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ISO 13485 QMS
ISO 13485 certification
Ensure your products are certified securely from start to finish with Consulting from GXP WAY for ISO 13485 certification.
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Conform ” Meet global requirements. “
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Sure “Increase effectiveness and patient safety. “
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Quickly ” Accelerate market and product launches. “
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With hardly any other product does quality have such a direct impact on the efficacy and safety of patients, users and possibly others as with medical devices.
Therefore, many national regulations require manufacturers and suppliers of medical devices to prove that they have a quality management system in place. This quality management system is audited and certified by an independent body.
If manufacturers or suppliers do not have a certified quality management system, it is usually more difficult for their products to be approved in the large, important markets. Delays in market entry and loss of sales can be the result.
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In the European Union, the requirements of EN ISO 13485 have been harmonised with the requirements of the EU Medical Devices Directive (93/42/EEC), the In Vitro Diagnostic Medical Devices Directive (98/79/EC) and the Active Implantable Medical Devices Directive (90/385/EEC).
Certification according to EN ISO 13485 by an accredited certification body automatically leads to a presumption of conformity. Accordingly, a manufacturer certified to EN ISO 13485 is presumed to comply with the aspects of the requirements of these directives covered by the standard.
advantages of ISO
The advantages of ISO 13485 at a glance.
- Certification enables improved access to global markets
- Examinations are described and processes optimised
- Efficiency is increased, costs are reduced and monitoring of supply chain performance is improved.
- The medical devices manufactured are safer and more effective
- Customer expectations and requirements from the directives (MDD, IVDD and AIMD) are met
Regulatory Authority:
Egyptian Drug Authority (EDA)
Classification:
I, IIa, IIb, III, IV
Quality system:
ISO 13485:2016
Procedure:
All medical devices must be registered with CAPA (Central Administration of Pharmaceutical Affairs) and obtain the Marketing Authorization.
Manufacturers with no local presence in Egypt must appoint an Egyptian Registration Holder.
Applicant:
Egypt Registration Holder (ERH)
Timeframe and fees:
At least 5 months
Validity:
10 years
Labeling and documentation language:
Home use labeling must be provided in Arabic and professional use labeling must be provided in English.