Seven Questions on Medical Device Testing for Approval in Russia.

Russian medical device registration system relies on product testing, and this testing must be completed regardless of whether the device already has FDA, European or other countries` approvals. According to the registration procedure this testing should be done before submission of the registration dossier. The main regulation for medical device testing is The Order #2N by Russian Ministry of Health dated 09.02.2014 (link in Russian). Here I would like to provide the most common questions on this topic:

  1. What tests should be performed for the registration of medical devices in Russia?
    -Before submission all medical devices must pass through technical testing.
    -For active medical devices, testing for electro-magnetic compatibility (EMC) is a mandatory part of technical assessment.
    -If a medical device or it`s accessory has a contact with patient`s body, toxicological testing must be completed.
    – If a medical device is sterile or has a contact with a blood, sterility, pirogenicity and hemocompatibility testing are a mandatory part of toxicological testing.
    – If a medical device is considered to have measuring function, special testing on measurement assessment should be done.
    ***
  2. Who defines which laboratory will perform tests?
    The applicant (manufacturer or its representative) can chose a testing laboratory. Technical, toxicological and EMS testing are usually performed by different centers. The testing laboratory must be accredited by Russian medical device regulator (Roszdravnadzor).
    ***
  3. What should I provide to a laboratory in order to start technical testing?
    Usually the following items are required:
    -Samples of a medical device,
    -Application form,
    -Copies of technical reports performed by the manufacturer,
    -Special testing equipment (if applicable in technical file),
    -Information about clinical application of a medical device,
    -Risk management file for a medical device,
    -Technical file and instruction for use,
    Photo of a medical device,
    -Technical drawings or charts.
    ***
  4. Can technical testing be completed without samples?
    Yes, the technical testing can be completed without providing samples in limited cases: if a medical device is subject to special authorizations or special conditions for installation or/and requires construction of specialized capital facilities. In this case testing can be performed under form of data/document analysis or manufacturing site inspection.
    ***
  5. What exactly is tested in a technical laboratory?
    Technical lab will:
    -Identify a medical device and confirm it`s classification, customs (OKP) code and safety class,
    -confirm that a medical device is compliant with requirements and characteristics described in the technical documentation,
    -Confirm that medical device is compliant with applicable Russian standards e.g. GOST 50444-92 General specifications for Medical instruments, apparatus and equipment, GOST 50267.0.2-2005 General requirements for safety. Electromagnetic compatibility. Requirements and test methods for medical devices , GOST R ISO 14708-1-2012 for implantable medical devices etc.
    -confirm that technical documentation contains full set of characteristics and is compliant with Russian regulations and national standards.
    ***
  6. What should I provide to a laboratory to start toxicological testing?
    Usually the following items are required:
    -Samples of a medical device,
    -Application form,
    -Technical file and instruction for use,
    -Copies of biocompatibility reports performed by the manufacturer,
    -Documents with a detailed description and chemical composition of all materials of a medical device and its accessories,
    -For combination products containing medical drugs, pharmacopeia reference should be provided.
    ***
  7. What exactly is tested in a toxicological laboratory?
    Toxicological laboratory will confirm that a medical device is compliant with national standards e.g. GOST ISO 10993 biocompatibility standards or specific GOST 52770-2007 standard for toxicology testing and will confirm its biological safety.

Do you have other questions on this topic? Post them here!

2 thoughts on “Seven Questions on Medical Device Testing for Approval in Russia.

  1. What should we do if a Pharmacopea monograph/reference for drug used in combination products is missing? What kind of document may serve as substitute?
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    • Hi Liudmila,

      Even if there is recommendation to provide Pharmacopeia reference, based on my experience, it is not always mandatory and you can include detailed description of the drug in the technical dossier…. In the same time Russian standard is quite unclear on this topic:

      According to clause 10.3 of Russian standard GOST 54329:
      If the medical device includes a drug (s) agent (s), then the technical file should contain detailed information on the applicable drug (s) , its (their) identity and the source (s), reasons of its “inclusion” in a medical device, and detailed information on safety

      There is also another recommendation from Roszdravnadzor and expert organizations to provide Russian registration certificate for medical drug (if available) in the registration dossier.

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