Renewing a medical device manufacturing license in South Korea is critical for ensuring the safety and efficacy of medical devices in the market. The renewal process can be complex and time-consuming. This guide provides tips to any company seeking to renew their medical device license, including criteria for renewal, how to fill in a medical device license application, common mistakes to avoid, and the consequences of non-renewal.

When it comes to gaining Regulatory approval for medical devices, manufacturers must navigate a complex and time-consuming pathway. However, there is a powerful method at their disposal – the pre-Request for Designation (pre-RFD) submission. The pre-RFD submission allows manufacturers to seek early feedback from the United States Food and Drug Administration (US FDA) prior to embarking on the official Regulatory process.

Radiation-emitting product labeling applies to all products that produce sonic, infrasonic, or ultrasonic radiation. This labeling regulation is applicable in conjunction with general labeling requirements. These regulations cover only the parts of specifications that is related to product labeling. It does not address any of the standards' technical requirements.

The US Food and Drug Administration (USFDA) has proposed the harmonization of the 21 Code of Federal Regulations (CFR) Part 820 Quality System Regulation (QSR) for medical devices in accordance with the International Organization for Standardization (ISO) 13485:2016.

Software as a Medical Device (SaMD) is a burgeoning field that offers innovative solutions to enhance patient care and reduce healthcare costs. The International Medical Device Regulators Forum (IMDRF) describes SaMD as a software tool intended for use in one or more medical purposes, and which meet these purposes without being part of a hardware medical device. SaMD includes both medical devices as well as in-vitro medical devices. The USFDA has implemented SaMD regulations to ensure that the devices meet the same safety and efficacy standards as traditional medical devices.

A combination product is a therapeutic or diagnostic product that combines drugs, medical devices, and/or biological products. It combines at least two (02) of these product categories and sometimes even combines all three (03) categories. One of the key growth drivers for this market is the increasing prevalence of chronic diseases such as diabetes, cancer, and cardiovascular diseases. Combination products offer an innovative way of treating these diseases, as they can be delivered directly to the affected area, resulting in more effective treatment.

A “predicate device” is a medical device that has been previously approved by the US Food and Drug Administration (US FDA) and is already on the market, which serves as a reference point for new medical devices seeking approval through the FDA’s 510(k) clearance pathway.

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.

What is an eCopy?

An eCopy is an electronic version of your medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or flash drive. An eCopy is accompanied by a paper copy of the signed cover letter. It is to be noted that an eCopy is not the same as a Food and Drug Administration (FDA) electronic submission [PKJ1]. Following are submissions that require an eCopy:

The 510(k)-clearance program, also known as Pre-Market Notification (PMN), is US FDA’s device review pathway to ensure safe and effective entry of medical devices into the US territory. US FDA requires manufacturers of the majority of Class II devices and a few Class I and III devices to obtain 510(k)-clearance.