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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.
Kosher Certification – Product & Facility Compliance
CERAMAT Private Limited is certified by Kosher Certification Jerusalem (KCJ), confirming that its manufacturing facility and specified products operate under Orthodox Rabbinical supervision and comply with the Laws of Kashrut.
Certified products are designated as Strictly Kosher – Pareve (non-Passover), indicating suitability for use in food, oral care, nutraceutical, and other regulated applications requiring Kosher compliance.
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. Kosher certification applies to the facility and listed products operating under Rabbinical supervision in accordance with Kashrut regulations. Compliance for other grades or formulations may vary and can be confirmed upon request.