Nitrile Gloves for Medical Care, First Class Medical Device Import Permit and Report Guide for Korea

 

Seungmu Administrative law office, a specialized administrative law office.

 

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Before entering, the Ministry of Food and Drug Safety has the status of an administrative agency. In addition, licensing tasks such as importing and manufacturing medical devices are legal affairs under the Medical Device Act, and only lawyers and administrators under the Lawyers Act and administrative law cannot act on behalf of them.

 

​Our administrative office specializes in administrative law and licensing, and in addition to first-class medical device licensing, we are responsible for second-class GMP suitability screening and acting as a legal representative.

 

​We have completed the import license and import declaration of nitrile gloves, a powder-free product corresponding to first-class medical devices. Powder-treated products cannot be used for food or medical purposes, so please do not make a mistake.

 

​According to the medical device item notice, medical gloves are largely classified into grades 1 and 2 depending on whether they are sterilized in the manufacturing process.

 

​The first-class product is medical gloves, that is, gloves used to prevent infection or cross-contamination during treatment. On the other hand, grade 2 sterilized gloves are surgical gloves and are used between surgeries.

 

​Grade 1 medical gloves have almost the same ingredients as those imported for food, so there is no big problem registering them for medical use.

 

​As explained earlier, powder-treated products cannot be imported for food or medical purposes from 2019, so factories in China and other countries are producing powder-free products and exporting them for food and medical purposes according to the importer's purpose.

 

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Most of them report imports for food, obtain permission for medical devices through hospital bidding, and go through separate import procedures.

 

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In order to import for medical use, not for food, you need to obtain a grade 1 to 2 license. However, in the case of the second grade, consulting and testing costs are very expensive because there is a GMP screening and a test test test such as sterilization validation is required.

 

On the other hand, unlike the second grade, the processing period and cost are relatively simple compared to the second grade because only technical documents containing information such as raw materials are submitted and reviewed.

 

​Today, we will only look at documents for import business licenses and declaration of imported items with first-class medical devices.

 

​Documents required for import business license (the same applies to manufacturing business license)

 

Quality manager-related certificates (four-year science and engineering degree certificate or quality control department experience certificate registered as a medical company of the Ministry of Food and Drug Safety, which requires 2 to 4 years of experience depending on academic background)

 

In the case of an individual business operator, a representative health certificate in the business registration (no corporate business operator is required)

 

Business license (individual/corporate common)

 

A copy of the corporate registration (certification of all matters registered by the corporation) and the articles of incorporation

 

​Documents necessary for reporting imported items (the same for reporting manufacturing)

 

Product model name (model name for domestic sales, not the manufacturer's model name, model name should not be used for specific effects or exaggerated names depending on the medical device labeling

 

Actual picture of the product (the picture should show the shape of the product specifically)

 

Product drawings and sizes (such as CAD files with product design drawings and sizes)

 

MSDS (material safety and health data) containing information such as raw material of the product

 

Other documents deemed necessary for reporting by product

 

​As shown above, there is a difference between the import business license and the required documents for each import item declaration. The local Food and Drug Administration will first process the permission for the import business, and then the Medical Device Safety Information Service will report the imported items.

 

Therefore, if the work of the local Food and Drug Administration, which is in charge of the import business license, is heavy, the work of the Medical Device Safety Information Service may be postponed. In the case of the Seoul Metropolitan Government, the Gyeonggi Incheon (Gyeongin) Regional Office, and the Busan Regional Office have a lot of work, so you have to think about import licenses and item reports for up to 40 days, and an average of 30 days.

 

​Once the import business license and item license are processed, customs clearance will be possible, and you can sell the product after reporting the mail order business and medical supplies business.

 

Our administrative agency Seungmu is an administrative law office specializing in licensing and administrative trials such as medical devices, and we will repay you with the best results with reasonable fees.

 

 

feel free to contact us

​Thank you.