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ISO 13485:2016 & Indian FDA
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Brand of India

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In October 2005 The Central Govt. of India issued a notification S. O. No.1468(E) dtd. 6th Oct - 2005 wide which The Orthopaedic Implants had been covered under Drugs & Cosmetics Act 1940. These notified devices are to be manufactured by only valid Medical Devices Mfg. License holders approved by CDSCO, India. We took very early steps to fulfil the regulatory requirements by setting up all new state of the art manufacturing unit at Vadodara in 2007.

The company successfully complied with the standards laid down by The Indian FDA and got the manufacturing Drugs License in form-28 on 26th June, 2009 jumping among early top five companies of India and later complying with New MDR 2017 MD-9 License for Sterile and Non Sterile Implants. Our manufacturing unit is equipped with all modern manufacturing facilities. The manufacturing activities are carried out under ISO 13485:2016 standards and strict supervision of technically competent persons and management. Our vision is to offer quality products at affordable rates with unbeaten service back up.

Ortho Max® is located at most developed engineering industrial estate in Vadodara,one of the fastest growing city and engineering hub of Gujarat State, The city is well known for its rich culture and royal heritage of King Sir Sayaji Rao Gaekwad 3rd. The engineering industries of this city stand best in the country with all hi-tech facilities and advanced resources. Companies like Reliance, Bombardier, FAG, L & T, Siemens, ABB, SUN Pharma, Alembic etc. have big set up in this city.


Implants & Instruments


Implants & Instruments


Implants & Instruments


Implants & Instruments