Cameroon - Registration of Medical Devices or In Vitro Devices (IVDs).

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Procedure

The Medical Devices Department (MDD) division under FOODS AND DRUGS AUTHORITY is responsible for the regulation of all classes of medical devices in Cameroon and thus undertakes the evaluation of applications and registration of medical devices,in foreign and locally manufactured.
How to apply:

1. Applicants should gather all the required documents and visit the foods and drugs authority, office in charge is the medical devices department (MDD)
2. Approach the services desk and request for the application form or download it from the Direction de la pharmacie du medicament et des laboratories (DPML Application form
3. Fill the form accurately ,attach the required documents and submit it to the attending official
4. Your application will be reviewed, evaluated, processed by the MDD committee
5. If all the information are in order and the application fees paid, you will be issued with the licences by the register

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Required Documents

• Accurately filled application form
• Sample of the product (if applicable)
• Documentation/Dossier
• Bank deposit slip (prove of payment)

Office Locations & Contacts

Direction de la pharmacie du medicament et des laboratories (DPML):
Address: in Mballa 2 near the Jamot hospital in Yaounde
Phone: + (237) 222-21-92-81
E-mail: [email protected]
Website: DPML

FOODS AND DRUGS AUTORITY :
Head Office: PO BOX 411300, RUE MARIE GOCKER, YAOUNDE, CAMEROON
Email: [email protected]
[email protected]
00237 655485794, 00237 650990546
Website: Food and drugs

Eligibility

• Local and foreign manufactures

Fees

Explain the fees structure which is required for obtaining the certificate/document.

Validity

• The licences is valid for 5 years and renewable afterwards

Documents to Use

Application form

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

Please explain processing time taken in obtaining the document/certificate.

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites. 	
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

There Two Units who’s responsibility is to regulate all medical devices. Unit 1 deals with class I only while Unit 2 deals with Classes II, III and IV. Activities include:

• Receipt of all applications for the registration and re-registration of medical devices
• Evaluation and processing of all applications received.
• Management of the relevant data on clients and products.
• Initiating, coordinating and carrying out appropriate research for the enhancement of regulation of medical devices
• Initiate and coordinate meetings with stakeholders.
• Initiate and coordinate training programs for stakeholders.

Required Information

• Proprietary/brand name
• Brief description of the device
• Category of the device
• Intended use and method of use
• Medical specialty in which the device is used
• Contraindications, warnings, precautions, potential adverse events
• List of accessories and other devices or equipment to be used in combination with the device.
• Variations in shape, style or size of the device, if applicable
• Labelling details
• Packaging description including pack sizes
• Recommended storage conditions
• Address of the applicant/premises of storage

Need for the Document

The objective of registration of medical device by The Medical Devices Department (MDD) is to protect patients and the general public by ensuring that all medicinal products circulating in the country are

• Safe
• Efficacious
• Of good quality
• Suitable/appropriate to the local market
• Therapeutically relevant to the health needs of the population (for community health diseases)

Information which might help

The Medical Devices Department (MDD) is responsible:

• The development of guidelines and requirements for the registration of all classes of medical devices.
• Evaluation of all documentation for the registration and re-registration of medical devices
• Development of the appropriate administrative and evaluation tools to ensure that all medical devices are appropriately labeled and pose minimal risks to users and operators.
• Monitoring the safety of all medical devices for the purposes of effective classification.
• Ensuring that all manufacturers and importers of medical devices in Cameroon are licensed.
• Dissemination of current product information on medical devices.
• Monitoring international regulations and assess the impact of any changes and their impact on the regulation of medical devices in Cameroon.
• Liaising with other Departments to undertake the inspection of manufacturing facilities for medical devices.
• Liaising with other Departments for the post-market monitoring of medical devices.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

DPML
foods and drugs authority

Others

More information which might help people.