How To Registration of Medical Devices or In Vitro Devices (IVDs). In Algeria
Regulation of medical Devices for use in Algeria is managed in the Directorate of Pharmacy – Direction de la Pharmacy et du Medicament (DPM) and the National Laboratory for the Control of Pharmaceutical Products (LNCPP) and is under the control under the supervision of the Ministry of Health and Population (MOHP). The registration documents have to be submitted to both of the bodies. How to apply:
- The applicant should designate an authorized representative local (LAR) to Algeria and then visit to the Directorate of Pharmacy – Direction de la Pharmacy et du Medicament (DPM) as well as the National Laboratory for the Control of Pharmaceutical Products (LNCPP) in accordance with the regulations
- Contact the desk at the front of the line and ask for assistance. complete the application forms accurately, attach all the required information and send them to the official in charge.
- The application you submit will be assessed and handled by the medical committee selected by the DMP
- If all the details are correct and the application fees have been paid and the application fees have been paid, you will be issued with the licenses from the DMP register.
Documents that are required Registration of Medical Devices or In Vitro Devices (IVDs)
- Form that is accurately filled in
- Information about distributors and the LAR
- of Conformity of Conformity
- CE and its equivalent
- Information on manufacturing
- Information about the product
- Instruction, label, description, risk class, clinical data, device composition, method of sterilization and mechanism of action (if applicable),warnings, materials in packing ,clinical data.
Note:
All documents need to be translated into either Arabic as well as French .
Office Locations and Contacts
Le Directeur de La Pharmacie et du Medicament:
125 Rue Laala Abderrahmane Alger. Algeria
Tel: 21321279628
Fax: 2132179184
Fax: 2132179184
Email: msdphm@ibnsina.anda.dz
Laboratoire National de Controle des Produits Pharmaceutiques (LNCPP)
Address: Lot Geraud petit staouali, Dely Brahim, Alger, Algerie
Phone: +213 21 37 32 42
Director General de la Phamacie et des Equipements Medicaux:
Minister de l sante de la population et de la Reforme Hospitaliere
125,Boulevard Abderrahmane Laala
El Mouradia Alger. Algeriae
Tel: 21279628
Fax: 21279184
Ministry of Health and Population (MOHP)
What Are All The Eligibility
- Manufacturers from the local and abroad
Validity
- The licence is valid for three years.
Documents to Utilize
Processing Time
- There is no official registration deadline. Import permits issued in 30 days
Instructions
- The registration of medical Devices to be sold for sale in Algeria is subject to approval by MOHP. Ministry of Health and Population (MOHP). In addition, all documentation that is provided to Algeria regulators has to be translated into French or Arabic language.
- Regulation of medical Devices for use in Algeria is managed through the Directorate of Pharmacy and by the National Laboratory for the Control of Pharmaceutical Products (LNCPP) and is under the control under the supervision of the Ministry of Health and Population. Documents for registration must be sent to both organizations.
- The language used to label medical devices is required to be either Arabic or French
The Information You Need
The information on the product documentation is needed to be provided as follows:
- Instructions for using
- Label
- Product description
- Information on the bioproduct
- Risk class
- Conditions of storage
- Life-cycle of the device
- Composition of devices
- Images from devices
- Mechanism of action
- Warnings, contraindications, and indications
- Methods of sterilization
- The material that is used in packaging
- The description of inspections performed on the raw materials
- A report about the process of manufacturing
- The report on the test performed using the device
- Clinical data
Need to have the Document
The goal of the registration of medical devices through the Directorate of Pharmacy and by the National Laboratory for the Control of Pharmaceutical Products (LNCPP) in order to safeguard patients and the general population in ensuring pharmaceutical products that are available in the country are registered.
- Secure
- Efficacious
- Of good quality
- Affordable to the market in the local area
External Links
Ministry of Health and Population
More details on the Ministry of Health and Population