[Press Release] Korea MFDS and Singapore HSA sign the Mutual Recognition Agreement on GMP for Medicinal Products 2024-02-27 [Press Release] Korea MFDS and U.S. FDA Lead Global Discussion on Advancing 2024-02-21; more News and Notice more information

Regulation on Good Manufacturing Practices (GMP) for Medicinal Products (No.2021-87, Nov 4,2021).pdf

2019年8月18日 · Korean GMP Regulations / 韩国GMP法规-----KGMP法规及相关文件的英文翻译。 在参考美国和欧洲GMP标准的条款时，我们选择了考虑到KGMP标准特征的最佳术语，并将其翻译为尽可能保持韩国人对KGMP标准的表达。-----

2024年3月21日 · As discussed in our first regulatory update, compliance with K-GMP (Korea Good Manufacturing Practice) is required for Class 2, 3 and 4 medical devices. Therefore, the K-GMP certificate is an integral step to entering the market in South Korea. There are four types of K-GMP audits: initial, additional, change and renewal. We describe them here:

Premarket GMP audit is mandatory for all class II, III and IV devices and class I (sterile and measuring devices). Currently, a KFDA guideline was published on “GMP audit for foreign manufacturers of imported products” and implemented with the time frame:

One major step for companies registering medium- and high-risk medical devices in South Korea is compliance with the Korea Good Manufacturing Practice (KGMP) quality system regulations. Similar to ISO 13485 quality system standards, KGMP is required by the Korean Ministry of Food and Drug Safety (MFDS) for all Class II, III, and IV medical devices.

2023年8月8日 · If your medical device or in vitro diagnostics company is looking to enter the South Korea market, you will need to comply with the Korea Good Manufacturing Practice (KGMP) standards and requirements.

Learn how TÜV SÜD can support the roll out of medical devices and IVDs in Korea with its Good Manufacturing Practice (GMP) Audit designation. With a population of over 50 million people, South Korea is one of the world's leading economic powers.

2023年3月14日 · When registering medical devices and pharmaceuticals in Korea, manufacturers must follow Korean Good Manufacturing Practice (KGMP) standards, which are similar to international standards for quality management systems (ISO 13485).

under GMP. Premarket GMP audit is mandatory for all Class II, III and IV devices and Class I (sterile and measuring devices). Certification of compliance to “Standards for manufacturing and quality management of medical devices“ (KGMP, similar to ISO 13485) Both, document review and site inspection conducted