MEDICAL DEVICE REGISTRATION AND APPROVAL IN Tajikistan

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
Last update: December 2022

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.

For more information on Medical Device Registration in Tajikistan, check out the following article: Country at a glance: Tajikistan

Other Central & East Asia Countries: Afghanistan, India, Japan, Kazakhstan, Kyrgyzstan, Nepal, Russia, South Korea, Sri Lanka, Taiwan, Tajikistan, Uzbekistan

 

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