How To Registration of Medical Devices or In Vitro Devices (IVDs) In Cameroon

How To Registration of Medical Devices or In Vitro Devices (IVDs) In Cameroon

The Medical Devices Department (MDD) division of FOODS and DRUGS AUTHORITY is accountable for the oversight of all types of medical equipment in Cameroon and, consequently, the assessment of applications and the registration of medical devices that are foreign or locally made.

What is the procedure to use it?:

  • Candidates should have all necessary documents and go to the food and drugs authority. The head of the office is department of medical devices (MDD)
  • Go to the service desk and ask for the application form . You can also take it off the direction of the Pharmacy du Drug and des laboratoires (DPML Application form
  • The form should be filled in accurately, then attach the necessary documents and send it to the official who will be attending
  • It will then be evaluated, reviewed and processed and approved by the MDD committee.
  • If all the required information is in order , and all application fees are paid and the application fees have been paid, the applicant will then be issued the licenses issued by the register.

Documents that are required Registration of Medical Devices or In Vitro Devices

  • Completely filled out application form
  • The product’s sample (if it is applicable)
  • Documentation/Dossier
  • Deposit slip from the bank (prove of the payment)

Office Locations and 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: info@dpml.cm
Web site: DPML
Foods and Drugs Autority:
Head Office Head Office: PO BOX 411300 RUE MARIE GCKER, CAMEROON, YAOUNDE
Email: fdacameroonreg@gmail.com
info@fdacameroon.com
00237 655485794, 00237 650990546
Site: Food and drugs

What Are All TheEligibility

Foreign and local manufacturers

Validity

  • The license lasts for five years, and is renewable following that time.

Send us your documents

Application form

Instructions

Two Units whose responsibility is to oversee the medical devices of all kinds. Unit 1 deals with Class I and Unit 2 is responsible for Classes II, III , and IV. The activities include:

  • Receipt of all application forms to register and re-register of medical devices
  • Processing and evaluation of all applications that are received.
  • Control of the relevant data regarding clients and products.
  • Coordinating, initiating and carrying relevant research to development of regulations for medical devices
  • Set up and organize meetings with key stakeholders.
  • Create and coordinate training programmes for the stakeholders.

The Information You Need

  • Brand name or trademark owned by the brand
  • An overview of the device.
  • Device’s Category
  • The intended use and the method of usage
  • Medical specialty where the device is utilized
  • Warnings, contraindications, and precautions and possible adverse reactions
  • The list below includes accessories and other equipment or devices to be used with the device.
  • Style, shape or the size of the device, if applicable.
  • Labelling details
  • Packaging description including pack sizes
  • Storage conditions that are recommended
  • Address of the applicant/premises for storage

The Document is required Registration of Medical Devices or In Vitro Devices

The purpose of registering a medical devices with The Medical Devices Department (MDD) is to safeguard patients as well as the general population in ensuring medical products that are available in the country are registered.

  • Secure
  • Efficacious
  • Of good quality
  • The product is suitable for the local market
  • Health needs of the general population (for illnesses of the community)

Information that can be useful

  • The Medical Devices Department (MDD) is responsiblefor:
  • The creation of guidelines and registration requirements for all medical devices.
  • Examining all documentation needed to allow registration and re-registration for medical devices
  • Design of the proper tools for evaluation and administration to ensure that medical devices are properly marked and pose no risks to the users and operators.
  • The monitoring of the security of all medical devices for the purpose of ensuring an effective classification.
  • ensuring that all manufacturers as well as importers and distributors of medical equipment in Cameroon are certified.
  • Information dissemination of the latest information regarding medical devices.
  • Examining international regulations and assessing the effect of any changes , as well as their effect regarding the regulations for medical equipment in Cameroon.
  • Working with other Departments to conduct the inspection of manufacturing facilities that manufacture medical devices.
  • Collaboration with other departments to monitor post-market compliance of medical devices.

External Links

DPML
Food and Drugs Authority

Source

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