the documents on their own, however this is rather complicated.

Universalpravo offers its clients assistance in the registration procedure assured by highly-skilled experts. Trusting your documents to a professional speeds up and simplifies the complicated process of drawing a file of documents for medical products.

Without the registration certificate, the medical product cannot be sold or legally used on the territory of Russia, it is considered counterfeit and, in accordance with the Federal Law No. 532-FZ dated 31 December, 2014

“On amending specific legislative acts of the Russian Federation with the aim of counteracting the sales of adulterated, counterfeit, defective or unregistered medications, medical products and adulterated biologically active additive” is subject to criminal liability.

Stages of medical products registration

The process of registration consists of 5 consecutive steps:

1. Tests of medical products. Includes technical check of the products functions and chemical analysis of its materials for compliance with the quality and safety standards.
2. Preparing documents required for the application: primary application, test results protocol, and supporting documents.
3. Check of the papers submitted. Carried out by Expert examination centre staff.
4. Clinical trials.
5. Expert check of the product compliance with the safety, operability and durability standards.

The exact list of documents required to start the procedure is regularly updated. ur company is constantly in touch with the Roszdravnadzor experts, which allows us to possess up-to-date information on the amendments to the list of documents.

State registration of medical products is not required if:

It is not necessary to register medications and accessories that were manufactured on a personal order. The only condition is that the product use is restricted to the person who ordered it.

Registration time and cost

Standard period required for completing all procedures is 50 days. However, this estimate does not account for the duration of expert tests or the time required to prepare all the documents. Consequently, registration time can be estimated at around 5 months. The final time depends on the type of product

The cost of the entire procedure is defined by two factors: state duty for services provided and cost of tests.

Amount of state duty

State registration of medical products — RUB 7,000

Medical product quality, efficiency and safety expert test (depending on the class of potential hazard):

• class 1 — RUB 45,000;
• class 2 — RUB 65,000;
• class 2b — RUB 85,000;
• class 3 — RUB 115,000.

Minimal cost of final expert test is defined based on the class of potential hazard of product use: RUB 80,000 or more.

Our services for medical products registration

Universalpravo provide the full range of services related to medical products registration. We offer:

• examination and correction of a ready supporting documents file;
• drawing of a product file;
• assistance during clinical trials;
• drawing of documents required to start the procedure;
• consultations at any stage of the check.

 

Besides, Universalpravo assists you in drawing and executing necessary documents and protocols, and in obtaining a clinical opinion on the medical product safety.

Do not hesitate to come to us for a consultation, a specific service or the full service package, from documents preparation to obtaining the registration certificate.

Process of state registration of medical products

 

1. Examination and analysis of the submitted documents for the product.
2. Assessing the completeness of the documents package and the correctness of documents required for state registration of medical products.
3. Primary assessment of the medical product purpose.
4. Defining the type of medical product in accordance with nomenclature.
5. Defining the class of potential hazard of medical product in accordance with nomenclature.
6. Defining the code in accordance with the All-Russian Classifier of products for medical use (from January, 2017, OKPD-2).
7. Consultation regarding the drawing of technical and operation documents based on the data provided by the manufacturer, in accordance with the legal requirements.
8. Preparation and submission of documents for state registration, application endorsement, follow-up of the registration process stages (support during registration).
9. Preparation of a package of documents for technical and toxicity tests (support during tests).
10. Preparation of a package of documents for clinical trials (support during trials).

 

Part 4 of Article 38 of the Federal Law No. 323-FZ dated 21 November, 2011 “On fundamental healthcare principles for Russian citizens” specifies determined that only sale of medical products that have been registered following the procedure adopted by the Government of Russia or by a federal executive agency authorized by the Government of Russia, is allowed on the territory of the Russian Federation.