Sierra Leone - Registration of medical devices or in vitro devices (IVDs)

Advertisement

Procedure

How to apply :

1. An application for the registration of a medical device , either locally manufactured or imported, shall be made by sending Application letter addressed to the Registrar of the Pharmacy Board of Sierra Leone, Central Medical Stores, New England Ville.
2. If the applicant is a foreign company, it shall appoint a local agent through whom an application shall be submitted.
3. The local agent shall be a registered Pharmaceutical Importation Company or an accredited manufacturer’s representative registered as a pharmacist in Sierra Leone.
4. Applicant should download the application form from the Pharmacy board website and accurately fill, dated, signed and stamped by the applicant/license holder Medical device Form
5. Attach all the required documents and pay application fees to the application forms and submit them to the Pharmacy Board of Sierra Leone Central Medical Stores Compound.
6. The application will be processed and verified, if all the information are in order the medical device will be registered ,gazetted and you will be issued with a certificate of registration within 3 months

Note :

• An appeal for the review of an application may be made in writing, to the Registrar of the Board within thirty (30) days of receipt of the rejection notice

Advertisement

Required Documents

• Dully signed Covering Letter
• Accurately filled application form
• Certificate of analysis of the finished product
• Manufacturing licences
• Sample of the product
• Free sale certificate
• Sterility certificate
• All supporting documents as specified on the application form
• Non-refundable application fee

Office Locations & Contacts

THE REGISTRAR:
Pharmacy Board of Sierra Leone Central Medical Stores Compound
New England Ville, Jomo Kenyatta Road, Freetown
P.M.B. 322
Sierra Leone
Phone: (+232 22) 228497, 225983, 229346
Fax: (+232 22) 224526
Email: [email protected]
Website: Testing and reserach
Email: [email protected]
Regional Offices- Bo, Kenema, Makeni and Kono.

Eligibility

Local and foreign manufactures

Fees

No Fees

Validity

• The certificate is valid for one year and renewable for 3 years

Documents to Use

Application form

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The period of registration process is Three (3) months after submission of samples and a complete drug dossier for each pharmaceutical product to be registered.

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites. 	
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Samples and printed matter to be forwarded to the Board through the local agent; customs duty and clearance to be effected by the applicant in all instances.

Required Information

• Particulars of the product
• Particulars of the applicant
• Particulars of the local agent
• Particulars of the manufacturer
• Certification by a responsible person in the applicant company

Need for the Document

The registration of medical device by the Registrar of Pharmacy Board of Sierra Leone Central Medical Stores Compound ensures that all medical devices distributed, imported or exported in or out of Sierra Leone are of the benefit of the consumers

Information which might help

Enter other informations which might help.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

pharmacy board
Guide lines for medical products

Others

More information which might help people.