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DON’T PLAY ROULETTE WITH YOUR RUSSIAN TEST REPORTS
Local preclinical and clinical testing has been a long-standing requirement for medical device registration in Russia. This is a fairly unique requirement. While some countries like China may also require local test data, most countries will accept test data generated in any country, if both countries follow the same international standards and regulations (e.g., EN 60601-1). At the same time, it can be said that medical device registration applications in Russia are increasingly delayed by the local testing requirements.
Test Labs See Increased Oversight
First, the number of local laboratories, accredited by the Russian Authority (Federal Authority for Accreditation, also known as RosAccreditation), is shrinking, causing a bottleneck in demand. In recent years, RosAccreditation has been increasingly active in auditing Russian laboratories with a noticeable uptick in laboratories that have had their accreditation partially suspended, suspended or even revoked completely.
Even some of the largest, most widely used laboratories have been affected such as the Federal State Budgetary Institution “Federal Research and Clinical Center of Physical-Chemical Medicine of the Federal Medical Biological Agency” which had its accreditation outright terminated. Another popular testing lab for medical devices and IVDs, Testing Laboratory of Equipment Safety “Electrontest”, LLC had their accreditation temporarily suspended from August to November of 2019, while Certification Center of Medical Equipment “CCME VNIIMP”, LLC had theirs temporarily suspended before a decision was made to completely terminate their accreditation.
In order to assist manufacturers to identify accredited labs, RosAccreditation maintains an online Register of Accredited Conformity Assessment Bodies. While open to the public, it can be slow and a little difficult to effectively navigate.
What to Watch Out For
First and foremost, manufacturers’ that have existing, active registrations supported by test reports issued by laboratories that have lost accreditation will NOT be affected and their registrations will remain valid. However, manufacturers currently seeking, or planning to seek, approval must be cautious when selecting testing labs. At any time during RZN’s application review (practically speaking from the importation of samples for testing until formal application approval), the registration process can be jeopardized by the loss of accreditation by the lab issuing supporting test certificates. Unfortunately this is increasingly common.
Two Common Problem Scenarios
The manufacturer’s test lab loses accreditation after issuing test reports but before submitting the application.
The manufacturer must re-run the tests through a new lab (requiring 4 to 6 weeks) including the importation of new samples (requiring up to 2 months)
The manufacturer’s test lab loses accreditation after the application has been submitted.
When RZN comes back with questions or requests additional test data, all new testing certificates will be required as test labs in Russia do not provide supplemental testing on certificates issued by other Labs. Given responses to application insufficiencies are required within 50 working days, manufacturers are hard pressed to generate new test reports in time and applications are rejected.
ASIA ACTUAL CAN HELP
Considering the complexity of the importing test samples and the risk of test laboratories losing accreditation, it is important for manufacturers seeking medical or diagnostic device registration in Russia work with an experienced, local partner who can make an informed selection of test laboratories and take fast corrective action should the selected lab be affected.
If you’re considering market entry in Russia, Asia Actual has experienced, local professionals that can help you select the right local laboratory and navigate the unique regulatory hurdles. Please contact Asia Actual for a free consultation about Russian test reports.