Yoloxóchitl Macías
Health Area Manager
ANCE
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Third-Party Authorizations Based on Fair Play

By Jan Hogewoning | Wed, 04/29/2020 - 18:18

Q: What are the growth opportunities for ANCE in the health sector?

A: One area of opportunity in the medical device sector is electromagnetic compatibility, as an example of this could be the new standard introduced by the Federal Institute of Telecommunications (IFT) related to the specific absorption rate (SAR) which measures the rate at which energy is absorbed by the human body when it is exposed to radiofrequency electromagnetic fields. On regards to this, ANCE is focused on being the first Mexican laboratory with the infrastructure required to perform it.

Our goal is to expand into several sectors.

Devices are needed everywhere and they must meet certain norms and regulations. In the health sector, COFEPRIS sees us as experts in helping clients to comply with regulations regarding devices and medications.

Q: What is your perspective on the healthcare sector?

A: COFEPRIS invited us to a meeting of authorized third parties. One of the things they stressed was that authorized third-party evaluations should take no longer than 15 days. This seemed a bit odd, as COFEPRIS still has the freedom to delay processes by months. One of the challenges as a third party is that COFEPRIS expects us to know everything and be able to explain everything to the client. Of course, much of our knowledge is based on COFEPRIS’ decisions. The commission is very strict when it comes to accepting new reviews of products. For clients, it is easier to work with a third party with fewer up-front demands.

Q: How has the market reacted to Novelo Baeza’s comment on adjusting the number of authorized third parties depending on market demands and priorities?

A: We did not have knowledge of this comment. We have personally experienced how effective it is to have contact with people inside the government. We would meet potential clients and the first thing they would ask was whether we had direct contact with COFREPIS, otherwise they would decline our services. At ANCE, we do not work like that; we want to play by the rules and offer a strong service that is solely based on our expertise. Fortunately, it seems that this kind of behavior is diminishing and many companies are glad to hear you do not have contacts inside COFEPRIS. They do not want to be in a situation where there could be an accusation of corruption. For us, playing by the rules is part of ensuring that the medical products that are approved do not end up harming people.

Q: In what areas do you see the most growth opportunity for your services?

A: Medical devices are very interesting because there is much more innovation in comparison to medications. The number of medical devices registered annually in Mexico is around four times larger than medications. We have traveled to different cities, including Tijuana, Guadalajara and the Monterrey area to strengthen our activities. In Tijuana, we have a strong relationship with the local cluster of medical devices. Our services are often tailor-made, meaning we discern what the client needs and adapt our offering to that. Of course, we are not just limited to healthcare. We also are studying the electromagnetic behavior of equipment used in different sectors. A lot of equipment does not necessarily need to comply with a certain certification but may still undergo some form of evaluation at the request of the client. We also run programs for the certification of management systems and certifications on sustainability and ethical practices.

Q: What are ANCE’s main goals for the near term?

A: We will continue to position ourselves as a company that provides an integral, and always ethical, service. Our services in the health sector can extend to all kinds of pharmacovigilance and techno-vigilance. We would like to play a role in educating the public about the risks of auto-medicating or using sterile products more than once. We want to make a broader contribution to society apart from providing our services.

 

 

The Standardization and Certification Association (ANCE) provides certifications, inspections, standardization, calibration and other services in a range of industries. In the health sector, it works as an authorized third party to provide inspection services for medicines and medical devices

Jan Hogewoning Jan Hogewoning Journalist and Industry Analyst