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Certifications & Regulatory Compliance
Quality system certification and regulatory compliance for hydroxyapatite materials across medical, dental, oral care and consumer applications.
ISO 13485
REACH
Kosher Certified
ISO 16128
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.
ISO 16128 – Ingredient Classification Standard
CERAMAT Private Limited complies with ISO 16128-1:2016 and ISO 16128-2:2017, which provide guidelines for the classification and evaluation of ingredients based on their origin and composition.
These standards are widely used across the cosmetic, oral care, and personal care industries, and support transparency in identifying natural, derived natural, and synthetic materials.
The certification covers calcium phosphate-based bioceramic materials manufactured through controlled chemical synthesis, with applications across cosmetic, oral care, biomedical, and medical device-related sectors.
Scope of Compliance:
ISO 13485:2016 certification applies to CERAMAT’s quality management system and defined manufacturing scope for medical device-related materials.
REACH (SVHC) compliance statements are based on laboratory testing of specific product grades and samples in accordance with applicable European regulations.
Kosher certification applies to the facility and listed products operating under Rabbinical supervision in accordance with Kashrut regulations.
ISO 16128 certification applies to ingredient classification and evaluation based on origin and composition for cosmetic, oral care and related applications.
Compliance applicability for specific grades or formulations may vary and can be confirmed upon request.