Cameroon Medical Device Regulation

“Comprehensive Guide to Medical Device Regulation in Cameroon: FDA, Registration Process, and Market Overview”

Regulatory Authority

FDA Cameroon

The Medical Devices Department (MDD) is part of the Medical Devices, Cosmetics and Household Chemical Substances (MDCHC) Division, created in March 2013 to improve the Food and Drugs Authority’s efficiency. It is responsible for regulating all classes of medical devices in Cameroon, evaluating applications, and registering both foreign and locally manufactured devices.

The MDD’s scope of work includes developing guidelines and requirements for device registration, evaluating documentation, developing administrative tools for proper labeling, monitoring device safety, ensuring licensing for manufacturers and importers, disseminating product information, monitoring international regulations, collaborating with other departments for inspection of manufacturing facilities, and post-market monitoring of medical devices. The department also ensures that all manufacturers and importers of medical devices in Cameroon are licensed.

Link for Regulatory Authority

https://fdacameroon.com/division/the-medical-devices-department

Classification of Medical Device

Class I, II, III, IV

Documents Required for Registration

1. Filled application form

2. Sample of the product (if applicable)

3. Documentation/Dossier

4. Bank deposit slip (prove of payment)

Technical Documentation must include

1. Proprietary/brand name

2. Brief description of the device

3. Category of the device

4. Intended use and method of use

5. Medical specialty in which the device is used

6. Contraindications, warnings, precautions, potential adverse events

7. List of accessories and other devices or equipment to be used in combination with the device.

8. Variations in shape, style, or size of the device, if applicable

9. Labelling details

10. Packaging description including pack size

11. Recommended storage conditions

12. Address of the applicant/premises of storage

TimeFrame for Registering New Product

The official timeline for registering a new product is 90 business days.

License Validity

5 Years

LICENSE TRANSFER

The possibility of transferring a license exists, although there is currently no defined procedure or regulation in place.

Who should make this Communication?

1. Manufacturer

2. Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

CAMEROON MEDICAL DEVICES MARKET OVERVIEW

Cameroon’s medical devices market, though currently smaller in scale compared to its regional counterparts, exhibits significant growth potential. With a population surpassing 27 million and a burgeoning middle class, the demand for high-quality healthcare and advanced medical technology is on a consistent upward trajectory.

Anticipated regulatory changes, particularly in consumer data protection, such as the General Data Protection Regulation (GDPR) of the European Union, are expected to lead to increased costs associated with the development of new products and the delivery of patient services. Additionally, modifications in equipment approval processes are projected to contribute to elevated operational expenses.

Investments in the development of new products are facing challenges, as the potential for income loss due to product release delays and additional expenses incurred in navigating stringent regulatory processes adds pressure. These factors collectively impact the expansion of the medical devices and equipment market.

Despite its current size, the medical device market in Cameroon is poised for growth, fueled by increasing healthcare awareness, government initiatives, and endeavors to enhance healthcare infrastructure. Both public and private entities contribute to the healthcare sector in Cameroon, with the government actively encouraging private sector involvement in healthcare delivery and the provision of medical devices. This collaborative approach aims to foster a more robust and accessible healthcare system in the country.

How OMC Medical can assist you with the process?

Act as your Authorized representative

Why Choose Us?

1. Working towards client satisfaction

2. Cost effective solutions

3. Project completion before deadline

4. Quality Regulatory affairs solutions