Algeria IVDD Registration Requirements in English

X

xgg810116

#1
Could anyone help me on IVDD registration in Algeria? I could not read French, so I now only get a little information about it:

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 both under the supervision of the Ministry of Health and Population. Registration documents must be submitted to both bodies.
The classification system is similar to the EU system (Class I, IIa, IIb and III), but the CE mark or FDA clearance are not mandatory for submission.
A local representative must be assigned for the registration process.

Could anyone help me confirm whether the abovementioned information is right?

Could anyone give me the website of the Directorate of Pharmacy and the National Laboratory for the Control of Pharmaceutical Products (LNCPP)? Or give me the detailed regulations in Algeria?

Thanks in advance!:thanks:
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
L Medical Device Regulations in Morocco, Algeria, Tunisia Other Medical Device Regulations World-Wide 2
I Regulations in the Magrheb countries Morocco, Lybia, Algeria, Tunisia and Mauritania Other Medical Device Regulations World-Wide 2
S Medical Device Registration requirements for Algeria and Libya ISO 13485:2016 - Medical Device Quality Management Systems 3
L IVDD/IVDR vs 13485 Matrix EU Medical Device Regulations 0
E Technical documentation for IVDD General/ other CE Marking (Conformité Européene) / CB Scheme 3
H Re-labelling in IVDD - Re-label two products and package them as one CE Marking (Conformité Européene) / CB Scheme 5
B EU: Alcohol test kits for breast milk IVDD EU Medical Device Regulations 2
JoshuaFroud The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status CE Marking (Conformité Européene) / CB Scheme 1
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
M Informational Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) Medical Device and FDA Regulations and Standards News 5
P IVDD - IFU related requirements - Type of information/statement expected EU Medical Device Regulations 1
L IVD Reagent Techncial File Review Requirements (IVDD Annex III) EU Medical Device Regulations 4
C IVDD 98/79/EC Measuring Function Requirements EU Medical Device Regulations 2
L IVDD 98/79/EEC - Can I self declare? EU Medical Device Regulations 2
P Proposed Changes to the Medical Device Directive (and IVDD) EU Medical Device Regulations 0
M IVDD ER 8.3 Vs. Hazard Labelling Regulations - Which outranks? EU Medical Device Regulations 2
W New harmonised standards MDD and IVDD 2012/C 262 EU Medical Device Regulations 4
D IVDD RoHS Directive Compliance to 2011/65/EU RoHS, REACH, ELV, IMDS and Restricted Substances 4
R No Stability Standard on latest List of Harmonized Standards IVDD ISO 13485:2016 - Medical Device Quality Management Systems 2
I IVDD - Software and Graphics Standards or Guidance Documents EU Medical Device Regulations 3
W New Harmonized Standards MDD and IVDD EU Medical Device Regulations 5
W EN ISO 13485:2003 harmonized to AIMD, MDD and IVDD ISO 13485:2016 - Medical Device Quality Management Systems 2
S Third party accessory registration and labelling Other US Medical Device Regulations 4
J Device notification / registration with competent authority EU Medical Device Regulations 2
A Anxiety - ISO Re-registration Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 69
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 1
C European Technical File for registration in Australia CE Marking (Conformité Européene) / CB Scheme 5
W MDD Distributor Registration Requirements Other Medical Device Regulations World-Wide 0
N Actor registration EUDAMED restricted: got no Email to complete the registration EU Medical Device Regulations 5
K FDA Registration and listing weird situation Medical Device and FDA Regulations and Standards News 4
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
H Medical device Product Registration Registrars and Notified Bodies 2
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1
B Health Canada - Blood Glucose Meter Registration Canada Medical Device Regulations 0
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
Q Is Establishment Registration Necessary? Other US Medical Device Regulations 1
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
J IVD registration renewal in China China Medical Device Regulations 6
JoCam Registration of other manufacturers devices UK Medical Device Regulations 3
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 2
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 7
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 6
M Establishment Registration US Food and Drug Administration (FDA) 3
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
A Registration requirements for custom branded device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1

Similar threads

Top Bottom