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FOOD AND DRUGS AUTHORITY GHANA

Regional Center of Regulatory Excellence in Clinical Trials, Drug Registration and Pharmacovigilance
FDA's Laboratory is ISO/IEC 17025:2005 accredited in the field of Testing. Accredited by ANSI-ASQ National Accreditation Board/ANAB of USA and a member of ILAC

MEDICAL DEVICES DEPARTMENT

The Medical Devices Department (MDD) is of the two departments that make up the Medical Devices, Cosmetics and Household Chemical Substances (MDCHC) Division.

The Division is one of the new Divisions created to ensure improved efficiency in the work of the Food and Drugs Authority.It was created out of the then Drugs Division in March 2013.The Division has two Departments, namely the Medical Devices Department and the Cosmetics and Household Chemical Substances Department.

 

The Medical Devices Department 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, both foreign and locally manufactured.

SCOPE OF WORK


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.

 

STRUCTURE OF THE DEPARTMENT


The medical Devices Department is made up of two Units.The effective regulation of medical devices is premised on risk assessment and management.  Consequently, medical devices are classified based on the level of risk associated with their use.  There are four classes, with Class I being the lowest risk and Class IV being the highest risk.


UNIT


This Unit is responsible for the regulation of all medical devices in Class I.  Activities include:

  • Receipt of all applications for the registration and re-registration of medical devices in Class I.
  • Evaluation and processing of all applications received.
  • Management of the relevant data on clients and products.
  • Initiating, coordinating and carrying out appropriate research for the enhancement of regulation of medical devices in Classes I.
  • Initiate and coordinate meetings with stakeholders.
  • Initiate and coordinate training programmes for stakeholders.

 

UNIT II

This Unit is responsible for the regulation of all medical devices in Classes II, III and IV.  Activities include:

  • Receipt of all applications for the registration and re-registration of medical devices in Classes II, III and IV.
  • Evaluation and processing of all applications received.
  • Management of the relevant data on clients and products.
  • Initiating, coordinating and carrying out appropriate research for the enhancement of regulation of medical devices in Classes II, III and IV.
  • Initiate and coordinate meetings with stakeholders.
  • Initiate and coordinate training programmes for stakeholders.

 

STAFF
The current staff in the Department have varied expertise and experience.  These include pharmacy and botany.

 

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