At present, the epidemic situation in South Korea is very severe, and the demand for masks in the South Korean market has surged. Many exporters consult about what certification is required for exporting masks to South Korea? The sale of masks in South Korea requires KFDA certification. KFDA certification is regulated by the South Korean Ministry of Health. KFDA certification is mainly responsible for the management of food, drugs, cosmetics, and medical devices

The process of applying for KFDA certification for masks

1. Preparation stage.

. Determine product classification (I, II, III, IV) and select Han Li 2. Class II products require application for a KGMP certificate and on-site audit. Class II products are generally authorized third-party auditors and obtain a KGMP certificate 3. Class II products require samples to be sent to a laboratory authorized by MFDS in Korea for testing according to Korean standards 4. The Korean representative shall submit technical documents (technical documents, testing reports, KGMP certificates) to MFDS for registration and approval for one month 5. Pay the application fee in N/A 6. Rectification of registration documents and approval of registration 7. Designated Korean agents and distributors, with product sales N/A

The Korean Medical Device Law categorizes medical devices into four categories (I, II, III, IV), which is very similar to the EU's classification method for medical devices Class I: Medical devices with almost no potential danger Class II: Medical devices with low potential danger Class III: Medical devices with moderate potential danger Class IV: High risk medical devices Medical devices are classified based on: degree of danger, contact area and time with the human body, safety and effectiveness of the product Medical masks belong to Class II medical devices in South Korea, namely KFDA II

Korean registration related content:

(1) Apply for a KGMP certificate and undergo on-site audit (2) For Class II products, it is generally entrusted to an authorized third-party auditor to complete the audit (but in the case of the author's previous service, they are also officials of the Korean security department). If it is Class III

Function of testing report:

1. Project bidding: Issue authoritative third-party CMA/CNAS qualification report

2. Online e-commerce platform entry: Quality inspection report recognized by major e-commerce platforms

3. Used as a sales report: issuing legally effective testing reports to make consumers more confident

4. Papers and research: Provide professional personalized testing needs

5. Judicial services: providing scientific, fair, and accurate testing data

6. Industrial problem diagnosis: Verify the troubleshooting and correction of industrial production problems

100% inspection and testing process:

1. Telephone communication and confirmation of requirements

2. Recommend solutions and confirm quotations

3. Mail samples and arrange testing

4. Progress tracking and result feedback

5. Provide reports and after-sales service

6. If urgent or priority processing is required

Testing and testing characteristics:

1. The testing industry is fully covered, meeting different testing needs

2. Fully cover the laboratory and allocate localized testing nearby

3. Engineers provide one-on-one services to make testing more accurate

4. Free initial testing, with no testing fees charged

5. Self service order delivery for free on-site sampling

6. Short cycle, low cost, and attentive service

7. Possess authoritative qualifications such as CMA, CNAS, CAL, etc

8. The testing report is authoritative and effective, and is generally used in China