Ghana - Registration of Medical Device or in vitro diagnostics devices (IVDs)

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Procedure

How to apply :
In person :

1. Applicant should visit the Food and Drug Authority regional office near you, approach the services desk and request for the application form for the class you are applying for or download it from the link below: Application form for Class 1 and Application form class II-IV
2. Fill in the application form accurately and attach the requirement and submit them to the attending officer
3. Your application will be verified, evaluated, processed and inspection of the premises will be done by The Medical Devices Department (MDD) committee elected by the Food and Drugs Authority (FDA).
4. If all the information are in order and the application fees paid, you will be issued with the licences within 6 months

NOTE:
If the applicant is not satisfied with the decision of the Authority, the applicant may make representations to the Authority within sixty days after the date of the notification;

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Required Documents

• Documentation/Dossier
• Samples
• Prove of receipt for payment Fees
• Accurately filled application form

Office Locations & Contacts

FOOD AND DRUGS AUTHORITY

Eligibility

• foreign and locally manufactures

Fees

Fees

Validity

The licences is valid for 5 years

Documents to Use

Application form for Class I
Application form class II-IV

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• Within 6 months ,if all the information are in order

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

• A manufacturer shall ensure that the medical device meets the safety and effectiveness requirements.
• A manufacturer shall keep objective evidence to establish that the medical device meets the requirements.

Required Information

The label of the medical device shall have a labelling information which shall be in English and shall be expressed in a manner which is legible, permanent and in a prominent manner, and which can be easily understood by the intended user The labelling information shall include the following

• Should state the proprietary product of the medical device or IVDs
• The name and address of the manufacturer
• The manufacturing site address
• The manufacture should state the medical devices system, test kit, medical device group, medical device family or medical device group family
• In the case of a Class III or IV device, the control number, otherwise the batch or lot number
• An indication of what the package contains, expressed in terms appropriate to the device, such as size, net weight, length, volume or number of units
• The word “Sterile” if the manufacturer intends to sell the device in a sterile condition
• The words “for single use only” ,if the device is intended for that purpose
• The expiry date of the device expressed in day, month and year
• The medical conditions, purposes and uses for which the device is manufactured, sold or represented, including the performance specifications of the device if those specifications are necessary for proper use unless self-evident to the intended user
• The directions for use should be indicated, unless directions are not required for the safe and effective use of the medical device or IVDs.
• warnings, precautions and limitations of product
• Any special storage conditions applicable to the device
• The labelling design shall not bear close resemblance to other products, which are already registered by the Authority.

Need for the Document

The Medical Devices Department (MDD) is responsible for the regulation of all classes of medical devices in Ghana and thus undertakes the evaluation of applications and registration of medical devices, in foreign and locally manufactured.

Information which might help

Specifically, the MDD is responsible for:

• The development of guidelines and requirements for the registration of all classes of medical devices.
• Evaluation of all documentation for the registration and re-registration of medical devices
• Development of the appropriate administrative and evaluation tools to ensure that all medical devices are appropriately labeled and pose minimal risks to both users and operators.
• Monitoring the safety of all medical devices for the purposes of effective classification.
• Ensuring that all manufacturers and importers of medical devices in Ghana are licensed.
• Dissemination of current product information on medical devices.
• Monitoring international regulations and assess the impact of any changes and their impact on the regulation of medical devices in Ghana.
• Liaising with other Departments to undertake the inspection of manufacturing facilities for medical devices.
• Liaising with other Departments for the post-market monitoring of medical devices.

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

FOOD AND DRUGS AUTHORITY Guide lines
Implementation of medical devices

Others

More information which might help people.