Registration of medical devices 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.

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

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: info@pharmacyboard.gov.sl
Website: Testing and reserach
Email: registration@pharmacyboard.gov.sl
Regional Offices- Bo, Kenema, Makeni and Kono.Ads by Google

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

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.

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

External Links

pharmacy board
Guide lines for medical products