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
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 Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
G ITAR Registration for Metrology Laboratory? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
A 510(k) registration and listing US Food and Drug Administration (FDA) 1
A GMDN Registration Basic preliminary Information EU Medical Device Regulations 0
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
P Establishment Registration and Device listing - Wording of 807.20 (a) (6) Medical Device and FDA Regulations and Standards News 3
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
O Cancellation of Registration from ARTG - Sponsor Unresponsive Other Medical Device Regulations World-Wide 0
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
T Reaction Plan To Drive suppliers to IATF 16949 registration IATF 16949 - Automotive Quality Systems Standard 4
N Post registration variation to medical device Other Medical Device Regulations World-Wide 1
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
MDD_QNA Medical Device registration Argentina Other Medical Device Regulations World-Wide 0
A In which EU countries would it be okay to use sample labels for registration? EU Medical Device Regulations 0
D EUDAMED Single Registration Number (SRN) - How to get it? EU Medical Device Regulations 8
M Informational ANVISA – CONSULTA PÚBLICA No 730, DE 14 DE OUTUBRO DE 2019 – Registro de dispositivos médicos (Public consultation – registration of medical devices) Medical Device and FDA Regulations and Standards News 0
F FDA-registration and inspection cost 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J FDA Establishment Registration Foreign Manufacturer RUO only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Change in BRH (Brazilian Registration Holder) Technical Manager Other Medical Device Regulations World-Wide 2
C FDA Registration Requirements for Multiple Sites 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M Setting deadlines (ex. 45 days) for Document Registration & Review Cycle Document Control Systems, Procedures, Forms and Templates 3
S Private Label Requirements, Manufacturer's Registration & Initial Importers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
F 2017/745 Article 31 Single Registration Number Medical Device and FDA Regulations and Standards News 5
S FDA Registration food facility - We operate under CGMP guidelines US Food and Drug Administration (FDA) 0
C Can a manufacturer (in South of Korea) have multiple Brazil Registration Holder (BRH) for same brend name? Other Medical Device Regulations World-Wide 1
S Which department manages Establishment Registration, Device Listing and GUDID? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom