TT Electronics’ Asia facility receives FDA approval for Class IIa devices

TT Electronics, a provider of manufacturing solutions and engineered technologies, has announced that one of its Asia electronics manufacturing facilities has received approval from the Food and Drug Administration (FDA), through its premarket approval (PMA) supplement evaluation process, to manufacture Class IIa devices on behalf of global medical OEM customers.

The FDA registration of TT Electronics’ manufacturing site in Dongguan, China underscores the company’s commitment to upholding the highest standards of quality, safety, and regulatory compliance in the provision of manufacturing solutions for global healthcare markets.

Michael Leahan, chief operating officer at TT Electronics, said: “We are thrilled to announce the FDA registration of our Dongguan China manufacturing site. TT Electronics has been supporting medical and life science innovators for over a decade. This achievement is a testament to our relentless pursuit in delivering manufacturing excellence for our customers and contributing to the development of safe and reliable medical products.

“Having multiple FDA registered facilities enables TT to continue supporting our customers’ growth in international markets and reinforce our reputation as a trusted provider of electronic manufacturing solutions for products that help shape the future of healthcare.”

TT Electronics continues to broaden its global manufacturing offering including a new facility in Mexico, which will be operational in 2024 and will also work towards being ISO 13485 registered.