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Registration of medical devices or in vitro devices (IVDs) in Sierra Leone. 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.
What are in vitro diagnostic medical devices? In vitro diagnostic medical devices (IVD) are tests used on biological samples (such as tissues, blood or urine) to determine the status of a person’s health.
How to apply :
- 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.
- If the applicant is a foreign company, it shall appoint a local agent through whom an application shall be submitted.
- The local agent shall be a registered Pharmaceutical Importation Company or an accredited manufacturer’s representative registered as a pharmacist in Sierra Leone.
- 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
- 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.
- 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
Registration of medical devices or in vitro devices (IVDs) in Sierra Leone
- 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
- 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
Pharmacy Board of Sierra Leone Central Medical Stores Compound
New England Ville, Jomo Kenyatta Road, Freetown
Phone: (+232 22) 228497, 225983, 229346
Fax: (+232 22) 224526
Website: Testing and reserach
Regional Offices- Bo, Kenema, Makeni and Kono.
Local and foreign manufactures
- The certificate is valid for one year and renewable for 3 years
Documents to Use
- 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.
- 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
Guide lines for medical products