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Algeria

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

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

Registration Timeline

No defined registration timeline. Import License is issued in 30 days

Documents Required

  1. Application Form
  2. Information on the Manufacturer and Distributor
  3. Declaration of Conformity
  4. CE Certificate or equivalent
  5. 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

 

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