Therapy Areas: Devices
Sanmina achieves both FDA registration and medical design registration in India
6 April 2018 -

Medical products company Sanmina Corporation (Nasdaq:SANM) stated on Thursday that its manufacturing facilities in Chennai, India has now passed the FDA registration.

The company operates a product design centre in Chennai, India under an ISO 13485 medical design registration, allowing it to design medical instruments for its customers, close to its manufacturing facility.

Following the successful registration, the Indian company is now able to manufacture finished medical instruments and devices in the country as well as becomes the first tier 1 EMS (Electronic Manufacturing Services) company to achieve FDA registration in India.

Concurrently, the FDA registration allows the company's Chennai site to produce finished products: imaging systems, blood glucose meters, patient monitors and many other complex medical instruments and devices.

The company manufactures complex products for the world's leading medical OEM companies in 20 medical manufacturing facilities worldwide as well as designs medical products in three centres with ISO 13485 design registrations. The quality system and audit protocols under the FDA registration ensures stringent manufacturing controls and documentation during production of finished medical products that guarantee safety, quality and regulatory control.

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