Medical Device Regulation and Certification in India
Medical Device industry in India has poor oversight and regulatory practices to certify, approve, and monitor what is being sold in the Indian market. India lacks controls when it comes to selling medical devices in the Indian market. Unlike FDA in the US, and CE in Europe, which require manufacturers to meet stringent standards, Indian market has been flooded with manufacturers who have fake certifications and are positioning themselves in front of buyers and purchasing departments that lack the knowledge and tools to differentiate fake from the authentic. Onus is on the purchasing manager of hospitals and other organizations that need these devices. Burden of proof also lies on companies with legitimate and authentic certification markings to present to the purchasing managers how they need to protect their respective organizations’ and protect the Indian consumer from companies with fake certifications.
CoVID-19 has understandably increased the demand for medical devices. Government increased funding to support both government run and private hospitals so they can meet the surge in sick patients and take care of what needs to be done. This demand has brought many new players to the market, but unfortunately this includes companies that have landed with fake certifications and are getting away with it.
Government e-Marketplace (GeM)
Indian Government has setup a portal called GeM (Government e-Marketplace) that requires government institutions, including hospitals, to purchase products via this portal. It is a great concept on paper. The issue is that currently there are companies with fake certifications and sub-standard products that have found their way onto the GeM portal. GeM desperately needs controls, know-how, and tools to filter out companies with fake CE certification.
CE Marking (Authentic vs Fake)
All CE certifications go through a body whose number is listed next to the CE symbol. For example, CE0123 depicts TUV SUD, a well-known and recognized body approved by the European Conformity organization.
Following link shows how companies are faking CE certification.
There is CE (European Conformance) and there is CE (China Export). Both symbols look alike with a subtle difference that only someone with knowledge can differentiate.
Following link can help to check the authenticity of a CE certification:
This is a profoundly serious issue and we encourage purchasing departments and GeM to do the necessary due diligence and weed out companies with fake certification.