Issue of Permit to Import Medical Equipment

Service completion duration

From 1 to 3 working days for pre-import applications - From 1 to 2 working days ...

Service fees

Application fee: AED 100
Shipment clearance issuance fee: 1% of the invoice...

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About the Service

This service allows obtaining a permit to import medical equipment for the local agent who holds a valid medical store license issued by MOHAP.

Service Process

1
To apply for e-services, create an account on MOHAP website or smart app with a username and password. Submit an initial import request before shipping from the country of origin. Also, pay the application fee.
2
If the requirements and conditions are met, the pre-import request will be approved. The applicant will be notified through the registered email. The pre-import approval will be valid for sixty days from the date of its issuance, during which the shipment from the country of origin will be prepared.
3
The client must submit a shipment clearance application - upon obtaining the confirmed air / land / sea freight bill - and pays the due fees.
4
If the requirements and conditions are met, the approval is obtained electronically with a printable copy. The validity of the permit is 60 days from date of issuance, and it is conditionally approved by the MOHAP inspector. Final approval is given upon arrival of the shipment and before the market release.

Conditions & Requirements

Obtain product marketing authorization from MOHAP.
Electronic Shipment clearance permits are conditionally approved and subjected to final approval by MOHAP inspectors to clear the shipment from customs to the importing medical store, and for the purpose of marketing in the local market (for medicated medical devices), after physical inspection and conformity of the products with the original shipment documents and shipping conditions.
Only one purchase invoice should be attached for each pre-import application.
Many pre-import applications can be gathered under one shipment clearance application, provided that they are all under the same shipping bill number that should only include items subjected to MOHAP.

FAQ’s

How to find out the product or its pharmaceutical or therapeutic alternatives that have marketing authorization?
You can find the information on https://www.mohap.gov.ae/ar/services/Pages/drug-directory.aspx
I have further queries related to import and export of medical products?
Please contact: Import.export@mohap.gov.ae
How to obtain narcotic/controlled drugs authorization?
Please apply through: https://smartforms.moh.gov.ae/DEI
How to obtain Batch Release Certificate (BRC)?
Please apply through: https://smartforms.moh.gov.ae/DEI
How to obtain authorization from Federal Authority of Nuclear Regulation( FANR)?
Please visit this website for further guidance: https://www.fanr.gov.ae/ar/Pages/default.aspx
I have further quires related to product marketing authorization and/ or product classification?
Please contact: DrugReg.inquiries@mohap.gov.ae
How to obtain MOHAP license of medical store?
Please refer to: https://mohap.gov.ae/en/services/licensing-of-a-pharmaceutical-facility
Where I can find a copy of Ministerial resolution no. (22) of year 2022?
In the PDF Resources
How to obtain product classification?
Please apply through: https://mohap.gov.ae/en/services/classification-of-a-product

Service completion duration

From 1 to 3 working days for pre-import applications - From 1 to 2 working days for shipment clearance applications

Service fees

Application fee: AED 100

Shipment clearance issuance fee: 1% of the invoice value for the CIF price, not less than AED 200 per invoice

Service channels

MOHAP Website: www.mohap.gov.ae
MOHAP Smart App

MOHAP office at customs ports: only to release the shipment directly to the importing medical store after printing the electronic shipment clearance permit and presenting the documents related to conformity to the Ministry’s inspectors, and before distribution in the local market (for medicated medical devices).

Service locations

MOHAP Website: www.mohap.gov.ae
MOHAP smart App

Support

Call Center: 80011111
Email: info@mohap.gov.ae

Payment channels

E- Payment

Target audience

Medical store with a valid license issued from the Ministry of Health and Prevention

Resources

Department name

Drug

Sector name

Health Regulation

Main service

Clearance, Import and Export Permits

Service Code

110-02-007-000

Service Classfication

Transactional

Service Type

Government to Business

Related Services

This service is related to the following services:
- Licenses issued from MOHAP, for all medical products.
- BRC- batch release certificate, for biological products.
- Authorization to import narcotic, controlled or semi-controlled drugs - for narcotic products and controlled substances.
- Import permit from the Federal Authority for Nuclear Regulation (FANR)- for radioactive products, materials and radiation devices.

Service Bundle

This service is not linked to any bundles

Number of Users

40416

Number of Transactions

30314

Notes

None

Required Documents

First stage: Pre-import application: The submission must be made through the electronic system of import to obtain the pre-approval for import before initiating the shipping from the country of origin. The following documents need to be attached:
- Valid MOHAP medical store license.
- Valid MOHAP license of pharmacist in-charge, or medical equipment engineer certificate attested by the UAE Ministry of Education - for medical store that has activity of only non-pharmaceutical medical devices.
- The purchase invoice issued by the manufacturer/marketing authorization holder, including the country of origin, production, and expiry dates for each batch. The remaining shelf life of the product must not be less than two-thirds of the total shelf life.
- Information, catalog and photos for each product or item arranged as mentioned in the invoice.
- Valid product classification certificate (upon request) or valid product marketing authorization issued by MOHAP.
- Authorisation letter for distribution in the UAE from the factory to the local agent - for products that do not need to obtain marketing authorisation.
- Valid FDA certificate, or valid ISO13485 and EC quality certificates.
- Valid free sale certificate (FSC) from the country of origin.
- Valid Good Manufacturing Certificate (GMP) upon officer request.
- Product Minor Variation Certificate (MVC) - if any.
- An import permit from the Federal Authority for Nuclear Regulation - to import diagnostic radiological devices that emit ionizing radiation (X-rays), for example: radiography, medical imaging and radiotherapy, fluoroscopy, mammography, Radiotherapy and CT scan.
- Batch release certificate (BRC) - in case the product is a biological derivative - issued by MOHAP according to the batch number.
- Import Authorization of Narcotic or Controlled Drugs importation - for Narcotic and controlled drugs - in the case of importing from the designated free zones in the country, the following must be provided:
  - A valid MOHAP marketing office license of MAH (marketing authorization holder).
  - A valid certificate of good storage and distribution practice (GSDP) issued by MOHAP to MAH (Marketing Authorization Holder).
Second Stage: Shipment Clearance application: The application must be submitted when the freight bill is issued and confirmed. The following documents need to be attached:
- Air / sea / land freight bill with the necessity of shipping in containers monitored with Temperature DATA LOGGER with compliance to Ministerial Resolution No. (22) of year 2022.
- The packing list must include the total weight and the number of parcels/packages.
- Original Certificates of Analysis (C.O.A) for all imported batches, which must include production, expiry dates and be issued by the batch releaser manufacturer.