1. Regulation of Medical Devices: Tanzania experience Fimbo, A. M Tanzania Food and Drugs Authority

2. 2 Outline ► Background ► Key milestones in regulation of medical devices ► Implementation phases of regulation of medical devices ► Regulatory processes ► Evaluation and registration ► Control of importation ► GMP/QMS inspection ► Post marketing surveillance ► Lessons learnt & challenges ► Conclusion

3. Background ► TFDA - Executive Agency under the Ministry of Health and Social Welfare ► Established under the Tanzania Food, Drugs and Cosmetics Act No.1, 2003 ► TFDA Mission - Protect and promote public health by ensuring quality, safety and effectiveness of food, drugs, cosmetics and medical devices. ► Mandated under Section 5(1)(a) of the Tanzania Food, Drugs and Cosmetics Act, 2003 to regulate all matters relating to quality, safety and performance of medical devices including importation, manufacture, labeling, storage, promotion, sell and distribution of medical devices in the country.

4. Background……… ► Definition of medical device - 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; ► intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or animals or; ► intended to affect the structure or any function of the body of man or animals and which does not achieve any of its principal intended purposes through chemical action within the body of man or animals and which is not dependent upon being metabolized for the achievement of any of its principle intended purposes. ► (Section 3 of TFDA Act, 2003)

5. 5 Key Milestones ► 1999: Control of importation started under Pharmacy Board ► 2003: TFDA was established ► 2008: Department of Medical Devices Assessment and Enforcement created ► 2009-2010: Notification of all devices on the market started (3,500 devices notified) ► 2010: 1 st phase of registration started and still on going ► Up to 2012: 218 applications received (79 devices registered)

6. Implementation phases of regulation of medical devices 6 Phase IPhase IIPhase III Activities Control of importation of medical devices - Ongoing Development of guidelines: Registration of Devices Licensing of Premises Good Distribution Practices Post Marketing Surveillance Completed Activities Registration of medical devices – started and still ongoing Licensing of premises dealing with medical devices - Ongoing Advertisement and promotion control – Not yet started Activities Prohibition against unlicensed premises dealing with medical devices – Enforcement ongoing Prohibition against supply of unregistered medical devices – Partial enforcement has started for devices which have been registered

7. Evaluation and registration of devices (Done based on risk classification) ClassRisk LevelExamples ALow riskSurgical retractors/ tongue depressors BLow – moderate riskHypodermic Needles/ suction equipment CModerate – high riskLung ventilator/bone fixation plate DHigh riskHeart valves/ implantable defibrillator

8. Evaluation & registration of devices ► Some class A devices are exempted from registration ► All devices in class B, C and D require registration ► The evaluation process for registration of devices is done in two stages: ► Screening ► Evaluation

9. Evaluation & registration of devices ► All class B, C and D devices are evaluated after the screening stage before registration ► The evaluation process for Class A non exempted devices ends at screening stage

10. Evaluation & registration of devices ► Guidelines on Submission of Documentation for Registration of Medical Devices has been developed for applicants to follow through when compiling data for registration ► The registration guidance document has many elements of the Summary Technical Documentation (STED)

11. List of devices under 1 st phase of registration 1. Syringes 2. Surgical sutures 3. Examination & surgical gloves 4. Scalp vein set 5. Intravenous cannulae 6. Catheters and tubes 7. Condoms 8. Needles 9. Administration Sets (blood lancets and I.V giving sets) 10.Blood collection bags 11.Surgical dressings 12. Internal prosthetic replacements 13.Orthopaedic implants 14.Bone cements 15.Drug eluting stents and; 16.Intraocular lenses 11

12. Control of importation ► Receipt of application form and proforma invoice ► Devices must either be notified or registered (phase 1 devices) ► For unregistered devices Tanzania Bureau of Standards (TBS) CoA is used as a basis for approval

13. GMP/QMS Inspection ► Not done at the moment ► Considered during evaluation whereby manufacturers are required to comply with ISO 13485:2003 and ISO 9001:2008 ► Certificate needs to be submitted

14. Post Marketing Surveillance ► Guidelines on Post Marketing Surveillance of Medical Devices including In-vitro Diagnostic Devices have been developed ► PMS programme manual has also been developed ► Phase 1 plan is to collect samples of syringes, condoms and gloves from the market and test them at TFDA Lab

15. WHO Pilot Project on strengthening regulatory capacity of diagnostics and PMS ► Tanzania is one of 5 countries implementing the WHO pilot project ► Objectives ► Building and/or strengthening of national regulatory capacity and PMS of diagnostics ► Strengthening procurement and supply chain management of priority diagnostics ► Building and/or strengthening of National Health Laboratory Quality Assurance and Training Centre to carry on testing of diagnostic batches

16. WHO Pilot Project…. ► Through this project samples of IVD’s to include HIV test kits and malaria rapid diagnostic test kits (RDTs) will be collected from the market and tested ► This will ensure availability of quality diagnostics in Tanzania

17. Lessons learnt and Challenges ► Devices are many in numbers and of varying technologies and complexities ► Inadequate number of medical device laboratories within the region for performance evaluation is a challenge ► A stepwise approach in regulation of devices should be considered since devices vary in technologies and design ► Skilled regulatory experts in this area are few hence it is a rate limiting factor for regulation ► Few countries regulate devices in Africa ► Stakeholders involvement is crucial in setting up regulatory system for medical devices

18. Conclusion ► Capacity building for regulation of medical devices in developing countries should be prioritized by WHO. ► Countries should start to consider setting up policies, laws and regulations for control of devices to ensure that they are safe, of good quality and perform to standards. This will help protect and promote public health. ► A platform for exchange of regulatory information on medical devices should be established to enable better exchange of information e.g. biannual international conferences.