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Pricing Proposal NHRA

The document proposes pricing for medical device authorization representative licensing services and medical device registration services provided by Adliya Business Center Co W.L.L. Table 1 lists proposed fees for licensing of class A through D authorization representatives on a first license and renewal basis. Table 2 lists proposed fees for registration of low, medium, and high risk medical devices on a first registration and renewal basis, as well as fees for registration requests and updates. The services are provided in cooperation with NHRA under an MOU to facilitate the application process through an online portal assisted by bio-medical engineers.

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Mohamed Ezzat
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0% found this document useful (0 votes)
75 views2 pages

Pricing Proposal NHRA

The document proposes pricing for medical device authorization representative licensing services and medical device registration services provided by Adliya Business Center Co W.L.L. Table 1 lists proposed fees for licensing of class A through D authorization representatives on a first license and renewal basis. Table 2 lists proposed fees for registration of low, medium, and high risk medical devices on a first registration and renewal basis, as well as fees for registration requests and updates. The services are provided in cooperation with NHRA under an MOU to facilitate the application process through an online portal assisted by bio-medical engineers.

Uploaded by

Mohamed Ezzat
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Dear Dr.

Mariam Adhbi Al-Jalahma,


NHRA CEO.

It is our pleasure to share with you our proposal regarding Medical devices Authorized
representative Licensing services & Medical device registration services:

Whereas we are, (Adliya Business Center Co W.L.L (ABC) associated under the MOU signed
on February 1st 2021 with you (NHRA).

Regarding this cooperation, our company has created a website that will facilitate the application
process, by entering the site without any complications in progress, as our Bio-Medical Engineers
will review the applications and assist the facilities to complete the requirements by guiding them
through the laws and regulations of NHRA.

In this regard, we are pleased to present a pricing proposal for the following
services tables below:

- Table No.1 Medical devices Authorized representative


Licensing services.

- Table No.2 Medical device registration services


Proposed pricing for Services & Requests for Medical Devices
Registration in NHRA.

Table No.: 1
Medical devices Authorized representative Licensing services:

Service Type Item Type Fees Norm


(Dinar Bahraini)
Each new
License Application fee 25
order
First license 500 First license
Class A
License renewal 350 Annual
First license 350 First license
Class B
Authorized Representative License renewal 250 Annual
licensing First license 250 First license
Class C
License renewal 150 Annual
First license 150 First license
Class D
License renewal 100 Annual
500 First license
Medical devices Warehouse licensing
400 Annual
2,500 First license
Medical devices manufacturer licensing
1,500 Annual
Update medical device facilities data 25 Each request
Re-inspection of medical device facilities 25 Each request

Table No:2
Medical device registration services:

Service Type Item Type Fees Norm


(Dinar Bahraini)
Request to submit a registration request 5 Each new
device
First registration 75 Annual per
license
Low risk
Registration renewal 50 Annual per
license
First registration 150 Annual per
Medical device license
Medium risk
registration Registration renewal 100 Annual per
license
First registration 500 Annual per
license
High risk
Registration renewal 350 Annual per
license
Update medical device registration data 10 Each device

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