First Global Forum on Medical Devices Bangkok-Thailand, September 9-11 2010 Regulatory Control of Medical Devices in Tanzania Mr. Hiiti Sillo Ag. Director General Tanzania Food and Drugs Authority hiiti@yahoo.com/hiiti.sillo@tfda.or.tz 1
Talking points 1. Background 2. Regulatory Framework 3. Roadmap for implementation 4. Medical devices Registration 5. Where are we today? 6. Challenges 7. Key Recommendations 2
Tanzania Food and Drugs Authority (TFDA) Executive Agency under the Ministry of Health and Social Welfare Established under the Tanzania Food, Drugs and Cosmetics Act No.1, 2003 Mandate - Regulate quality, safety and effectiveness of food, medicines, cosmetics and medical devices Mission - protect and promote public health by ensuring quality, safety and effectiveness of food, drugs, cosmetics and medical devices. Vision - become the best regulatory authority in regulating food, drugs, cosmetics and medical devices in Africa by 2015 3
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Regulatory Framework Section 5(1)(a) of the Tanzania Food, Drugs and Cosmetics Act No.1, 2003 Mandates TFDA to regulate all matters relating to safety and performance of medical devices importation, manufacture, labelling, marking and identification, storage, promotion, sell and distribution of medical devices in the country. Definition: An instrument, apparatus, implement, medical equipment, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is recognized in the Official National Formulary, or Pharmacopoeia or any supplement to them; 6
Regulatory Framework (2) Definition.. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals or; intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its principal intended purposes through chemical action within the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principle intended purposes. NOTE: the harmonized definition for medical devices as defined by GHTF will be adapted soon 7
Roadmap to Implementation 1999: Started control of importation 2003: TFDA was formed 2008: Department of Medical Devices Assessment and Enforcement formed 2009: Notification of all devices on the market (3,500 devices notified) 2010: Phase I Registration kick-starts(36 appl. rced) 8
Roadmap The Process TFDA adopted Classification Rules promulgated by GHTF Devices are classified into classes A, B, C and D The registration guidance document has many elements of the STED Registration to be done in phases Key stakeholders involved in each stage 9
Roadmap... Implementation phases Phase I Phase II (Partial Implementation) Phase III (Full Implementation) (i)control of importation of medical devices (ii)finalization of guidelines for registration/licensing of devices and establishments Activation of duties and obligations to dealers Registration of medical devices Licensing of parties dealing with medical devices Advertisement and promotion control Prohibition against unlicenced parties dealing with medical devices Prohibition against supply of unregistred medical devices Impact on supply of medical devices No restriction on the supply of medical devices Supply of unregistered medical devices is prohibited 10
Impact on dealers of medical devices (a)no restriction on manufacturing, import and wholesale of medical devices (b)duties and obligations imposed Submission of documents and testing reports upon TFDA request Mandatory reporting of product defects and adverse events Mandatory notification of product recall Obligation to keep records Mandatory product recall upon TFDA instructions Unlicenced manufacturing, importation and wholesaling of medical devices is prohibited 11
Guidance Documents Finalized () Guidelines on Submission of Documentation for Registration of Medical Devices BUT excludes diagnostics Drafts published for comments () Guidelines for Application Permit to Deal with Business of Medical Devices Guidelines for Good Distribution Practice of Medical Devices 12
Framework for Registration Registration approach is based on level of risk of the device Two stages: Screening & Evaluation Some Class A devices are exempted from registration All Devices in Class B, C and D require registration All class B, C and D devices will be evaluated after the screening stage before registration 13
Phase I devices 1. Syringes 2. Surgical sutures 3. Examination and surgical gloves 4. Scalp vein set 5. Intravenous cannulae 6. Catheters and tubes 7. Condoms 8. Needles 14
Phase I Devices 9. Administration Sets (Blood giving and taking sets, blood lancents and I.V giving sets) 10.Blood collection bags 11.Surgical dressing 12. Internal prosthetics replacements 13.Orthopaedic implants 14.Bone cements 15.Drug eluting stents and; 16.Intraocular lenses 15
WHO Project on strengthening regulatory and PMS capacity for diagnostics in resource-limited settings 2009-2012 Objectives Building and/or strengthening of national regulatory capacity for diagnostics Strengthening procurement and supply chain management of priority diagnostics Building and/or strengthening of National Health Laboratory Quality assurance and Training Centre capacity for post market surveillance of diagnostics Situation analysis of the regulatory capacity for diagnostics and PMS activities in Tanzania, 2009 Actions Plans now in final stage before implementation starts 16
Challenges in regulating medical devices Existence of multiple nomenclature system for medical devices i.e. GMDN, UMDNS,. TFDA adopted GMDN Lack of adequate expertise within TFDA Capacity building is critical Lack reference documents i.e. Packaging of medical devices Lack of regulatory systems in neighboring African countries 17
Key Recommendations to WHO Provide platform for exchange of regulatory information on medical devices e.g. databases, biannual international conferences Provide capacity building for regulatory control of MD to African Regulators Support establishment of Post marketing surveillance and adverse events monitoring systems 18
Abbreviations GHTF Global Harmonization Task Force GMDN Global Medical Devices Nomenclature STED Summary Technical Documentation UMDNS Universal Medical Devices Nomenclature System 19
Thank you 20