Q-submission FDA program refers to the system that tracks the collection of interactions with the FDA. It helps manufacturers of Medical Devices and in vitro diagnostics (IVDs) to obtain feedback from the FDA regarding Regulatory processes and requirements for the product during its development.
Medical devices in South Korea are regulated by the Ministry of Food and Drugs Safety (MFDS), formally known as the Korean Food and Drug Administration (KFDA). MFDS requires all foreign manufacturers wishing to market their devices in South Korea to appoint a Korean License Holder (KLH) to register their devices with the MFDS. The current article answers the major questions posed by the device and IVD manufacturers to appoint a KLH.
The Medical Device Single Audit Program (MDSAP) allows a recognized Auditing Organization (AO) to conduct a single audit of a medical device manufacturer’s Quality Management System (QMS). It furnishes relevant Regulatory requirements for five countries, i.e., Brazil (ANVISA), USA (FDA), Japan (PMDA), Canada (Health Canada), and Australia (TGA). Aside from the participating Regulatory authorities, several other international partners (the official observers and affiliate members) are involved in the MDSAP.
The US is the largest medical device market, worth USD 180 billion (2021) and is expected to reach USD 670 billion at a CAGR of 5.2% from 2022 to 2027. The global medical device manufacturers find it promising to get their devices approved by US FDA and subsequently export them to the US.
