Medical Device Registration in Russia
I. Registration procedure
The medical device registration in Russia is complex, because very few
English files are accepted. Therefore, a local expert shall be hired to
participate in the review until the success completion of the registration.
In this article, the individual/company refers to the “applicant”, which
shall not be confounded with the manufacturer.
Main processes include:
1) Determine whether there is any equivalent device approved in the
Russian Federation.
2) Determine the device class.
3) The officer confirms the test requirements for your product.
4) Apply for the test sample.
5) Test by a medical and test center authorized by the Russian government.
6) Accept the test and medical report results.
7) Prepare the registration files, including the test result and the
medical report.
8) Submit all files.
9) Apply for sanitary certificate (if it is applicable to your product).
10) Apply for the GOST R certificate and the GOST-K certificate.
11) Add the product to the roszdravnadzor database to publish on its
website.
12) The registration, sanitary (if applicable) and GOST-R certificates,
and other typical international business vouchers (such as clearance of goods,
declaration of conformity to Russian standards, laws and regulations) are required
to export devices to Russia.
II. File Requirements
All required documents and certificates must be translated into Russian.
Official documents must be notarized and certified.
The document shall have the seal and the signature of the applicant.
The registration certificate is valid as long as the following aspects of
the product remain unchanged.
1) Quality, efficiency and safety of products;
2) Adverse effect or usage limitation;
3). Name of the manufacturer;
4) Trade name;
5) Package;
6) Registration document.
The submitted technical dossier must include the following documents:
1) Application form;
2) Device information table.
The information provided shall include the usage and basic characteristics
of the medical device.
3) Supporting documents.
For example, country of origin certificate.
The document must be notarized and certified by the Russian Consulate
Office.
4) Letter of authorization to the applicant.
The manufacturer must formally authorize the applicant (counselor or
distributor) to apply for registration on behalf of the manufacturer.
The document must be notarized and certified by the Russian Consulate
Office.
5) Prove that the manufacturing of medical products conforms to the law of
the Russian Federation.
It sounds confusing, but in essence, the manufacturer just needs to prove
that the production process meets the requirement.
Examples of supporting documents include ISO certificate, CE certificate
and CFS.
These documents must be notarized and certified by the Russian Consulate Office.
6) Draft of the legal document, compliance documents, technical conditions
or standards of the medical product to be certified.
7) Instruction for Use.
8) Document proving the equivalence to similar products marketed in the
Russian Federation (if any).
9) Test results.
Including technical test, safety evaluation (toxicology, electromagnetic
compatibility), safety and performance tests conducted by two different
independent hospitals or clinics.
The document must be the original copy signed or sealed by the applicant,
technical center and hospital.
10) Photo of the device.
11) Publicity materials.
12) List of all provided documents.
13) Product sample, if required.
To pass the Russia Customs, the medical device must have one or two of the following certificates. Both can be obtained only after the issuance of the registration certificate:
1) Sanitary certificate
2) GOST-R quality certificate
Therefore, the manufacturer or the applicant must apply for and obtain the corresponding permission so that the sample can pass the customs.
All documents and letters must be in Russian.
After the sample is received, the next step is to submit the sample and required documents, including the test and medical reports of the authorized professional technical center and the hospital.
The medical reports shall be made by two different independent hospitals or clinics.
The medical device, which is implanted to the body or contacts the human skin, may influence the patient or the doctor. Therefore, a hygienic test is required for this type of medical devices.
