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MCA-F-117/02 — version 4, 19 June 2026 — Listing of Medical Devices — application form and Annex 2

Link directly to a passage with its anchor — for example #sheet-1-row-8 — to open it highlighted. This reference version is generated from the authority’s publication and does not replace it. Language: English.

B8: MEDICINES CONTROL AGENCY

B9: Off OIC Highway, Sukuta, West Coast Region, P.O. Box 3162, The Gambia

B10: Website: www.mca.gm; E-mail: info@mca.gm; Tel. No.: +2204380632

B12: LISTING OF MEDICAL DEVICES - MCA-F-117/02

B15: NAME OF APPLICANT:

B16: ADDRESS:

B17: EMAIL:

B18: WEBSITE:

B19: TELEPHONE:

B21: STATUS OF APPLICANT: C21: MANUFACTURER D21: MARKETING AUTHORIZATION HOLDER F21: IMPORTER

B24: ITEM NO. C24: NAME AND DESCRIPTION OF THE PRODUCT D24: INDICATITON/USE E24: PACKAGE SIZE & PRESENTATION F24: NAME & FULL ADDRESS OF MANUFACTURER G24: SRA COUNTRY PRODUCT APPROVED/REGISTERED H24: NAME & ADDRESS OF SOURCE

C32: FOR APPLICANT'S USE ONLY

B33: Importer Licence Number (where applicable)

B35: Name of supervising Pharmacist/Supervisor D35: Registration Number with Relevant Council

B37: Signature D37: OFFICIAL STAMP

B39: Date

B41: Name of business owner or duly authorised person

B43: I, the undersigned certify that the information provided on these products for listing is true and reflects the total informationavailable. I hereby take full responsibility and liability for any information provided.

B46: Signature

B47: Date

C52: FOR OFFICIAL USE ONLY

B53: Vetted by (Name) C53: Signature and Date D53: Designation

B56: Approved by C56: Signature and Date D56: OFFICIAL STAMP

B64: Annex 2 - Guideline for Listing of Medicines and Related Products MCA-F-117/02, version 4 – 19 June 2026