Medical Device Registration in
Algeria
Ministry of Health
The Ministry of Health, Population and Hospital Reform
Regulatory Authority
Directorate of Pharmacy – Direction de la Pharmacy et du Medicament (DPM)
National Laboratory of Control of Pharmaceutical Products (LNCPP)
Medical Device Regulation
Article 7 – Executive Decree No. 11-380 (dt. Nov. 21, 2011)
Official Language
Arabic and French
Classification
Class I, IIa, IIb and III
Medical Device Registration in Algeria
– Appoint a local Authorized Representative
– Prepare registration application
– Once approved, DPM will grant the product registration.
– Product can be marketed in Algeria
Documents Required
- Application Form
- Information on the Manufacturer and Distributor
- Declaration of Conformity
- CE Certificate or equivalent
- Product Information Documents:
– Instructions For Use
– Product description
– Details on biological product
– Risk Class
– Storage Conditions
– Device life cycle
– Device composition
– Device images
– Mechanism of Action
– Clinical Data
– Report on the Test Mode of the device
– Report on the manufacturing process
– Description of inspection on raw material
– Materials used in packaging
– Method of sterilization
– Indications, contraindications, Warnings
Post-market Requirements
Adverse events should be reported to DPM
Legalized/Notarised Documents (if any)
The documents may be sent to the Chamber of Commerce and the embassy for Legalization.
Applicable QMS
Registration Timeline
No defined registration timeline. Import License is issued in 30 days
Authorized Representative
Yes
License Validity
3 years
Special Notes
Documents can be either in French or Arabic. Labels & IFUs should be in French and Arabic