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Ghana Medical Device Regulation

Ghana Medical Device Regulation

Unlocking Growth: Navigating Ghana’s Medical Device Market with FDA Compliance and Regulatory Excellence

Updated on 26/01/24

Regulatory Authority: Ghana FDA (Food and Drug Authority) The Food and Drugs Authority (FDA) in Ghana is dedicated to ensuring the integrity of food and products, meeting the growing demand for quality consumption. Established in 1992, the FDA is recognized by the World Health Organization and other international regulatory bodies. With over 27 years of service in various industries, the FDA maintains acute standards for systems, processes, and products in the socio-business and medical environment.

The FDA Ghana aims to provide updated information on food, medicines, cosmetics, household chemicals, tobacco, medical devices, biological products, and vaccine safety.

The agency’s five cardinal points include product evaluation, licensing and accreditation, capacity building, safety inspection and monitoring, and public education and sensitization.

Link for Regulatory Authority:http://www.fdaghana.gov.gh/

Local Regulation:Public Health Act, 2012, Act 851

Classification:ClassI, II, III, and IV

Listing or Registration Requirements:Full registration required

Documents Required:
  1. General Requirements
  • Cover letter
  • Power of Attorney
  • Device details
  • Name
  • description, category
  • Intended use, Contraindications, Warnings, Precautions
  • Adverse events
  • Alternative use
  • Storage conditions
  • Shelf life (where applicable)
  1. Summary of TD
  • Evidence of Conformity to Essential principles
  • Materials
  • Device Specifications
  • Device Verification and Validation
  • Biocompatibility (if applicable)
  • Software Verification and Validation (if applicable)
  • Devices Containing Biological Material (if applicable)
  • Pre-clinical Studies (if applicable)
  • Clinical Evidence (if applicable)
  • Risk Analysis
  • Manufacturing Information
Registration Timeline:6 months

Registration Fee:
  1. Imported Medical Devices (per annum)
  • Class I: USD 60
  • Class II: USD 100
  • Class III/IV: USD 160
  1. Local Medical Devices (per annum) – USD 250
License Validity and Renewal:3 years. It must be renewed before 3 months of expiry date

Special Labelling Requirements:The labelling information shall include the following:
  • the name of the device, both „proprietary‟ and „common‟
  • the name and address of the manufacturer; the manufacturing site address
  • the identifier of the device, including the identifier of a device that is part of asystem, test kit, medical device group, medical device family or medical devicegroup familyin the case of a Class III or IV device, the control number, otherwise the batch orlot number
  • an indication of what the package contains, expressed in terms appropriate to thedevice, such as size, net weight, length, volume, or number of units
  • the word “Sterile” if the manufacturer intends to sell the device in a sterilecondition
  • 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 thosespecifications are necessary for proper use unless self-evident to the intended userthe directions for use, unless directions are not required for the safe and effective
  • use of the device.
  • 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 already registered by the Authority.
Who should make this communication:
  • Manufacturer
  • Authorized Representative
When to make this communication: Before placing a medical device into the market.

Market Overview: The projected revenue in Ghana’s medical devices market is anticipated to reach $138 million in 2023. Additional analyses suggest that the medical device market in Ghana has the potential for substantial growth, potentially doubling in size if certain favorable conditions are realized. Several factors, such as governmental policies, advancements in healthcare infrastructure, technological progress, and the rising demand for healthcare, play pivotal roles in determining the extent of this growth. Notably, heightened investments by both the government and private sector in healthcare, coupled with the establishment of new facilities that necessitate advanced equipment, emerge as key contributors to this significant growth potential.

How OMC Medical can assist you with the process
  • Act as your Authorized representative
Why Choose Us
  • Working towards client satisfaction
  • Cost effective solutions
  • Project completion before deadline
  • Quality Regulatory affairs solutions
Contact us for free consultation: [email protected]
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