Allied Substances
The Allied Substances section is responsible for the regulation of medical devices, in-vitro diagnostic devices, disinfectants, and other allied health products. The Authority ensures that these products meet established standards for safety, quality, and performance before they are made available for use in Zambia.
This section conducts technical assessments, reviews product documentation, oversees registration processes, and monitors products throughout their lifecycle. Regular inspections and post-market surveillance activities help identify and address potential risks associated with allied substances.
By ensuring compliance with regulatory requirements, ZAMRA promotes access to reliable healthcare technologies that support quality healthcare delivery and patient safety.
- Application for Marketing Authorisation Condoms
- Temporary Guidelines for Hand Sanitizers
- Guidelines on the Principles of Medical Devices Classifications v1
- Guidelines on the Establishment of a Health Shop
- Guidelines for Label and Instructions For Use for Medical Devices
- Essential Principles of Safety and Performance of Medical Devices-v1
- Guidelines for grant of Marketing Authorisation of in vitro diagnostic devices for Human-use
- Application for Grant of Marketing Authorisation of In Vitro Diagnostic Devices for Human-v1
- List Item Guideline -for In vitro Diagnostic Medical Device Market Authorisation
- Guidelines on Renewal of Marketing Authorisation of Medicines and Allied Substances ZAMRA_2019v3
- Template for comments on Guidelines on Identification and Labelling of Medicines and Allied Substances and Master Data Sharing
- Guidelines on Recall of Medicines and Allied Substance
- Guildlines of Traceability of Medicines
- Medical Gloves Guidelines Final
- GUIDELINES ON APPLICATION FOR GRANT OF MARKETING AUTHORISATION OF NON IVDS