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.
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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).
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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.
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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.
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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.
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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.
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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.

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