Class 1 medical device application

The class 1 application of medical devices is the most applicated class because it is a simple procedure compared to the certification and authorization procedures.
The products that have recently been reported a lot with the first grade are as follows, and we will inform you of the brief reporting process and necessary documents. 

등급	분류번호	품목명
1	A59060.01	a manual cervical extensor
	A01060.02	electric examination chair
	B07090.02	compression Bandage
	A67050.01	manually-operated bone surgical,
	B07050.01	non-contact type reusable surgical Drape
	C21010.01	Dental implant treatment instrument
	B07010.02	patient examination Glove

 

The class 1 application will be filed by the National Institute of Medical Device Safety Information, and the documents submitted are slightly different for each item.

The items listed in the declaration form are as follows.
1. Name (product name, item name, model name)
2. Classification number (class)
3. Shape and structure (principle of action, appearance, dimensions, characteristics)
4. Performance
5. Purpose of Use
6. How to use it
7. Precautions for Use
8. Manufacturer
9. Note: If it is applicable to export medical devices, disposable medical devices, used medical devices, one set medical devices, and combination medical devices, enter it.

 

The average processing period for a Class 1 application is 1-2 weeks.
In order to efficiently carry out the complementary rate of civil complaints, please refer to the ‘civil petition guide below for the preparation of the class 1 medical device application’.

1등급-체외진단의료기기-제조·수입-신고-신청관련-민원인-안내서.pdf

0.24MB

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If you have any questions about medical device certification,
Please contact us with the below. 

info@jnmglobal.net