What is ISO 13485 Certificate For Medical Device?

ISO 13485 Certification provides a comprehensive framework for medical device designers, manufacturers, suppliers, service providers, and distributors to assure quality, safety, and regulatory compliance. ISO 13485 is a distinctive QMS (Quality Management System) standard evolved from the globally recognized standard - ISO 9000.

Who can apply for ISO 13485 Certification For Medical Devices?

Designers, Manufacturers, Suppliers and Service providers and Distributors of Medical devices can apply for ISO-13485 certification.

How to apply for Medical Device ISO certification?

Importer shall apply for an import licence for test, evaluation or demonstration or training to the Central Licensing Authority in Form MD-16 through online portal along with the quantity of the medical devices, approved clinical investigation plan, documents and application fees. Test license in Form MD-17 will be issued from Central Licensing Authority after the review of the application.

Important Documents for Medical Device ISO certification?

Major documents for the application Brief description of the in vitro diagnostic kit including intended use, material of construction, design -Label and IFU