Carlos Pérez
Director General

Registry Plus Certification a Winning Formula

Wed, 09/07/2016 - 12:53

Third party authorized centers are invaluable to COFEPRIS when it comes to product evaluation for sanitary registration. With 20 years of experience as a certification and inspection body for electric and electronic devices, and with official branches in countries such as China and Colombia, NYCE decided to tap into the Mexican pharmaceutical and medical device sector as soon as the government authorized third parties. NYCE is one of the 19 third party centers but the only one offering the possibility to obtain product registrations along with certifications that comply with international standards. “This has helped us develop both technical and professional capabilities, which are indeed very difficult to replicate,” says Carlos Pérez, Director General of NYCE.

Global standards represent a major trend and all industries are moving toward homogeneity. Standardization makes it easy for companies to expand. NYCE is a certification and standardization body capable of implementing international canons for electronics, telecommunications, IT and more recently, healthcare devices. In Mexico, there are 11 standardization entities and NYCE is one of the larger ones. It also offers validation services in the form of conformity assessment, as regulatory requirements are not considered standards but specifications to comply. It decided to establish operations in China because 65 percent of electronics consumed in the world are manufactured there and they need to comply with local regulations and official norms to enter the Mexican market. Having a representation of its services near the manufacturers was a significant move for NYCE and it now holds a recognition agreement with a Chinese laboratory to ensure product compliance according to Mexican requirements. This helps manufacturers avoid logistics expenses associated with sending products for evaluation and makes their entry easier.

“Regarding medical devices the largest producers are European and American companies, therefore we contact them to offer a package including product registration with COFEPRIS and certification for electronic devices,” says Pérez. Most third parties in the healthcare industry do not certify electronics and this is one of NYCE’s main differentiators. Unlike other third party entities, NYCE is directly involved with several industries. NYCE’s multisectorial experience is a great competitive advantage.

“Today we have 8 percent of the healthcare Industry third party units’ market share and having evaluated 650 medical devices so far we are the third largest in the market according to COFEPRIS,” says Pérez. The market is dynamic and based on price so companies should focus on offering a better customer experience. According to Pérez, a recent market study showed that price is not the only element defining customer preference. Clients are seeking high quality-services, active support from their partners and experienced customer service. Equipment certification should not be viewed as a tool to simply gain access to a market but to provide customers and end consumers with safe and efficient equipment.

NYCE will continue expanding its capabilities to several areas outside of electronic and medical devices. In the next few months it will cover herbal medicines and COFEPRIS will release the bid for pesticides, plaguicides and fertilizers. “We are training our staff in these fields and we will approach chemical companies to offer third party evaluations for their products,” says Pérez. NYCE wants to become accredited in conducting good manufacturing practices audits in pharmaceutical plants since it believes that ensuring quality manufacturing will help get products registered quicker. At this point, audits in medical devices plants are attractive as most of the production is exported and would not impact product registrations in Mexico. Nevertheless, quality certifications should definitely be recognized in destination countries. “As COFEPRIS gains international recognition we expect Mexican registrations and norms to be valid around the world,” says Pérez. “Our activities and efforts will certainly impact more countries in the short to medium term.”