Wikiprocedure > Nigeria


Nigeria - Register a Medical Device

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Procedure[edit]

  • Registering for a medical Device is a complicated process and most companies find it beneficial to engage a local agent to take care of the bureaucratic procedures and any communication issues.
  • Fill up the application form.
  • Submit form along with all the required documents.
  • Once your application is approved you will received a Certificate evidencing registration of the medical device.
  • An applicant for a manufacturer outside Nigeria must file evidence of Power of Attorney from the manufacture which authorizes him to speak for his principal on all matters relating to the latters specialties. The original Power of Attorney is to be notarized in the country of origin by a Notary Public and submitted to NAFDAC Or Contract Manufacturing Agreement (where applicable). This should be notarized in the country of origin by a Notary Public and submitted to NAFDAC.



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Required Documents[edit]

  • Proof of ISO quality system certification (for sterile products)
  • Certificate of Free Sale.
  • Description and intended use of your medical device.
  • Declaration of Conformity certificate
  • Clinical data, test reports, and other data to support the safety and efficacy of the device, as required by the law in Nigeria.



Office Locations & Contacts[edit]

FEDERAL MINISTRY OF HEALTH AND SOCIAL SERVICES

Block 4A (301-399), 3rd Floor

New Fed. Secretariat Complex, Shehu Shagari Way,

P.M.B. 83, (Garki Post Office), Abuja

Tel: 09-5234590 .


New Federal Secretariat Complex, Phase III,

Ahmadu Bello Way, Central Business District,

PMB 083 Garki, Abuja

Nigeria


Telephone: +234 9 523 8362

Fax: +234 9 523 4590

Website: http://www.health.gov.ng



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Eligibility[edit]

  • To be able to register for medical device you must be:
  • A manufacturer of medical device in Nigeria.
  • If you manufacturer outside Nigeria you must appoint an authorized Representative.



Fees[edit]

The required fees for the document is 5000 Naira.



Validity[edit]

Valid for 1 year and a renewal is required every end of the year.



Documents to Use[edit]

Please attach documents that can be used by people. e.g. links



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Sample Documents[edit]

Please attach sample completed documents that would help other people.



Processing Time[edit]

It is process within 2 weeks.



Related Videos[edit]

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". 
	



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Instructions[edit]

Applications are filed at the Pharmaceutical Council of Nigeria.- Register at the Federal ministry of Health in Nigeria.



Required Information[edit]

  • The importation and manufacturing of the medical device.
  • Information on the usage of the medical device
  • The expiry date of the medical device
  • The information concerning the medical or IVD device manufacturer.
  • The Comprehensive service on the medical device that results in the successful registration.



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Need for the Document[edit]

Registration and approval of medical devices in Nigeria is done by Pharmaceutical Council of Nigeria , a division of the Nigerian Federal Ministry of Health that oversees the countrys medical device market. Through the Drug Policy and Planning Center (DPPC) and the Central Administration of Pharmaceutical Affairs (CAPA).

The Pharmaceutical Council of Nigeria also controls the importation and manufacturing of the medical devices and instruments through a specialized committee that comprises of leading professors with specialties in various medical fields, along with experts of medical engineering. Medical device manufacturers with no local presence in Nigeria are also required to appoint an authorized representative known as Nigerian Registration Holder (NRH) to interact with regulators on their behalf.



Information which might help[edit]

NOTE

The representative in Nigeria, whether a corporate body or an individual with the power of attorney, will be held responsible for ensuring that the competent authority in the country is informed of any serious hazard newly associated with a product imported under the provisions of the Act or of any criminal abuse of the certificate in particular to the importation of falsely labeled, spurious, counterfeited or sub- standard medicinal products.



Other uses of the Document/Certificate[edit]

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



External Links[edit]

http://www.nafdac.gov.ng

http://www.nigeria.gov.ng/2012-10-29-11-06-51/executive-branch/98-federal-ministry-of-health/170-federal-ministry-of-health

http://apps.who.int/medicinedocs/documents/s17115e/s17115e.pdf


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Others[edit]

More information which might help people.