The importance of getting certified
Counterfeit products and fake certificates can be dangerous for both consumers and businesses. In such challenging times, ensuring the quality and authenticity of products, especially medical supplies, are more important than ever. As nations race against time to acquire sufficient supplies, it is not surprising that TIC Council has reported an increase in non-conforming imported Personal Protective Equipment (PPE), medical devices, and fake certifications.
Wednesday, 21 October 2020
Counterfeit products are more than just “fake goods”, they can be dangerous and, at its worst, deadly. The COVID-19 pandemic has seen a surge in demand for medical supplies and at the same time a rise in the number of false products in the market. The unintentional or intentional use of such counterfeit products can pose great risks to the health and safety of users due to lack of performance, missing safety or increased spread of harmful germs, bacteria and viruses.
Placing fraudulently marked or non-compliant equipment on marketplaces can also implicate importers and retailers with penal responsibilities as such acts mislead and endanger the health and safety of the public. In Singapore, the Health Sciences Authority reported that it had removed more than 1,700 listings of products making false COVID-19 claims from local websites alone. Out of these listings, 88% relate to medical devices, hand sanitisers and disinfectant sprays. Sellers who list products that make false claims in relation to COVID-19 may face a prison term of up to a year and a fine of up to $20,000, or both.
Along with an increase in fake goods and certificates, the TIC industry is also experiencing increasing demand for testing and certification services. According to researchandmarkets, the rise in demand for TIC services is due to increased regulations and number of referenced standards by governments and international standardisation institutions. This could also be attributed to the fact that consumers have a greater appreciation of quality and safety in the products that they consume. Manufacturers also understand the need to demonstrate quality and maintain their credibility through certification of their products.
As the value of certification increases, fake certificates and malpractices by errant certification organisations are also on the rise. There are reports of “agents” claiming to be able to assist manufacturers in attaining the EU’s CE certification, which could take weeks or years to complete under normal circumstances. Businesses that are eager to increase the worth of their products and to meet international demands may be lured by these quick fix certifications or may themselves be genuine victims of malpractice. Fake certifications jeopardise public health and unnecessarily increase risks to healthcare professionals and consumers. It is recommended that a business seeking certification services should conduct proper research on the certification company to check if they are a designated Notified Body, accredited according to established accreditation standards recognised by relevant government authorities, able to provide clear information of its scope and certification status of manufacturers and their products on a publicly accessible platform e.g. website.
Businesses and consumers should also pay close attention to the certificate issued and the certification marks. The certification mark, scope of certification, certificate reference number and validity period of the certification should be properly detailed on the certificate. Some test reports may also carry a watermark of the certification mark. Unclear or blurred certification marks, lack of details or inconsistent information on the conditions of the certification, erasings or black markings on the certificate holder’s details may suggest that a certificate could have been doctored.
Where counterfeit products are concerned, it is more than likely that they have not been tested nor certified and hence cannot be assured to perform as stated. Some established firms may have put in place authentication systems where customers can validate the authenticity of their products through tags or QR codes on the packaging. These authenticating systems can help to protect the brands and also the customers from fraudulent products. Evidently, the high incidence of fake goods and certificates is a global issue that must be tackled fast as case numbers make a steep climb.
In an article published in June 2020 on China Business Law Journal, it was reported that out of more than 140 suppliers of COVID-19 related medical supplies in China, 42% lacked the required qualifications or licenses, 37% showed no evidence they could meet with expected production capacity or had limited or no elated experience, and 27% had regulatory or legal issues.
In April, India Today published an exposé on underground PPE workshops in Delhi and Meerut that manufactured unsafe PPEs – which were meant for use in clinical setups and were required to be resistant to blood, body fluids and microbes. This prompted the Union Textile Ministry to tighten regulations on the manufacturing of PPEs and to release a new memorandum for stricter quality control.
Over in the UK, 400,000 medical gowns from Turkey meant to ease the shortage of supply in the National Health Service (NHS) were impounded due to poor quality issues in May. Prior to this, ministers had said that the shipment would be “significant” in easing the shortage of gowns in the NHS. The use of PPEs, such as medical gowns in the case above, is key for protecting medical professionals in the fight against COVID-19 – fraudulent products can place these front liners at unnecessary risk. With stricter and tighter regulations, proper assessments and surveillance can help significantly reduce such incidences thereby protecting businesses, healthcare professionals and individuals.
In the field of medical supplies, application of standards may differ across countries and certification may not be mandatory in some countries. In addition, accreditations for certifiers of medical equipment and supplies can be very specific. Certifications can also be mandatory or voluntary. Both mandatory as well as voluntary certifications are based on standards. In case of a mandatory certification, the certification is mandatory for accessing a defined market and required in regulations of that market. Voluntary certifications are offered for markets not requiring a mandatory certification for the certified product. However, certification transcends beyond medical supplies, it is important for all products.
For manufacturers, certification marks lend credibility to the brand as a proof to current and prospective customers that the product has gone through stringent audits and tests. This equips brands with a competitive edge to break into new markets and maximise the potential of existing markets, as a proper certification mark ensures that products meet with global standards.
Third-party certification marks, such as those offered by TÜV SÜD, are an added security for brands, serving as an objective source that affirms that a product was truly evaluated, tested, and deemed to comply with applicable standards and regulations given by law(s). Third-party assessment also assures distributors, providers as well as consumers that a product is compliant to set regulations and meets safety requirements and quality expectations.
To curb the spread of fraudulent and non-compliant equipment or devices, the TIC Council is recommending for any purchaser of PPE equipment and/or medical devices to verify the validity of any claims of compliance and certificate of conformity. This can be done by requesting a certificate, validating the certificates by contacting the Conformity Assessment Body identified on the certificate, and to duly contact the TIC Council if any fraudulent activity were detected.
The NANDO website by the European Commission also allows businesses to check if the certification organisation is a designated Notified Body. A Notified body is an organisation that has been appointed by an EU member state to assess whether manufacturers and their medical devices meet the requirements set out in the legislation. Where a Notified Body is involved, the certification of the product or system will typically be mandatory and not on a voluntary basis.
Businesses are also recommended to always authenticate claimed certifications, understand its certification basis (i.e. mandatory or voluntary) and verify its validity and scope. To facilitate this, leading Certification Bodies such as TÜV SÜD has made this information readily available on the public domain. Businesses can verify the authenticity and validity of certificates issued by TÜV SÜD through our online “certificate explorer” platform or through direct enquiry should the information be unavailable on the platform. TÜV SÜD is also working on improved and increased measures to ensure greater protection of certifications.
To combat counterfeiting and product piracy, TÜV SÜD’s Product Service registered their CE 0123 marking as an EU trademark. By affixing the CE marking on products and services, manufacturers can confirm that their products and services fulfil all product-specific EU directives and regulations on safety and functionality, and that they have carried out and documented a conformity assessment procedure to prove compliance. A CE marking followed by a four-digit identification number, which varies due to different registration numbers in accordance to different legal entities, indicates that a Notified Body was involved in the conformity assessment.
TÜV SÜD’s Product Service had also, in 2019, registered its five main certification marks in accordance to the new European trademark regulation. The TÜV SÜD Octagon marks that come in different variations and the TÜV SÜD GS-Mark, at the EUIPO new trademark protection scheme as “EU Certification Marks” provides for a more comprehensive protection. It is also important to note that TÜV SÜD’s customers are only allowed to use the certification marks, which clearly indicate the standard which the certification applies to; the use of the TÜV SÜD Logo is not permitted.
Under this improvement, TÜV SÜD will report all forgeries or misuses of its certificates to the EUIPO IP-Enforcement Portal, enabling trademark owners to notify EU law enforcement entities about infringements against trademark rights or laws. Being transparent is key in tackling such issues and such infringements will be published in TÜV SÜD’s blacklist. If an infringer is located within the EU or European Economic Community, TÜV SÜD will start direct legal interactivities including the issuance of a cease and desist, or a request of payment of contractual fines or damage compensation as agreed upon under the “TÜV SÜD Testing & Certification Regulation”.
Falsely representing a product or certificate is unlawful and can be deadly if the product does not fulfil the intended performance and safety regulations. These heightened risks unnecessarily stress the health systems especially during COVID-19 where safety is of paramount interest. Weeding out these fake products and certificates can be a tedious process and usually requires a robust system of checks and balances. It is hence important that there are laws governing actions, stipulating requirements and imposing penalties for misconduct or malpractices. Certification provides a form of checks by virtue of its process and can help ensure that a product meets required standards, thereby protecting the health and safety of consumers and health professionals.
Ensure ongoing compliance with standard during the pandemic
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