In compliance with FDA 21 CFR 807.40, we provide regulatory agent services (US Agent) for medical device companies.

Medical Device ISO 14971 Risk Management Training Services.

QSR 820 system counselling in the United States, BGMP system counselling in Brazil, JGMP system counselling in Japan, KGMP system counselling in Korea, UKCA QMS system counselling in the United Kingdom, FDA factory inspection counselling in the United States; and medical device system counselling in other countries.

MDSAP, Medical Device Single Audit Program MDSAP is a third party audit and assessment programme developed by the IMDRF organisation in 2014 to improve the safety and surveillance of medical devices for trade, resources and services. The aim is to achieve uniform recognition among different MDSAP member countries (TGA Australia, ANVISA Brazil, FDA USA, HC Canada, MHLW & PMDA Japan) through a single audit process.

Unique Device Identification (UDI) for medical devices is a series of numbers, letters or characters created by globally recognised device identification and coding standards, which includes Device Identification (DI) and Production Identification (PI), used to uniquely identify a medical device, and is regarded as a unique ‘identity card’ for medical device products in the supply chain. UDI is regarded as the only ‘identity card’ for medical device products in the supply chain.

For new customers, product registration and listing services are provided at a fee; for existing customers (assisted by our 510(k) agent registration), product registration and listing services are provided free of charge.

According to the requirements of the US FDA, manufacturers (including OEM processors) exporting finished and semi-finished medical devices to the US market should register their businesses in the US FDA system.