Medical Device Registration and Approval in Tajikistan
General country-specific regulatory information is provided on this page for medical device registration and approval in Tajikistan. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Tajikistan, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification in Tajikistan
REGULATORY AUTHORITY: State Supervision Service for Health Care and Social Protection of the Population of the Republic of Tajikistan (Pharmnadzor)
CLASSIFICATION SYSTEM: Not applicable.
TIMEFRAME: State Registration Procedure (MD/IVDs – all classes): 2-5 months.
SPECIAL REQUIREMENT: During the secondary (specialized) examination, experts will evaluate whether local testing or clinical trial is necessary.
LOCAL FEES (New Application): State Registration Procedure (MD/IVDs – all classes): USD 1,036.
LOCAL FEES (Manufacturer): No manufacturer review fees are required.
LICENSE VALIDITY: The registration certificate will be valid for 5 years and the renewal application should be submitted not later than 3 months before the expiry of the registration certificate. The renewal procedure and its duration are almost identical to the initial registration.
LICENSE TRANSFER: License transfers are not possible.
AUTHORIZED REPRESENTATIVE: Foreign manufacturers must appoint a local company as their Authorized Representative (AR) and will be responsible for the registration activity.
ADDITIONAL INFORMATION: In addition to the registration certificate, import permit is also required. This import permit will be valid for one year and can be used for multiple importation.
Last Updated: April 20, 2021
For more information on Medical Device Registration in Tajikistan, check out the following article: Country at a glance: Tajikistan
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