Registration of medical devices. WHAT IS IT ABOUT?

Registration of medical devices is a state process, the purpose of which is to issue a Registration Certificate and to ensure that only high-quality and safe products enter the Russian market.

According to Part 4 of Article 38 of Federal Law No. 323-FZ dated November 21, 2011 “On the Fundamentals of Public Health Protection in the Russian Federation”, for a medical device to be marketable in the Russian Federation, it should be registered by the federal executive body authorized by and in the manner established by the Government of the Russian Federation.

State registration of a medical device is confirmed by a Registration Certificate. The Registration Certificate form is approved by the Registering Authority.

Registration Certificates are issued for an indefinite period of time.

In pursuance with Decision of the EEC Council No. 46 dated February 12, 2019, until December 31, 2021, an application for assessment or registration of a medical device can be submitted in the manner prescribed by national rules. In this case, a medical device may be registered in the manner prescribed by the laws of the Member State, where Registration Certificates will be valid for an indefinite period of time.

The Order of the Federal Service for Surveillance in Healthcare No. 3371 dated May 06, 2019 approved the Administrative Regulation of the Federal Service for Surveillance in Healthcare for the Provision of a State Service of State Registration of Medical Devices.

The procedure for state registration has been approved by Decree of the Government of the Russian Federation No. 1416 dated December 27, 2012 “On Approval of the Rules for State Registration of Medical Devices”.

WHAT WE DO

Experienced staff of Rezultat Audit will prepare all the documents required in accordance with the Rules for State Registration of Medical Devices.

Proper quality of the documents and lack of inaccurate information ensures that the state registration process is completed successfully and as quickly as possible, which is the end goal of our work.

We provide professional assistance in the development, adjustment and preparation of all the necessary documents for registration dossiers. These include the following:

- Application for state registration of the medical device;

- Information about regulations of the medical device;

- Manufacturer’s technical documentation for the medical device (an extract from the technical file or technical specifications; risk management file; manufacturer’s reports; qualification test reports);

- Manufacturer’s operational documentation for the medical device;

- Documents certifying the results of technical tests of the medical device;

- Documents certifying the results of toxicity testing of the medical device;

- Documents certifying the results of tests for measuring instrument pattern approval for the medical device;

- Documents certifying clinical efficacy and safety of medical devices.

MEDICAL DEVICE TESTING

State registration of medical devices is based on the results of technical tests, toxicity testing, clinical trials, and tests for measuring instrument pattern approval.

The requirements for the assessment of conformity of medical devices in the form of technical tests, toxicity testing, and clinical trials of medical devices for the purposes of state registration of medical devices are set out in Order of the Ministry of Health of the Russian Federation (Minzdrav of Russia) No. 885n adopted in Moscow on August 30, 2021 “On Approval of the Procedure for the Assessment of Conformity of Medical Devices by Technical Tests, Toxicity Testing, and Clinical Trials for the Purposes of State Registration of Medical Devices”.

The results of technical and toxicological testing, as well as tests for measuring instrument pattern approval are certified by relevant documents issued by testing laboratories (centers) that have the right to test medical devices for the purposes of their registration, on the basis of an Accreditation Certificate issued by the Authorized Body (the Federal Accreditation Service of Russia (Rosaccreditation)).

The results of clinical trials are certified by relevant documents issued by medical facilities that conduct clinical trials of medical devices on the basis of a license for medical activities issued by the Authorized Body and accredited by Roszdravnadzor.

The results of clinical and laboratory testing of in vitro diagnostic medical devices are certified by relevant documents issued by clinical diagnostic laboratories (CDLs) that are licensed for medical activities and accredited by Roszdravnadzor to conduct clinical trials of in vitro medical devices.

WHAT WE DO

Rezultat Audit cooperates with reliable laboratories and medical facilities whose powers are duly certified.

We guarantee that the testing required for the purposes of state registration will be conducted to the highest standard and test results will be obtained in accordance with all the requirements prescribed and within the clearly defined time frames.

IMPORTATION OF MEDICAL DEVICES TO THE RUSSIAN FEDERATION

For the purposes of state registration, an import permit is required for a medical device of foreign origin.

For the purposes of state registration, the procedure for the importation of medical devices to the Russian Federation has been approved by the Order of the Ministry of Health of the Russian Federation No. 661n dated June 30, 2020.

Our specialists will help you to complete an Application for Medical Device Import as accurately as possible to reflect all the information required about the product, taking into account the requirements for the number of product units for all the necessary tests.

WHAT WE DO

Once an Application for Registration and documents required by the Rules for State Registration of Medical Devices are ready, they will be filed to the Registering Authority. However, Rezultat Audit is not giving up on you past this stage. Our Registration Specialist will provide you with full support for the state registration process with the Registering Authority throughout all the stages and will professionally resolve any issues that may arise at any stage of the state registration process.

STAGES OF STATE REGISTRATION

1. The Registering Authority makes a decision to start the process of state registration of medical devices.
2. The Registering Authority verifies the information contained in the registration dossier documents for accuracy and completeness, including, without limitation, by comparing it with data provided in the course of inter-agency information exchange.
3. If any violation and/or missing documents are found at this stage, the Registering Authority gives the Applicant a notice to correct the defects within 30 days. If the Applicant corrects the defects and/or submits the missing documents within the 30-day period, the Registering Authority makes a decision to start the process of state registration of medical devices.
4. The Registering Authority must complete state registration of medical devices (excluding any listed medical devices) within a period of up to 50 business days after the decision is made to start the process of state registration of medical devices. The 50-day period does not include the period of clinical trials of the medical device.
5. The Registering Authority shall prepare and issue the Terms of Reference for the Assessment of the Quality, Efficacy and Safety of the Medical Device to a federal state budgetary institution under control of the Registering Authority.
6. Assessment of quality, performance and safety of the medical device:

- The Application for Registration and other documents in the registration dossier is assessed to determine whether clinical trials of a medical device can be performed.

- If the available materials and information are not sufficient for an expert to make an opinion, a request for further information indicating the nature of the observations and the way to eliminate them is sent to the Applicant.

- The Applicant must respond to the Registering Authority’s request within a period of up to 50 business days after the date of receipt thereof.

- The period of assessment of the quality, efficacy and safety of a medical device does not include the time between the date the Registering Authority’s request is given and the day a response to it or a notice of failure to respond is received.

7. An opinion on whether clinical trials of the medical device can be performed (indicating the reasons and justification for the impossibility to conduct clinical trials) is prepared and sent to the Registering Authority. The opinion form is to be approved by the Ministry of Health of the Russian Federation.
8. The Registering Authority makes a decision on issuing a permission for clinical trials of the medical device or refusal of state registration of the medical device.
9. Clinical trials shall be conducted on the basis of the permission for clinical trials issued by the Registering Authority and the opinion on the ethical validity of clinical trials issued by the Ethics Committee at the Ministry of Health of the Russian Federation in cases defined by the said Rules.

N.B.:

Clinical trials of a medical device are carried out by medical facilities that are compliant with the requirements approved by the Ministry of Health of the Russian Federation. The compliance of a medical facility is determined by the Registering Authority in the manner prescribed by the Ministry of Health.

10. The Registering Authority makes a decision to suspend the process of state registration.
11. Upon the completion of clinical trials of the medical device, the Applicant shall file an Application to Resume State Registration of the Medical Device and the results of the clinical trials of the medical device with the Registering Authority.
12. The Registering Authority makes a decision to resume the process of State Registration of the Medical Device.

If the submitted documents are incomplete or contain inaccurate data, the Registering Authority shall issue a decision to return the Application to Resume State Registration of the Medical Device along with the said documents to the Applicant, which indicates the reasons for the return. At the same time the Registering Authority informs the Applicant of whether the Application to Resume State Registration of the Medical Device may be re-submitted along with the refined documents.

13. The Registering Authority shall forward the results of clinical trials of the medical device delivered by the Applicant to an Expert Organization.

The Expert Organization shall assess the results of the trials and testing for completeness and issue an opinion on the assessment of the quality, efficacy and safety of the medical device in the form to be approved by the Ministry of Health of the Russian Federation and send it to the Registering Authority no later than 10 business days after the date it receives the submission.

14. The Registering Authority shall assess the opinion on the assessment of the quality, efficacy and safety of the medical device and make a decision on whether to provide or refuse state registration of the medical device.