European Conformity — EU MDR
The CE Mark confirms that Medinova Endosys products conform to the European Medical Device Regulation (EU MDR). This allows our products to be sold and distributed across all EU member states and recognised markets worldwide.
EU MDR Compliant
International Quality Management
ISO 13485 is the international standard for quality management systems in medical device manufacturing. It demonstrates our ability to consistently provide medical devices that meet customer and regulatory requirements.
Quality Management System
Drug Controller General of India
Approval from the Drug Controller General of India — the highest medical device regulatory authority in India. Our products are registered and approved for manufacturing and sale across India.
Indian FDA
Central Drugs Standard Control Organisation
Registration with CDSCO — the national regulatory body of India for medical devices under the Ministry of Health and Family Welfare. This registration is mandatory for all medical device manufacturers operating in India.
Govt. of India
Good Manufacturing Practice
GMP certification ensures our manufacturing processes, facilities, equipment, and personnel consistently meet quality standards. Every batch of products is made under controlled, validated conditions.
Manufacturing Excellence
Additional compliance
Medinova Endosys continuously works toward additional international certifications. Contact us for the latest compliance documentation for specific markets or regulatory requirements.
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