What is a registration certificate for an apartment?

What are medical devices and why register them?

According to Article 38 of Federal Law No. 323-FZ, dedicated to the protection of the health of Russian citizens, medical products are any goods used to achieve medical goals, including diagnosis, treatment, rehabilitation of patients, etc.
The same article requires that medical products circulating in our country have a valid certificate. Manufacturers have no right to sell goods that have not received a registration certificate. What medical products receive marketing authorizations?

Registration algorithm and risk classes

The general rules describing how to obtain a registration certificate from Roszdravnadzor are given in Government Decree No. 1416 of December 27, 2012. The state registration algorithm differs depending on the class of potential risk. The procedure for classifying medical products is fixed in the Order of the Ministry of Health dated June 6, 2012 No. 4n. All products in this category are divided into four classes:

• 1 – low risk level;
• 2a – average risk level;
• 2b – increased level of risk;
• 2 – high level of risk.

General procedure

The standard procedure according to which medical registration of a product is carried out is described in Resolution No. 1416. It applies to most types of medical products, except for those for which simplified rules apply, providing for obtaining a marketing authorization under an accelerated scheme. The registration procedure is the same throughout Russia - from Moscow to Vladivostok.

Simplified registration procedure

In connection with the spread of coronavirus infection, the Government has adopted two new regulations for manufacturers. They provide for obtaining a registration certificate for medical products in a simplified manner according to one of the following schemes:

• PP dated March 18, 2021 No. 299, applies to 36 products of risk class 1 and allows you to obtain a temporary registration certificate valid for 150 days with a minimum package of documents. During this time, the applicant should organize the missing tests and submit the package to Roszdavnadzor in order to receive an unlimited registration certificate;
• PP No. 430 dated April 3, 2021 is valid for 363 popular medical products, which undergo mandatory testing according to a simplified scheme developed by an expert organization.

Legal documents

The transfer of ownership of an apartment, garage, house, land plot and any other real estate object is subject to state registration (Article 551 of the Civil Code of the Russian Federation).
The title documents for the apartment have undergone changes over the past few years, starting in mid-2021. The location of the real estate object in the personal possession of the owner was documented using:

1. Certificates of state registration of ownership of the apartment. The official cancellation of the standard pink form occurred on July 15, 2016, raising the questions: which form is the legal successor and what does the document on ownership of the apartment look like from that date? Extracts provided from Rosreestr and the cadastral chamber could be obtained in parallel during the validity period of the certificates, but they carried background information and served as an appendix to the main document on the ownership of the apartment.
2. Extracts from the Unified State Register. After the certificate was cancelled, the standard form, printed on white paper, became the only document - the basis of ownership of an apartment or other property.
3. Extracts from the Unified State Register of Real Estate. The combination of the cadastral certificate and the above form from the Unified State Register has been in effect since 01/01/2017 thanks to the innovations introduced by Law No. 218-FZ of 07/13/2015. Confirmation of real estate ownership is carried out on the basis of a newly created and approved form.

Documents confirming the ownership of an apartment issued before July 15, 2016 continue to be valid, however, to carry out legally significant transactions, an extract from the Unified State Register is required. The validity period of the certificate is not limited, but to confirm property rights, the form should be updated before the transaction in order to exclude the transfer of housing to third parties or the imposition of encumbrances for the period that has passed since the receipt of the previous form.

The time interval for “trust” in the extract is one month from the date of actual receipt; the certificate does not contain an official validity period. Replacing title documents for an apartment and other real estate does not entail changes in the procedure for completing transactions, but only confirms the identity of the owner.

Types of medical devices for registration

The general list of products for which registration of a medical device with Roszdravnadzor is required is given in Order of the Ministry of Health No. 4n. It contains 19 product categories, which are combined into the following large groups.

Amendments have been made to the Decree of the Government of the Russian Federation of December 27, 2012 N 1416 “On approval of the Rules for state registration of medical devices.” From December 5, 2021, its provisions also apply to software that is a medical device, including software using artificial intelligence technologies.

Receipt procedure

An applicant registering a product should prepare to go through two main stages:

• preparatory, within which the applicant carries out the necessary procedures to prove the quality and safety of the product, and draws up the necessary documents;
• the main one, when specialists from Roszdravnadzor and authorized organizations assess the characteristics of the product and register it in accordance with the law with the issuance of a registration certificate.

Stages

The list of main stages of state registration looks like this:

• conducting tests organized by the applicant, compiling a dossier, submitting it to Roszdravnadzor;
• analysis of documents, appointment and conduct of the first stage of examination, during which the data presented as part of the registration dossier is analyzed;
• analysis of expert opinion, appointment and conduct of clinical trials;
• analysis of test reports, appointment and conduct of the second stage of examination, during which data from clinical trials are studied;
• issuance of RU. Having issued a registration certificate for medical equipment, Roszdravnadzor enters information about it into the Unified Register.

Testing

The main purpose of the registration procedure is to ensure that only those medical products that meet the established requirements for quality, effectiveness and safety for the person purchasing the product are allowed on the market. In order to confirm such compliance, the current procedure provides for mandatory three types of tests for each registered product:

• technical, which are carried out to verify compliance of the actual characteristics of the product with established quality and safety standards and information specified in the manufacturer’s operational documentation;
• toxicological, within which the safety of the product for the user is monitored, subject to the manufacturer’s recommendations on the procedure for its use;
• clinical, which tests the effectiveness of a product to achieve the medical purposes for which it is manufactured.

For some types of goods, such as measuring instruments, in addition to the listed tests, control is organized in order to approve the type of product.

Test organization

All three types of tests listed are mandatory for most categories of medical devices that are submitted for registration. But the order in which they are carried out depends on which risk class a particular product belongs to:

• for goods of risk class 1 and products of the in vitro category, technical, toxicological and clinical tests are organized by the applicant himself at the stage of drawing up the registration dossier and preparing for filing an application with Roszdravnadzor;
• For goods that belong to risk classes 2a, 2b and 3, at the preparatory stage only technical and toxicological tests are carried out by the applicant. Clinical trials are carried out as part of the medical device registration service by an accredited medical organization as directed by Roszdravnadzor. This procedure is provided to ensure objectivity and guaranteed high quality of research into products that could potentially become dangerous to consumers.

List of documents for registration of RU

To obtain a registration certificate, the product manufacturer or an authorized person submits an application in the established form to Roszdravnadzor. It must contain all the necessary data specified in paragraph 9 of Resolution No. 1416. A package of documentation confirming the properties of the product must be attached to the application. The full list of required documents is in paragraph 10 of Resolution No. 1416. It includes the following items that all applicants are required to provide, regardless of what medical product they intend to register:

• a copy of the power of attorney or certificate confirming the authority of the person applying for registration to act on behalf of the manufacturer;
• information about regulatory documentation that applies to this product;
• the manufacturer's technical and operational documentation for this product, regulating its use, including an operating manual or instructions for use;
• high-quality photographs of the product measuring at least 18*24 cm. If the full use of the product requires the use of any accessories and devices, these items must be depicted in the photograph;
• protocols of all types of tests carried out by the applicant at the stage of preparation for filing a registration application in accordance with the requirements of current legislation. For products in the in vitro category and products of risk class 1, it is necessary to provide clinical, technical and toxicological test reports. For products classified as risk classes 2a, 2b and 3 - clinical, technical and toxicological test reports. For measuring instruments, test reports carried out for type approval are additionally provided;
• a list of documents submitted as part of the registration dossier.

In addition to the listed documentation, the applicant may be required to provide additional data, the composition of which depends on the type of product submitted for registration. Thus, manufacturers of goods of risk classes 2a, 2b and 3, in order to obtain a registration certificate, have the right to submit a plan for conducting clinical trials of the product, if they have developed one. Representatives of foreign manufacturers will have to include in the package of documents a permit to import samples of goods for registration and documentation confirming the quality of the product and its constituent drugs, which is issued in accordance with the legislation of the country of manufacture - for example, a State Registration Registration Certificate, or other document.

Do I need to include a receipt for payment of the state duty in the package?

It's not obligatory. Roszdravnadzor will receive information about payment of the fee from the relevant government bodies as part of interdepartmental cooperation.

What to do if a mistake was made when preparing documents?

In this case, the department will inform the applicant about the need to correct the error or provide additional documents. He was given 30 days for this. If the applicant does not meet the specified deadline, the registration procedure will have to begin again.

Registration deadlines

The maximum duration of the service for state registration of medical devices is 50 working days plus the duration of clinical trials. Such deadlines are established for products of risk classes 2a, 2b and 3. The total duration of the procedure for products of risk class 1 and goods in the in vitro category is 32 working days.

Documents confirming the right of ownership of housing

To documents that are title-establishing, i.e. establishing the subject’s right to a property include:

1. Various contracts, transactions for the alienation of housing (purchase and sale, exchange, donation, etc.). It is necessary to take into account that such documents must be properly executed and must be properly registered
2. Certificates of putting the facility into operation after construction
3. Certificates of inheritance rights issued by a notary
4. Court decisions (which must have entered into legal force) or a settlement agreement between the parties approved by the court. In this case, such a decision must enter into legal force, i.e. go through the cassation, supervisory or appeal courts.
5. Certificates of payments in cooperatives (housing cooperatives, DSK, GSK). Such certificates must also contain all the data about the object itself, its owner, as well as all information regarding the date and amount of all payments.

This is a very approximate list of all those acts and papers that can serve as full confirmation of your right to your housing.

A complete list of such documents can be found in the Law of the Russian Federation On State Registration of Real Estate Rights and Transactions, which came into force in January 1998.

Validity period of the RU

According to paragraph 6 of Resolution No. 1416, the registration certificate for devices, equipment and other types of medical products is valid indefinitely.

It should be taken into account that from January 1, 2021, registration according to the national rules of the Russian Federation will cease: applicants who submit their products for registration for the first time will have to go through all the necessary procedures according to the rules of the EAEU, which are described in the Decision of the Council of the Eurasian Economic Commission dated 02/12/2016 No. 46 .

Previously issued certificates for medical devices will remain valid and their validity period will be unlimited.

The exception is documents received during simplified registration.

In particular, the registration certificate according to Resolution No. 299 is valid for 150 days. During this period, holders of temporary certificates will have to conduct clinical, technical and toxicological tests of their product and submit their results to Roszdravnadzor in order to obtain a permanent registration certificate in place of the temporary one;

A special procedure is associated with registration certificates obtained under Decree of the Government of the Russian Federation dated April 3, 2020 No. 430 “On the peculiarities of the circulation of medical devices, including state registration of a series (batch) of medical devices.” Decree of the Government of the Russian Federation dated November 13, 2020 No. 1826 approved changes, according to which all RUs issued before the date of entry into force of the changes (that is, before November 24, 2020) are valid until January 1, 2022, but must be replaced before January 1 2021 Previously, the validity period of the RU was limited to January 1, 2021.

Replacement of RU is carried out without going through the state registration procedure for this series (batch). It is necessary to submit an application for state registration of a medical device to the Federal Service for Surveillance in Healthcare and attach the original registration certificate to it.

As a result of the replacement, Roszdravnadzor will issue a reissued registration certificate, and will also return the previously issued RU with a note indicating its invalidity (indicating the date of issue of the reissued document). The corresponding entry is made in the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices.

Legal services for obtaining a registration certificate

B&O Barristers provides a variety of legal support services to medical device manufacturers. Our lawyers and experts will accompany you from the moment of testing the medical device until the moment you receive the registration certificate. Our services include:

• Consulting you on all stages, features and pitfalls of medical device registration procedures both within the framework of national legislation and according to the rules of the EAEU;
• Organization of technical, clinical and toxicological tests and research of medical devices;
• Assistance in passing the conformity assessment of medical devices (declaration and certification);
• Development of technical and operational documentation for MI;
• Filling out an application and a set of documents for medical device registration;
• Appeal against refusal to register a medical device;
• Other legal services.

Registration fee

Mandatory registration of medical devices and other products used in healthcare will require the payment of two government fees.

How ATTEK works

ATTEK Center is a team of highly qualified professionals who have been working in the market for providing services to support the state registration of medical products for many years. The algorithm for cooperation with our customer center looks like this.

1. Submitting an application for a service. Consultation with the manager, clarifying tasks and drawing up a work plan. Providing available documents.
2. Organization of tests in an accredited laboratory by our specialists, preparation of protocols based on test results. Assistance in collecting and processing missing documentation.
3. Submitting an application to Roszdravnadzor. Monitoring the application processing process, including compliance with procedure deadlines.
4. Obtaining a certificate. Control of entering information about the document into the Unified Register of Registered Medical Products.

Check out the cost of ATTEK center services

Authenticity of documents for an apartment - how to check?

First of all, when you are planning to purchase real estate, you need to make sure that all the papers confirming the right of the current owner of this property are indeed genuine.

First, you need to familiarize yourself with the documents themselves - they must be correctly drawn up, not contain erasures, blots and similar deviations, they must indicate all the necessary data in full, all signatures, necessary seals and stamps must be in place.

You also need to check:

• The authenticity of the registration of the specified document in the body that registers the right to housing
• The authenticity of the certificate (if in this case there is a certificate of the right to inheritance) through the notary who issued it.