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First Global Forum on Medical Devices

Bangkok-Thailand, September 9 - 11 2010

Regulatory Control of Medical Devices in Tanzania

Mr. Hiiti SilloAg. Director General

Tanzania Food and Drugs Authorityhiiti@yahoo.com/hiiti.sillo@tfda.or.tz

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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

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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

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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;

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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

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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)

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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

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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

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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

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Guidance Documents

• Finalized (www.tfda.or.tz)

– Guidelines on Submission of Documentation for Registration of Medical Devices BUT excludes diagnostics

• Drafts published for comments (www.tfda.or.tz)

– Guidelines for Application Permit to Deal with Business of Medical Devices

– Guidelines for Good Distribution Practice of Medical Devices

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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

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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

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Phase I Devices …

9. Administration Sets (Blood giving and taking sets, blood lancents and I.V giving sets)

10.Blood collection bags11.Surgical dressing12. Internal prosthetics replacements13.Orthopaedic implants14.Bone cements15.Drug eluting stents and;16.Intraocular lenses

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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 starts16

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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

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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

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Abbreviations

• GHTF – Global Harmonization Task Force

• GMDN – Global Medical Devices

Nomenclature

• STED – Summary Technical Documentation

• UMDNS – Universal Medical Devices

Nomenclature System

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Thank youThank youThank youThank you