Certificates and Licences

Certificates and licences held by us with respect to our quality and safety standards like ISO 9001, ISO 13485, USFDA, Europe/CE, UK/MHRA, Brazil/ANVISA, Colombia/INVIMA, Costa Rican, Mexico, CDSCO, and Vietnam/DMEC. With all the legal and technical documents certificates and licences can be given on loan.

1. ISO: In medical devices, International Organization for Standardization is the perfect standard that represents the requirements for a comprehensive management system than an ISO that complies with the Medical Device Directives.
2. USFDA: United States Food and Drug Administration is responsible for improving public health. They ensure the safety, efficiency, and affordability of medical products.
3. Europe/CE: Europe’s Conformité Européenne (CE) marking signifies that the product is examined by a notified conformity assessment body and follows all rules accordingly. Regarding safety, health, and environmental protection.
4. UK/MHRA: United Kingdom’s Medicines and Healthcare Products Regulatory Agency ensures that medical devices are effective and safe to use and meet the required quality and regulatory standards.
5. Brazil/ANVISA: Brazil’s Agência Nacional de Vigilância Sanitária is a Brazilian Health Regulatory Agency that eliminates risk medical devices and promotes health awareness.
6. Colombia/INVIMA: Colombia’s Instituto Nacional de Vigilancia de Medicamentos y Alimentos is a Colombia National Food and Drug Surveillance Institute which verifies that manufacturers have conditioning and storage conditions (for importers of medical devices), and issues health registrations.
7. Costa Rica: This is responsible for regulating the healthcare industry in Costa Rica. Also, the regulatory agencies for food, drugs, chemicals, and medical devices, ensure these products are up to standards.
8. Mexico: Mexico’s Ministry of Health is responsible for improving public health. They ensure the safety, efficiency, and affordability of medical products.
9. CDSCO: Central Drugs Standard Control Organisation for establishing standards for drugs, cosmetics, and medical devices. Also Verifying regulatory measures, legislative amendments, and rules. To authorize the marketing of new drugs and to regulate clinical trials in India.
10. Vietnam/DMEC: Vietnam’s Department of Medical Equipment and Construction is to regulate overall Medical Devices in the country under different Circulars.