Experts Caution About Growing Trend Of Unknown Certification Agencies Of Medical Devices

Mumbai, 7 Oct 2020: 

Experts have cautioned about the growing trend of unknown certification agencies of medical devices claiming accreditation from global accreditation bodies (ABs) having addresses in EU, UK or USA, citing a white paper produced by a working group of the Testing, Inspection and Certification (TIC) Council on Anti-Counterfeiting.

The Anti-Counterfeiting Committee is a TIC Council Committee committed to stopping the worldwide proliferation of products bearing counterfeit certification marks that may endanger public health and safety.

Consumers, retailers, regulators and industries worldwide rely on TIC Council member certification marks to let them know that a product or management system has been certified to the applicable standards. Counterfeit certification marks deceive buyers into purchasing untested products that may cause serious injury, illness and death.

“The only recognized system of authenticating certificates exists under the International Accreditation Forum (IAF) of which National Accreditation Board for Certification Bodies (NABCB) is member from India and it operates as a mutual recognition arrangement for international acceptance of accredited certificates. IAF is now also creating a database of accredited certificates issued by its members globally and one could now verify certificates on its portal,” explained Anil Jauhri, former CEO NABCB.

The white paper talked about cases detected about counterfeit glucose patches with falsified certification marks in Honk Kong. The patches, vital to helping diabetics monitor blood sugar levels, were found to be ineffective and would have seriously compromised the health of those who rely on them. It also revealed cases about sub-standard face masks and fake hand sanitizers.

“These cases demonstrate how consumers’ health, well-being, lives and property are put at risk and why it is paramount to increase awareness of the problem and continue to search for products with falsified certification or testing reports. Identifying these products and their producers helps keep people safe and discourages future rogue operators from participating in such activities,” the white paper stated.

Prakash Tikare, country head for DNV GL Business Assurance India Pvt Ltd, shared the experience that the company receives many queries from buyers and medical boards of various countries asking for authentication of the CE certificates. DNV GL uses blockchain technology to store the certificates, for the last 2 to 3 years through which all the certificates are tagged and traceable, and can be scanned with a QR code scanner. Anyone can check and verify a company’s claims and gain confidence on the authenticity of the certificates issued by DNV GL. It is important for the customer to verify and confirm what they are buying is as per their requirement and expectations.

DNV GL is one of the world’s leading certification bodies, helping businesses assure the performance of their organizations, products, people, facilities and supply chains.

“Further unfortunately others—including manufacturers, importers, and other distributors—choose an alternative path and become rogue operators, intentionally bypassing the proper verification channels, counterfeit testing documentation, a certificate of conformity and/or include a fraudulent certification mark on the product label or packaging. Often this is done to save money and time in getting their products to market. These rogue operators take advantage of the system’s complexity or hope their products simply make it through customs un-noticed and therefore without penalty,” the white paper stated.

To place a product with a counterfeit certification mark or with counterfeited test documentation is often considered a crime in countries if the mandatory legal requirements are not met. Additionally, unauthorized use of the testing documentation and/or certification mark of a certification body is an infringement of the trademark rights of the certification body.

TIC companies provide regulatory authorities, manufacturers, distributors and consumers’ confidence that a product, process, system, or person meet a set of specified requirements. Pharmabiz