Unlocking Success: Navigating Medical Device Registration and Vigilant Post-Market Surveillance in Tanzania

Regulatory Authority

Tanzania Food and Drugs Authority / Tanzania Medicines and Medical Devices Authority (TMDA)

Tanzania Medicines and Medical Devices Authority (TMDA) is an Executive Agency under the Ministry of Health (MOH). TMDA which was formerly known as Tanzania Food and Drugs Authority (TFDA) was established in 2003 after enactment of the Tanzania Food, Drugs and Cosmetics Act, Cap 219 by the Parliament.

This Act was later amended in 2019 to Tanzania Medicines and Medical Devices Act, Cap 219 after the shift of responsibilities of regulating food and cosmetics to Tanzania Bureau of Standards (TBS). The change in legislative framework, which was done through the Finance Act, No. 8 of 2019 also resulted into the change of name to TMDA

TMDA is now responsible for regulating quality, safety and effectiveness of medicines, medical devices, diagnostics, biocidal and tobacco products. To improve public service delivery, TMDA is managed as an Executive Agency in accordance with the Executive Agencies Act, Cap. 245 which was also amended in 2009.

Link for Regulatory Authority

https://www.tmda.go.tz/

Local Regulation 

TMMD Act

Classification of Medical Devices

Class A, B, C and D

Listing or Registration Requirements

• An application consists of documentation in hard copies and electronic form, samples and fees. The applicant should have the following information before submitting the dossier to TFDA:

• Class of the device
• Intended purpose of the device
• GMDN code and term
• Conformity assessment certification
• Declaration of conformity
• When a device is found to have complied with all the prescribed registration requirements, the applicant will be informed of that effect. A certificate of registration together with such conditions as the TFDA may determine shall be issued. Registration of a device shall be site specific.

Documents Required for Tanzania Medical Device Registration

• Covering letter
• A duly filled in application form. Submission shall be both in hard copy and in electronic form on a CD-ROM
• A table of contents listing all sections of the dossier and documents and their corresponding page numbers
• Copies of referenced literature and other supporting documents
• Two samples of the commercial pack(s)
• A non-refundable application fee for registration of medical devices in Tanzania as provided in the Fees and Charges Regulations currently in force.
• Apply through the Tanzania Medicines and Medical Devices Authority (TMDA).
• Appoint a local authorized representative if you are a foreign manufacturer.
• Class A (Low-Risk) Devices:
• Basic Information:
  • Copies of labels for the device, primary/secondary components, and accessories.
  • Instructions for use.
  • Patient information leaflet (if applicable).
  • Sterilization validation report (for sterile devices).
  • Certification for measuring function (if applicable).
  • Certification for electrical safety (for active devices).
• Possible Exemption: Class A devices with low risk uses may be exempt from registration. Check the Second Schedule of the Regulations for details.
• Class B, C & D (Higher-Risk) Devices: Include all basic information required for Class A devices.
• Additional Information:
  • Description of the device, materials used, and features.
  • Intended uses and medical conditions it addresses.
  • Sales history in other countries and any reported issues.
  • Risk assessment plan.
  • Quality management plan.
  • Manufacturing process details.
  • Standards followed for design and manufacturing.
  • Summary of supporting studies (pre-clinical, clinical, etc.).
  • Biological safety evidence (if applicable for animal/human tissue).
  • Details on near-patient testing (if applicable).
  • Bibliography of relevant publications.
  • Copy of the quality management system certificate.

Registration Timeline

Once an application has been accepted and evaluation fees paid the processing of application:

• For Class A – 90 calendar days
• For Class B, C and D – 240 calendar days.

License Validity

5 Years

Post Market Surveillance

Manufacturers are reminded to submit biennial PMS report of the respective device including any adverse events as per requirement of The Tanzania Food, Drugs and Cosmetics Act.

Registration Fee

Domestic Devices

• Notification: 50,000 TZS, 5 days
• Registration:
  • Class A: 10,000 TZS, 20 days
  • Class B: 20,000 TZS, 20 days
  • Class C, D: 45,000 TZS, 45 days
• Variation:
  • Major: 150,000 TZS, 10 days
  • Minor: 10,000 TZS, 10 days
• Retention:
  • Registered devices: NA, NA
  • Notified devices: NA, NA

Imported Devices

• Notification: 100 TZS, 5 days
• Registration:
  • Class A: 500 TZS, 45 days
  • Class B: 2500 TZS, 45 days
  • Class C, D: 2500 TZS, 45 days
• Variation:
  • Major: 300 TZS, 10 days
  • Minor: 150 TZS, 10 days
• Retention:
  • Registered devices: 200 TZS
  • Notified devices: 50 TZS

Language Requirements

All applications and supporting documents shall be in Kiswahili or English

Who should make this Communication?

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk