The medical device industry in India has poor supervision and regulatory approaches to provide CE certifications and monitor, what is being sold in the Indian market.
India lacks control 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.
The Indian market has been flooded with manufacturers who have fake CE mark certifications and positioning themselves in front of buyers and purchasing departments that lack the knowledge and tools to differentiate fake and authentic certificates.
The 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 from those companies who have fake CE certifications.
CoVID-19 has understandably increased the demand for medical devices like patient monitors, ECG, EMG machines, pulse oximeters, etc. And the government has 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 CE certifications and are getting away with it.
Government e-Marketplace (GeM)
Indian Government has set up a portal called GeM (Government e-Marketplace) that requires government institutions, including hospitals to purchase medical products via this portal. It is a great concept initiated by the government.
The issue is that currently there are more companies with fake certifications and sub-standard products and they have found their way onto the GeM portal. GeM desperately needs control, know-how, and tools to filter out companies with fake CE certification.
CE Marking & Certification (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.
CE Check has explained in one of their articles, how to differentiate a real CE mark certification from fake CE certification.
There is CE (European Conformance) and there is CE (China Export), Both symbols look alike with a subtle difference which only someone with knowledge can differentiate. The following data 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 certifications.