Marketing Authorization
PROCEDURES FOR MARKETING AUTHORIZATION OF MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC DEVICES IN TANZANIA BY TANZANIA MEDICINE AND MEDICAL DEVICES AUTHORITY (TMDA)

PROCEDURES FOR MARKETING AUTHORIZATION OF MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC DEVICES IN TANZANIA BY TANZANIA MEDICINE AND MEDICAL DEVICES AUTHORITY (TMDA)

What is Market Authorization:

An official approval of the medicinal product to be marketed or distributed in a respective country.

What is Market Authorization Holder (MAH):

In other name called “APPLICANT” simply means a person or Company who/which submits an application for registration of a medicine, an update or amendment to an existing registration to the Authority who may be a manufacturer or a person to whose order and specifications, the product is manufactured. After the product is registered the applicant shall be “marketing authorization holder”

Authorization Procedures:

There are two authorization procedures that a company may use to obtain a marketing authorization for a medical product depending on the consent of the company.

A: National procedure

B: Harmonization and Collaborative procedures

A: National Procedure:

Under this procedure there are two ways of getting Market Authorization (MA) which depends on the risk associated with the Medical Device (MD) or Invitro Diagnosis (IVDs).

  1. By Notification
  2. By Registration

Determination in which way the applicant should use to attain MA for the Medical product will rely on the classification of that Medical Product. This classification is according to the risk resulting from the use of the device, and in-vitro diagnostics according to the risk associated with the implications of the results they produce either to the individual or public.

Medical devices:

ClassRisk LevelDevice Examples
ALow RiskSurgical retractors / tongue depressors
BLow-moderate RiskHypodermic Needles / suction equipment
CModerate-high RiskLung ventilator / bone fixation plate
DHigh RiskHeart valves / implantable defibrillator

In-vitro diagnostic devices;

ClassRisk LevelDevice Examples
ALow Individual Risk and Low Public Health RiskSpecimen Receptacles, prepared selective culture media
BModerate Individual Risk and/or Low Public Health RiskVitamin B12, Pregnancy self-testing,Anti-Nuclear Antibody, Urine test strips
CHigh Individual Risk and/or Moderate Public Health RiskBlood glucose self-testing, HLA typing,PSA screening, Rubella, Malaria
DHigh Individual Risk and High Public Health RiskHIV Blood donor screening, HIV Blood diagnostic

NOTE: These classifications are based on international practices and are in line with the rules of the Global Harmonization Task Force (GHTF) and can be accessed in the official website of TMDA www.tmda.go.tz in Guidelines on Submission of Documentation for Registration of Medical Devices, third edition, April 2020  in Annex III and Guidelines on submission of Documentation for Registration of In-vitro Diagnostic Devices, third edition, April 2020 in Annex II.

  1. BY NOTIFICATION.

The selected Class A devices will attain market approval through notification and the list of Class A Medical Devices and IVDs eligible in this category can be found in Guidelines on Submission of Documentation for Registration of Medical Devices, third edition, April 2020 and Guidelines on submission of Documentation for Registration of In-vitro Diagnostic Devices, third edition, April 2020 in TMDA official website.

Requirements:

At minimum the Applicant should submit the following;

  • Description of the device including features, accessories, intended uses and users.
  • 3D pictorial presentation of the device with all sides of the device clearly visible.
  • Product label in line with Section four (4) of the guidelines and symbols according to ISO 15223-1.
  • Evidence of Certificate of Compliance to ISO 13485 of the manufacturer(s).
  • Certificate of analysis (if applicable) e.g masks, sanitary pads, diapers etc.
  • Two (2) product samples in their commercial park.
  1. BY REGISTRATION

In this category it involves below mentioned stages

POST REGISTRATION PROCEDURES:

The validity of the registered product is five (5) years, after which it’s subject for renewal. For changes related to any registered medical devices and In-vitro diagnostic devices, the Market Authorization Holder must lodge a variation application.

  1. Authorization of Variations

After a MD or IVDs has been authorized, the terms of the marketing authorization may subsequently be varied. The procedures around such variations are governed by Tanzania Medicines and Medical Devices (Registration of Medical Devices and IVDs) Regulations and Guidelines on Submission of Application for Change(s) to Approved Medical Devices and In-Vitro Diagnostics, First Edition, 2022 all of which are available on the TMDA website.

Process Flow:

  1. Renewal applications

Marketing authorizations are valid for five years from the date of first issue. For the authorization to remain valid, it should be renewed at the end of this five-year period.

Renewal applications should be submitted to TMDA at least three (3) months before the expiry of the authorization, although earlier renewals are acceptable to facilitate a common renewal date for a range of products. Renewal applications should be accompanied by the Application form for renewal of a marketing authorization, and this should be done according to the Regulation and guideline.

Process Flow:

WITHDRAWAL OF MARKETING AUTHORIZATION:

Withdrawal of an authorization or certificate may occur during the period of validity of the authorization or certificate or during the renewal when marketing authorization holder (MAH) decides not to renew it or for any reason. In each case, the Authority should be notified of the intention to withdraw.

This withdrawal can be classified into two:

i.             Voluntary withdrawal

ii.           Mandatory withdrawal

  1. Voluntary withdrawal (withdrawal initiated by marketing authorization holder):

Holder must initiate the withdrawal of authorization through TMDA trader portal by attaching an official letter which should indicate the       reason  for withdrawal, which can be commercial or may relate to concerns regarding the quality, safety or effectiveness of the product.

  1. Mandatory withdrawal (withdrawal initiated by the Authority)

Withdrawal of an authorization or certificate may occur during the period of validity of the authorization or certificate when the MAH contravened the regulations or any provision of the Act or any reason relate to concerns regarding the quality (including GMP status in case of Class C and D), safety        or effectiveness of the product the registration of the products shall be withdrawn, suspended or revoked.

B: HARMONIZATION AND COLLABORATIVE PROCEDURE:

World Health Organization (WHO) Collaborative Registration Procedure (CRP)

This is a voluntary procedure whereby an applicant agrees to share with TMDA the assessment reports developed during WHO – prequalification. It is a collaboration between TMDA and WHO in the effort to reduce duplication of work and to ensure timely accessibility of products.

TMDA participates in the WHO prequalification Collaborative Procedures for Accelerated registration of IVDs (CRP) and Emergency Use Listing procedures – Facilitated procedure (EUL – FP) for both emergency and routine authorization of medical devices and IVDs of WHO prequalified and Listed In Vitro. Diagnostics.

Areas of CRP reliance

  • Dossier assessment
  • Performance evaluation
  • GMP inspection of the manufacturing site
  • Approval of changes

Who can apply?

An applicant of an IVDD which has been pre-qualified by WHO

How to apply?

  1. Applicants should voluntarily express interest in applying the procedure for accelerated registration of their prequalified products by filling the WHO expression of interest form (Appendix 3);
  2. Applicants should authorize WHO to share its assessment and inspection outcomes for the specific product(s), with TMDA by filling the WHO consent form (Appendix 2);
  3. An applicant must submit the same dossier to TMDA as the one approved by WHO for prequalification, along with TMDA application form for registration and Appendix 3 form;
  4. Requirements for TMDA online submission and fees for registration of in-vitro diagnostic devices remain the same.

Flow chart for the MA to NRAs under WHO-CRP

Flow chart of Authorization of changes to the product followed WHO-CRP

Flow Chart for withdrawal, Suspension or Delisting MA to the product followed WHO-CRP

Importance of WHO – CRP.

Shortens registration process by:

  • Utilizing available resources and reduce duplication of efforts
  • Waiving in country performance evaluation of the IVDD
  • Conducting desk review of manufacturing facility in lieu of physical quality audit of the site

NOTE: On how to Apply and other technical support you can consult

www.petalitepharma.com

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