COVID-19 pandemic is having an impact in many industries including medical devices and the electronic commerce. In fact, e-commerce has been experiencing a significant growth in the last months boosted by social distancing. Such changes present regulatory opportunities that we will further explore in this text. Specifically, we will take the case of Mexico.
General background
Offer
Before the current pandemic, some products considered as medical devices were already being sold through e-commerce platforms such as Amazon, Ali Express, Alibaba, Ebay, Wish, Mercado Libre and even Facebook Marketplace. The commerce of medical devices in these platforms exploded for devices used in treatment, prevention, and diagnosis of COVID-19.
Demand
Products like medical ventilators, oxygen generators, oximeters, face masks, face shields, thermometers, surgical gloves, sanitizers, and in vitro test kits were highly demanded devices with high prices and low stock in certain periods of time.
Opportunity
This unbalanced offer-demand was treated as a business opportunity by companies either involved or not in the medical device industry. By one side, manufacturers increased their production, and distributors offered those products on e-commerce platforms to get bigger sales. On the other hand, companies in need of medical devices found an “easy and cheap” way to get some of these products.
Regulatory background
Reliability
The E-commerce is an ubiquitous entity and therefore it is difficult to regulate it. In addition, sellers from all over the world exchange goods through these platforms and their regulatory knowledge could be limited. Even though e-commerce platforms (marketplaces) do their best effort to regulate the products, many of them do not necessarily comply with the regulatory requirements where the product will end up. For instance, products are often mislabeled as FDA, CE or ISO compliant as marketing strategies, which does not mean that they are necessarily able to sell those products in Mexico. In other words, not all these products has been approved by COFEPRIS.
Importations
Then, as a result of the covid-19 products high demand, there was an increased number on imports of medical devices in Mexico and customs authorities has had to enforce the application of import regulations. There were also exhaustive examinations performed in all shipment containing medical devices or similar products. Specifically, some COVID-19 related supplies that must follow certain guidelines.
This situation revealed a lack of compliance with requirements by companies and individuals previously importing regulated products without authorization. In some cases, the importer did not even know the tariff regulations for medical devices including the need of a Sanitary Registration and/or Import Permit.
Implications
A common example of negative implications takes place when healthcare professionals or patients buy medical devices from foreign manufacturers through e-commerce platforms located abroad. Once the purchase is completed, the provider will send the device by courier service such as DHL, FedEx, UPS without concerns about the regulatory requirements. The buyer will be later notified the device is detained at customs waiting for a COFEPRIS authorization to be released. Because the unawareness of medical device regulation in Mexico, the buyer will spend a big amount of money for storage fees and other expenses. In most cases the buyer will try to get an import permit not requiring a sanitary registration, but these requests are often rejected by COFEPRIS.
Finally, the medical devices found in e-commerce platforms may represent a sanitary risk because of an inadequate handling and storage in warehouses not meeting the conditions and staff required to keep the quality and traceability of the devices. It is worth mentioning that this does not necessarily mean that it occurs in all platforms or products. We understand the regulatory framework is a challenge for the E-commerce and most of them are doing its best effort to overcome it.
Conclusions
Based on this analysis, it is important to check with the seller that they have the authorization in the country you will receive the product. In other words, if you buy in Mexico, it does not mean that the FDA approval is enough. The COFEPRIS authorization is still a requirement. This will guarantee that your product complies with the local regulation and that a legal entity in Mexico is responsible with its compliance and appropriate warehousing.
In case you need to know if your product is a medical device in Mexico, feel free to contact us at contact@veraqueconsulting.com or check our Classification and Grouping guidelines.
