The FAMIDOC Journey

FAMIDOC was established and obtained ISO13485 and ISO9001 certifications

Obtained Chinese medical device registration certificates for five product categories including infrared thermometers, digital thermometers, wrist & arm blood pressure monitors and medical ultrasonic nebulizers. And secured the CMC (Certificate for Measuring Instruments) for infrared thermometers and wrist/arm blood pressure monitors.

Established YY/T 0287 domestic quality management system, and became the 1st domestic-funded enterprise in China to obtain FDA 510(k) clearance for infrared thermometers.

Co-drafted the professional standards for electronic thermometers with the Guangdong Medical Device Quality Supervision and Testing Institute.

Obtained FDA 510(k) clearance for digital thermometers.

Famidoc introduced and established the QSR820 and ISO 13485 under CMDCAS systems, successfully integrating and implementing four major quality management.

Obtained Medical Device Manufacturing License, covering and Class II Physiotherapy & Rehabilitation Devices.
Obtained CE-MDD Certificate by SGS for infrared therapy devices.

Joined Japanese MHLW Ministerial Ordinance No.169 quality system and obtained the Foreign Medical Device Manufacturer Certification from the Japanese government.

Obtained FDA 510(k) clearance for TENS and EMS stimulators.

Obtained mainland China’s first MDSAP (Medical Device Single Audit Program) Certificate issued by SGS. The resulting audit report serves as essential input for pre- and post-market reviews and provides key support for regulatory technical reviews across major global regulatory authorities, including the US FDA, Health Canada, Australia's TGA, and Japan's MHLW/PMDA.

Honored as the "Best Quality Supplier of the Year" by Braun for its Home & Healthcare product series.

Obtained CE MDR certificate

Famidoc relocated to Zhongtang Tian'an Cyber Park, established a commercial investment company in Singapore, and invested in building a new factory in Vietnam. Famidoc welcomes professional partners to work with us to create a prosperous new era for

Established Famidoc Vietnam Co., Ltd.

Leveraging Vietnam's low-cost manufacturing and ASEAN medical consumables market, serving as the parent company's core production hub in the region.