Medical Devices, Cosmetics & Household Chemical Substance

About FDA The Division’s mandate derived from Part 7 of the Public Health Act 2012, Act 851, is to protect public health by ensuring the availability of safe, effective and quality medical devices, cosmetics, and household chemical substances on the Ghanaian market. The key regulatory functions of the MDCHCD includes product registration, premises registration and post approval market surveillance of these products. The MDCHC achieves its mandate through the following Departments:i. Medical Devices Departmentii. Cosmetics and Household Chemical Substances Departmentiii. MDCHC Inspectorate Departmentiv. MDCHC Market Surveillance DepartmentMEDICAL DEVICES DEPARTMENT (MDD)The Mandate of the Medical Devices Department is defined by the following Sections of part 7 of the Public Health Act, 2012, Act 851;*Section 118 Registration medical devices*Section 119 Cancellation or suspension of registration*Section 147 (1) – (3) Regulations*Part 7 Section 148 (1)-(4) Guidelines and Codes of Practice.Scope of MandateThe department processes and grants market authorisation for medical devices intended for export and/or sale on the Ghanaian market.Operational ActivitiesThe operational activities of the department are as follows:i. Processing and approvals for new, renewal and variation applications.ii. Participation in product registration meetingsiii. Dossier evaluationiv. Maintain the medical devices registerv. Correspondence with applicantsvi. Issuance of registration certificatesvii. Revocation of registration certificatesviii. Coordination of TAC Meetings on medical devicesix. Coordination of site testing of medical devicesx. Registration of importers of medical devices.xi. Drafting of billsxii. Drafting and review of guidelines and codes of practiceThe Department has two operational units; the Evaluation and Registration of Low Risk Medical Devices Unit and Evaluation and Registration of High Risk Medical Devices Unit.COSMETICS AND HOUSEHOLD CHEMICAL SUBSTANCES DEPARTMENT (CHCD)The Mandate of the Cosmetics and Household Chemical Substances Department is defined by the following Sections of part 7 of the Public Health Act, 2012, Act 851;*Section 118 Registration cosmetics and household chemical substances*Section 119 Cancellation or suspension of registration*Section 147 (1) – (3) Regulations*Part 7 Section 148 (1)-(4) Guidelines and Codes of Practice.Scope of MandateThe department processes and grants market authorisation for cosmetics and household chemical substances intended for export and/or sale on the Ghanaian market.Operational ActivitiesThe operational activities for the department are as follows:i. Processing and approvals for new, renewal and variation applications.ii. Participation in product registration meetingsiii. Maintain the cosmetics and household chemical substances registersiv. Correspondence with applicantsv. Issuance of registration certificatesvi. Revocation of registration certificatesvii. Registration of importers of cosmetics and household chemical substances.viii. Drafting of billsix. Drafting and review of guidelines and codes of practiceThe Department has two operational units; the Cosmetics Unit, and Household Chemical Substances Unit.MDCHC MARKET SURVEILLANCE DEPARTMENT (MSD)The Mandate of the MDCHC Market Surveillance Department is defined by the following Sections of part 7 of the Public Health Act, 2012, Act 851;*Sections 111 Prohibited sale of medical devices, cosmetics, household chemical substances.*Sections 112 Standards*Sections 113 Deception of consumers*Sections 118 Registration of medical devices, cosmetics, household chemical substances.,*Sections 119 Cancellation or suspension of registration*Section 114 Prohibited advertisement*Section 123 (1) Counterfeit medical devices, cosmetics, household chemical substances,*Section 132 (1)(2)(3) Closure of premises and safe disposal of unwholesome regulated products*Section 135 Powers of authorised officers*Section 147. (1)-(3) Regulations*Section 148. (1)-(3) Guidelines and codes of practice.Scope of MandateThe department undertakes post registration market surveillance operations for medical devices, cosmetics and household chemical substances.Operational ActivitiesThe operational activities for the department are as follows:i. Post registration product quality monitoring to ensure safety and quality has not been varied.ii. Monitoring the recall of non-conforming products from trade.iii. Retail outlet inspections/raids/swoops to detect and rid the market of non-conforming products.iv. Consumer complaints investigations into suspected product quality defects and substandard and falsified medicinal products.v. Advertisement vetting, approval, monitoring and enforcement.vi. Supervision of safe disposal of non-conforming products.vii. Detention of non-conforming products.viii. Inspection of non-conforming products detained by Import Export Control Department.ix. Drafting of bills.x. Drafting and review of guidelines and codes of practice.The Department has three operational units; the Retail Market Surveillance Unit, Product Verification Unit and Quality Monitoring and Supervision Unit. Divisions Food Drug Registration & Inspection Safety Monitoring & Clinical Trials Medical Devices, Cosmetics And Household Chemical Substance Monitoring & Evaluation