Certified for Global Standards.
Trusted for Quality.
Our cleanroom manufacturing environments, sterilization cycles, and sterile medical devices comply with international directives including ISO 13485:2016, ISO 9001:2015, WHO-GMP, and European CE certification.
Medical Devices Quality Management System
Certified for the design, development, manufacture and distribution of sterile medical devices including infusion sets, blood transfusion sets, catheters, and flow regulators.
Quality Management Systems Certification
Comprehensive quality assurance standard governing manufacturing processes, continuous improvement, and strict traceability across all operational units.
Good Manufacturing Practices Certificate
Official WHO-GMP compliance certificate validating Class 10,000 / Class 100,000 cleanroom manufacturing, sterilization integrity, and contamination control.
European Conformity Certification
CE Mark compliance attestation verifying European health, safety, and environmental protection standards for sterile single-use disposable medical devices.
CE Certified Product Scope Schedule
Detailed European product certification annex encompassing IV Infusion Sets, Dial Flow Regulators, Extension Sets, and Blood Administration Sets.
Drug & Medical Device Manufacturing Licence
Official statutory manufacturing licence for commercial production and domestic/export supply of sterile disposable medical devices.
Market Standing Certificate
Official governmental confirmation of continuous active commercial manufacturing and flawless market supply without any product failure or recall.
Non-Conviction & Good Standing Certificate
Certifies an unblemished regulatory record, full adherence to all national statutory healthcare guidelines, and complete compliance across operations.
Performance & Quality Verification Certificate
Endorsement validating exemplary product efficacy, batch-to-batch consistency, and clinical reliability delivered to major hospitals and healthcare networks.
Need a Copy of Our Full Compliance Dossier?
Connect with Mecca Healthcare to request institutional audit dossiers, batch test certificates, or discuss specialized regulatory requirements.
Contact Compliance Team →