Procedure for the payment of fees for procedures before the Medical Devices Directorate – Nicaragua

By: Gelmis López

In compliance with circular ANRS-MLRG-5444-08-22 issued by the National Health Regulation Authority (ANRS) on the elimination of payment orders, the Medical Devices Directorate informs users of the following:

Procedure for the payment of procedures:

1. The procedure for the payment of fees to be paid by all users who carry out procedures before the Medical Devices Directorate (DDM) is modified.
   Circular ANRS-DDM-BRML-0062-01-22 “Procedure for the request of payment orders for procedures before the Medical Devices Directorate” is repealed.
2. The payment of fees for procedures before the DDM shall be made according to the new procedure detailed in point A of Annex I of this circular.
3. All procedures to be carried out before the DDM must be paid in advance at the MINSA Central Cashier’s Office.
4. The files for registration, renewal, post-registration changes must be accompanied by the pink receipt issued by the Central Cashier’s Office and a photocopy of the receipt.
5. Payments will be valid for 6 months counted from the date of cancellation of the fee. In the case of exceeding this period, the fee must be paid again.
6. Payments are not transferable for other procedures.
7. Once the fee has been paid, the payment is non-refundable.
8. The procedures of sanitary registrations, replacement of sanitary registrations and publicity must be paid one by one for each procedure so that each procedure has its own receipt, in the case of generating a single cash receipt for several procedures, only the payment for one procedure will be recognized. In other words, each application submitted to DDM must have its own pink MINSA cash receipt.
9. In the case of several post-registration changes for the same product, a payment receipt may be issued indicating more than one payment.
10. Advertising materials that are rejected and the user wishes to reinstate his/her application must pay the fee again.
11. Applications for the various procedures before DDM will be evaluated according to the legal provisions established for the same.

This circular is effective as of September 1st of this year.

If you need any advice, you can contact our team of professionals in the Life Sciences-Regulatory Affairs area through the communication channels indicated in our platforms