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Documents-Qualification Certification-Korea KFDA

Souhangwang https://www.sofreight.com/school/souhang_information_article?id=65602 2023-10-20 18:17:48

Documents-Qualification Certification-Korea KFDA

KFDA certification refers to the domestic product production and sales license issued by the Korean Food and Drug Administration. The Ministry of Health and Welfare (MHW) of South Korea, referred to as the Ministry of Health, is mainly responsible for the management of food, drugs, cosmetics and medical devices, and is the most important health care department.
In accordance with the Medical Device Act, the Ministry of Food and Drug Safety (MFDS) under the Ministry of Health and Welfare of South Korea is responsible for the supervision of medical devices.
South Korea’s Medical Equipment Consolidation Act divides medical devices into four categories (1, industrial, sub-class, and IV). This classification method is very similar to the European Union’s classification method for medical devices.
Class I: Medical devices that are not potentially hazardous:
Category: Medical devices with low potential hazards
Subcategory: Medical devices with moderate risk potential:
Class IV: High-risk medical device.

Foreign trade scenario: Exporting Korean medical devices

Step one: preparation phase. Determine product classification (l,l,Ill,IV).
Step 2: Class I products need to apply for a KGMP certificate and undergo on-site audits. Class II products generally require third-party auditors and obtain KGMP certificates. Step 3: Class II products need to send samples to the laboratory of MFDS in South Korea for testing. standard test
Step 4: MFDS submits technical documents (technical documents, test reports, KGMP certificates) and undergoes registration review and approval for 1 month
Step 5: Pay the application fee
Step Six: Registration document rectification, registration approval