Understanding Medical Device Registration in Zambia

Overview on Medical Device Market

Zambia’s health care system is developing, providing diagnostic and curative medical services. The country has received over $5 billion in U.S. government assistance since 2004, primarily through the President’s Emergency Plan for AIDS Relief (PEPFAR), to scale up integrated prevention, care, and treatment programs for HIV epidemic control. Over 1.1 million Zambians now receive life-saving antiretroviral treatment, and the HIV incidence rate has been cut in half over the last decade.

HIV prevalence is high in Zambia, with 14% of the adult population HIV positive, with higher rates in urban areas. Zambia lacks sufficient hospital centres for specialized treatment and specialist diagnostic centres for cancer, cardiovascular, liver, or renal diseases.

Opportunities exist for investment in specialist medical diagnostic and treatment in areas such as cardiology, radiotherapy, neurology, urology, trauma, nephrology, diabetology, dermatology, physiotherapy, keyhole surgery, stem cell therapy, and other surgical interventions.

Regulatory Authority

Zambia Medicines Regulatory Authority(ZAMRA)

 The Zambia Medicines Regulatory Authority formally the Pharmaceutical Regulatory Authority is a Statutory National Medicines Regulatory Body in Zambia established under an Act of Parliament, the Medicines, and Allied Substances Act No. 3 of 2013 of the Laws of Zambia to regulate and control the Manufacture, Importation, Storage, Distribution, Supply, Sale and Use of Medicines and Allied Substances. 

The main objective of the Authority is to ensure that all Medicines and Allied Substances being made available to the Zambian people consistently meet the set standards of Quality, Safety and Efficacy.

Link for Regulatory Authority

https://www.zamra.co.zm/

Classification of Medical Devices

• Class A
• Class B
• Class C
• Class D

Documents Required for Zambia Medical Device Registration

• • Application Form
  • STED Product Dossier
  • Essential Principles of Safety and Performance
  • Labelling & packaging
  • Quality documentation

License Validity

5 years

Special Labelling Requirements 

Labelling should be done in English.

Who should make this Communication?

• Manufacturer
• Authorized Representative
  

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the Process?

• Act as your Authorized representative

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