Date:04/03/2021 National Gazette No: 3513 Resolution No. (24) for 2021 Amending some provisions of Resolution (20) for 2016 on the definition of fees for private healthcare facilities Minister of Health: After reviewing Law No. 38 of 2009 with the establishment of the National Health Regulatory Authority, amended by Decree No. (32) of 2015، and the decree - Law No. (21) of 2015 regarding private healthcare facilities, amended by Law No. 1 of 2019, and in particular Article (28) of it, and Decree No. (5) of 2013 for establishing the Supreme Council of Health and its amendments, and resolution (20) for 2016 on the definition of the categories of fees for private healthcare facilities, and Resolution (48) of 2020 on the control of the quality of medical devices and products, in particular article (17) of it, Based on the proposal of the Supreme Council of Health, After cabinet approval, It was decided,
Article 1
Article 1 To add table (3- Table of services and requests for medical devices and products) attached to this decision on the services and requests of medical devices and products at the National Health Regulatory Authority, to the tables listed in article (1) of resolution (20) for 2016 on the categories of fees of private healthcare facilities.
Article 2
Article 2 The Chief Executive of the National Health Regulatory Authority must execute this decision, and it should be implemented a month after it is published in the national gazette. Minister of Health Faeqa Saeed Al-Saleh Issued on 17 Rajab 1442 E Correspondence to 1st of March 2021
Table (3) heading — (3) Schedules of services and requests for medical devices and
(3) Schedules of services and requests for medical devices and products in the National Health Regulatory Authority
Table #1 — Table #1
Table #1Medical devices Authorized representative Licensing services Service Type Item Type Fees Norm (Dinar Bahraini) Each new License Application fee 50 order First license 1,000 First license Class A License renewal 700 Annual First license 700 First license Class B Authorized Representative License renewal 500 Annual licensing First license 500 First license Class C License renewal 300 Annual First license 300 First license Class D License renewal 200 Annual 1,000 First license Medical devices Warehouse licensing 800 Annual 5,000 First license Medical devices manufacturer licensing 3,000 Annual Update medical device facilities data 50 Each request Re-inspection of medical device facilities 50 Each request
Table #2 — Table #2
Table #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 150 Annual per license Low risk Registration renewal 100 Annual per license First registration 300 Annual per Medical device license Medium risk registration Registration renewal 200 Annual per license First registration 1,000 Annual per license High risk Registration renewal 700 Annual per license Update medical device registration data 20 Each device
Table #3 — Table #3
Table #3Medical devices importation services Service Type Item Type Fees Norm (Dinar Bahraini) Medical Registered 0.5 Each type device Unregistered 2 Each type Request approval to import a IVD/combined Registered 1 Each type single device medical Unregistered 3 Each type device Verify the validity of the quality certificate 5 Each type regular 20 Each type Product classification request Urgent 40 Each type Demurrage for the device till approval 100 Per day Each Issuing a product classification certificate 15 certificate Sample examination 5 Each type Inspecting the shipment at the port 10 Each type
Table #4 — Table #4
Table #4 Other services Service Type Item Type Fees (Dinar Bahraini) Submit a request for approval to use 0.5 Each device Permit to use the device Evaluate the viability of the product 50 Each device Issuing certificates for medical manufacturer and 10 Each request devices, free sale and other paper documents Product disposal supervising 25 Each request