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

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Procedure

Regulation of Medical Devices in Algeria is conducted by the Directorate of Pharmacy - Direction de la Pharmacy et du Medicament (DPM) and by the National Laboratory for the Control of Pharmaceutical Products (LNCPP), which are under the supervision of the Ministry of Health and Population (MOHP). Registration documents must be submitted to both bodies.
How to apply:

1. Applicant should appoint a local authorized representative (LAR) in Algeria and visit the Directorate of Pharmacy - Direction de la Pharmacy et du Medicament (DPM) and the National Laboratory for the Control of Pharmaceutical Products (LNCPP) with the requirements
2. Approach the services desk and request for assistance, fill in all the required application form accurately ,attach all the requirements and submit them to the attending official
3. Your application will be evaluated and processed by the medical committee appointed by the DMP
4. If all the information is in order and the application fees paid, you will be issued with the licences by the DMP register

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Required Documents

• Accurately filled Application form
• Information on distributor and LAR
• Declaration of Conformity
• CE or its equivalent
• Manufacturing information
• Product information
• 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 must be translated in either Arabic or French .

Office Locations & Contacts

Le Directeur de La Pharmacie et du Medicament:
125 Rue Laala Abderrahmane Alger. Algeria
Tel: 21321279628
Fax: 2132179184
Fax: 2132179184
Email: [email protected]

Laboratoire National de Contrôle 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)

Eligibility

• Local and foreign manufactures

Fees

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

Validity

• Licences is valid for 3 years

Documents to Use

homologation

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• No official registration timeline. Import licences issued in 30 days

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

• Registration of Medical Devices for sale in Algeria requires approval from the Ministry of Health and Population (MOHP). Additionally, all documentation submitted to Algeria regulators must be translated into either French or Arabic language.
• Regulation of Medical Devices in Algeria is conducted by the Directorate of Pharmacy and by the National Laboratory for the Control of Pharmaceutical Products (LNCPP), which are under the supervision of the Ministry of Health and Population. Registration documents must be submitted to both bodies
• The medical devices labelling language requirement should be either in Arabic or French

Required Information

Information on the product documents required as follows:

• Instruction for use
• Label
• Product description
• Details on the biological product
• Risk class
• Storage conditions
• Device life cycle
• Device composition
• Device images
• Mechanism of action
• Indications, contraindications, warnings
• Method of sterilization
• The material used in the packaging
• Description of the inspections made on raw materials
• Report on the manufacturing process;
• Report on the test made on the device
• Clinical data

Need for the Document

The objective of registration of medical device by the Directorate of Pharmacy and by the National Laboratory for the Control of Pharmaceutical Products (LNCPP), 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

Information which might help

Enter other informations which might help.

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

Ministry of Health and Population
More information from Ministry of Health and Population

Others

More information which might help people.