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Certifications & Regulatory Compliance
Quality system certification and regulatory compliance supporting medical, dental and consumer-care hydroxyapatite materials.
ISO 13485:2016 – Quality Management System
CERAMAT Private Limited has implemented and maintains a Quality Management System (QMS) certified to ISO 13485:2016, the internationally recognized standard for medical device quality management systems.
The certification is issued by Zenith Quality Assessors Pvt. Ltd., an NABCB-accredited certification body, and covers the design and development, manufacture, and sale of raw materials used for coating of implantable medical devices, specifically Thermal Spray Grade Hydroxyapatite.
This certification demonstrates CERAMAT’s commitment to regulatory compliance, product consistency, risk-based quality controls and continual improvement in support of global medical device manufacturers.
REACH (SVHC) Compliance – European Union
Based on laboratory testing conducted by SGS India Pvt. Ltd., the tested Hydroxyapatite grade meets the requirements of the current SVHC candidate list (250 substances) published by the European Chemicals Agency (ECHA) as of June 25, 2025.
This assessment supports the suitability of CERAMAT’s material for use in regulated and export-oriented applications within the European Union.
Scope of Compliance:
ISO 13485:2016 certification applies to CERAMAT’s quality management system and defined manufacturing scope.
REACH (SVHC) compliance statements are based on laboratory testing of specific product grades and samples. Compliance for other grades or formulations may vary and can be confirmed upon request.