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
Registration Process
– 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
ISO 13485:2016
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