Medical Devices and Allied Substances

Medical Devices and Allied Substances are regulated to ensure they meet the required standards of safety, quality, and performance before they are manufactured, imported, distributed, sold, or used within the country. Effective regulation protects patients, healthcare professionals, and the public while supporting access to safe and reliable healthcare technologies.

Medical devices include instruments, apparatus, machines, implants, diagnostic equipment, and software intended for medical purposes such as diagnosis, prevention, monitoring, treatment, or alleviation of disease. Allied substances include healthcare-related products that require regulatory oversight to ensure their safety, quality, and intended use.

The regulatory authority oversees the registration, licensing, importation, exportation, distribution, and post-market surveillance of these products to ensure compliance with national legislation and internationally recognized standards.

Medical Devices

Medical devices may include:

• Diagnostic equipment

• Surgical instruments

• Hospital and laboratory equipment

• Medical implants

• In-vitro diagnostic (IVD) devices

• Medical software and digital health technologies

• Disposable medical supplies and consumables

Allied Substances

Allied substances may include:

• Disinfectants and antiseptics

• Medical gases

• Diagnostic reagents

• Laboratory chemicals and reagents

• Healthcare consumables

• Other regulated healthcare-related substances as prescribed by law

Regulatory Requirements

Manufacturers, importers, distributors, wholesalers, and retailers are required to:

• Obtain the necessary licences and permits.

• Register products where applicable.

• Ensure products comply with established quality, safety, and performance standards.

• Maintain proper storage, transportation, and distribution conditions.

• Keep records to support product traceability.

• Report product defects, adverse events, or safety concerns to the regulatory authority.

• Comply with routine inspections and post-market surveillance activities.

Regulatory Oversight

The Authority is responsible for:

• Evaluating and registering medical devices and allied substances.

• Licensing manufacturers, importers, exporters, distributors, and retailers.

• Inspecting regulated premises for compliance.

• Monitoring product quality, safety, and performance throughout their lifecycle.

• Investigating complaints, adverse events, and product defects.

• Taking regulatory action against counterfeit, substandard, falsified, or unauthorized products.

• Promoting compliance through guidance, education, and stakeholder engagement.

By regulating Medical Devices and Allied Substances, the Authority helps ensure that healthcare providers and the public have access to safe, effective, high-quality, and reliable products that support quality healthcare delivery and protect public health.