Medical devices registration in Uzbekistan
Medical device registration in the Republic of Uzbekistan
Many great opportunities, with RedMed
Uzbekistan`s population exceeds 36 million people, with 3 million living in its vibrant capital, Tashkent. Medical devices consumption rises accordingly - the market`s volume is $1,8 B in 2024, and grown 21% year-to-year, according to the State Pharmacy Committee.
The registration for medical devices in Uzbekistan is issued for 5 years, with easy renewal process
120 local manufacturers cover only 18% of the medical devices` market demand (data by the State Statistics committee).
Primary import partners for medicine are Russia, China, India, Korea and Germany.
With the RedMed team to help, the registration shall take 2-7 months.
Note: Only those manufacturers and distributors who hold a GMP/GDP certification will be allowed to participate in state procurement since 2024.
Registration Steps
Step 1. Initial documents selection, notarization and translation
We need an ISO 13485, a technical file of the device, the device`s registration certificate issued in its country of origin, and a few reports.
We provide you with a full list of required documents according to the safety class - contact us today. The full set will be translated to Uzbek language, and its translation notarized.
RedMed creates technical file, IfU in Uzbek, application for the registration - all based on requirements of Resolution of the Cabinet of Ministers of the Republic of Uzbekistan dated 23.03.2018 No. 213 'On the procedure for state registration of medicines, medical devices and medical equipment and the issuance of a registration certificate'.
Note: In case of your device holds one of these 6 registration certificates:
- Food and Drug Administration (FDA), USA;
- Conformité Européenne (CE), EU;
- European Medicines Agency (EMA), EU;
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan;
- Ministry of Food and Drug Safety (MFDS), Republic of Korea;
- Medicines and Healthcare products Regulatory Agency, (MHRA), UK
Step 2. State fee calculation and payment.
The state fee is based on a medical device safety class, a number of items going into one registration certificate, its sterility and operational scope. When the fee is due, the Committee accepts the device`s dossier for review and issuing a Registration Certificate.
Step 3. Samples for the Committee.
Uzbekistan exercises quite strict policy on samples review.
If you intend to register, say, 600 items, be ready to provide these 600 items to the Regulator. The samples later returned. Complete or partial absence of samples will lead to the return or cancellation of the dossier.
Note: If your device holds one of the 6 mentioned registration certificates, the samples won`t be requested for reviewing.
Step 4. The State Pharmacy Committee reviews the application
and issues the certificate.
We collect your Registration Certificate from Tashkent`s Regulator Office.
Step 5. Post-marketing activities for further Reg Cert extension.
When 5 years pass, the Regulator to demand a few reviews from local clinics and hospitals on device`s usage and effectiveness. We are good to provide you with users of the device and prepare the reports accordingly.
Then, a renewal of the dossier and re-submitting within the regulator is requested. State fees will be cut on half for the renewal.
For detailed expenses and process lead time please contact us:
hello@red-med.ru
Time to get: up to 7 months
Average time for the registration of medical devices in Uzbekistan with RedMed is 2 to 6 months. The registration is valid for 5 years and must be renewed at least 3 months before expiration.
The state registration for medical devices in Uzbekistan conducted by
"Center For Safety Of Pharmaceutical Products" of the Ministry of Healthcare.
The regulator`s website is www.uzpharm-control.uz
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Frequently Asked Questions about the Uzbekistani medical devices registration
Q.: Do I need a local Authorized Representative (AR) to complete the registration?
A.: AR required for the procedure, although not being mentioned in a Registration certificate.
Your local Instruction for Use will state the company responsible for quality, and will specify
local means of feedback with the manufacturer. We provide an AR in Tashkent.
Q.: What are state fees like and is it possible for us to pay state fees directly to the Regulator?
A.: The State fee is paid in Uzbek sum, UZS. A local company we use for AR functions has an UZS account for such transactions.
The State fee consists of a fixed part:
3 750 000 UZS ($300) for the Application, 750 000 UZS ($60) for the State Letterhead.
The varying part consists of state fee specific to device registered, and paid for every modification. The fees vary greatly, from 750 000 UZS ($60) to 129 000 000 UZS ($9900). Ask us for help with assessing your total fee.
Q.: My devices being produced in Korea, but not registered within Korean FDA yet. Could we apply for registration in Uzbekistan?
A.: Medical devices with no registration at its manufacturer`s country can not be registered in Uzbekistan at the moment. The Regulator asks for initial Registration Certificate being translated to Uzbek and provided for review.
Q.: Is manufacturing site inspection required during the registration?
A.: Unlike most of post-Soviet countries, Usbekistani regulator doesn`t require an inspection.
So far, the country`s Parliament intends to pass a law on the mandatory inspection for the first-time registrations.
Q.: How much time does the registration take, from A to Z?
A.: For a general registration, all of works can fit in 7 months including dossier compilation and the regulatory reviewing. For an express registration - FDA, CE, EMA, PMDA, MFDS, MHRA registration certificate holders - it will take up to 2 months.
Q.: Is the express registration certificate still valid for 5 years, or shorter?
A.: So far, any registration certificate issued in Uzbekistan valid for 5 years.
Q.: How much in advance should we begin renewal of our Uzbek registration certificate?
A.: We strictly recommend to begin in 3-4 months before the initial certificate expires. It will allow the regulator to smoothly update the dossier and issue a new registration certificate without pauses in its validity.
Q.: What else should I know when I renew my registration certificate for Uzbekistan?
A.: The state fee for the renewal will approximate 50-60% of your initial registration fee paid.
All of items stated in the certificate will be required for the reviewing, again.
For more information in regards of medical devices` regulatory affairs in Uzbekistan, write us:
hello@red-med.ru
A.: AR required for the procedure, although not being mentioned in a Registration certificate.
Your local Instruction for Use will state the company responsible for quality, and will specify
local means of feedback with the manufacturer. We provide an AR in Tashkent.
Q.: What are state fees like and is it possible for us to pay state fees directly to the Regulator?
A.: The State fee is paid in Uzbek sum, UZS. A local company we use for AR functions has an UZS account for such transactions.
The State fee consists of a fixed part:
3 750 000 UZS ($300) for the Application, 750 000 UZS ($60) for the State Letterhead.
The varying part consists of state fee specific to device registered, and paid for every modification. The fees vary greatly, from 750 000 UZS ($60) to 129 000 000 UZS ($9900). Ask us for help with assessing your total fee.
Q.: My devices being produced in Korea, but not registered within Korean FDA yet. Could we apply for registration in Uzbekistan?
A.: Medical devices with no registration at its manufacturer`s country can not be registered in Uzbekistan at the moment. The Regulator asks for initial Registration Certificate being translated to Uzbek and provided for review.
Q.: Is manufacturing site inspection required during the registration?
A.: Unlike most of post-Soviet countries, Usbekistani regulator doesn`t require an inspection.
So far, the country`s Parliament intends to pass a law on the mandatory inspection for the first-time registrations.
Q.: How much time does the registration take, from A to Z?
A.: For a general registration, all of works can fit in 7 months including dossier compilation and the regulatory reviewing. For an express registration - FDA, CE, EMA, PMDA, MFDS, MHRA registration certificate holders - it will take up to 2 months.
Q.: Is the express registration certificate still valid for 5 years, or shorter?
A.: So far, any registration certificate issued in Uzbekistan valid for 5 years.
Q.: How long does it take for the updates to the registration certificate to be applied?
A.: It usually takes 2 to 3 months for a full application of updates to existing certificate.
Q.: How much in advance should we begin renewal of our Uzbek registration certificate?
A.: We strictly recommend to begin in 3-4 months before the initial certificate expires. It will allow the regulator to smoothly update the dossier and issue a new registration certificate without pauses in its validity.
Q.: What else should I know when I renew my registration certificate for Uzbekistan?
A.: The state fee for the renewal will approximate 50-60% of your initial registration fee paid.
All of items stated in the certificate will be required for the reviewing, again.
For more information in regards of medical devices` regulatory affairs in Uzbekistan, write us:
hello@red-med.ru
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