Quality Management For Medical Devices From South Korea

Where the standards of medical products a decade ago were extremely bad, it looks like there has been a lot of efforts to make the standard requirement close to the international requirements such as ISO, the Korean companies who are involved in manufacturing of medical related products now need to meet the standards of KGMP (Korean Good Manufacturing Practice) which are very close to international standards ISO.


Companies manufacturing class II, III, IV devices must have a certificate from KGMP before they can submit a new device application. There is no substitute to this rule and the certificate gives a number of rights which are such as new device application, change in parts of existing machine for updating it and other rights.

The companies have several ways through which they can apply for the certificate but the recommended way is to apply through a third party auditor. Once applied for the certificate, the medical device management team of Ministry of Food and Drug Safety will pay a visit for a thorough inspection for compliance and once the company facility meets the standards they can acquire the certificate from KGMP.

As one of the major players in electronics Korea is striving hard to get accepted globally in the medical device market and as far as standards are concerned they have done a good job in the past decade. The Korea Food and Drugs Association standards have two major bifurcations, one is horizontal standards for electrical safety, biological safety, electro-compatibility and safety testing requirements and second is vertical standards for respective product categories.


There are some pre-market requirements to be met before you can market the products and those are one, you need to have product license and two, you need to have quality system-regulation KGMP audit and regulation.

Technical document review, clinical review reports, efficacy review reports with patents are required before you can launch a new device with any new or added or new and added features. There are so many new devices launched and are tested that these regulations play a very important role in assuring safety for the people.

Some rules are also been made to assure post-launch safety and those relate directly to the clinical reviews every year or every two years depending upon other certificates and tests. There is also a provision made for the manufacturer to choose which month would he like to have the device reviewed but it always turns out to be a surprise review to keep the essence of review alive.

Health issues are to be given the first priority always and hence the government of Korea has made sure to keep things intact and they have made sure to have strict regulations for the imported medical devices as well. Importers need to hold a certificate of quality given by KGMP and need to hold other important reviews in place before they can market their products in Korea. Korea has significantly become aware of medical related products and has improved the standards.