- info@omcmedical.co.uk
Get In Touch:
Get In Touch:
- info@omcmedical.co.uk
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
- 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
Want to know more about this registration process?
Quick Contact
If you have any questions or need help, feel free to contact with our team.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Quick Contact
If you have any questions or need help, feel free to contact with our team.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Quick contact
- info@omcmedical.co.uk
-
0044 7719761764
0044 2080667260 - Planet House, North Heath Lane, Horsham, West Sussex RH12 5QE
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
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