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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