According to 2022 medical device industry production and import/export statistics, It is an infectious disease diagnostic test reagent that ranked 1st in domestic production and export and accounted for 48.4% of exports.
Diagnostic reagents are mainly used in in vitro diagnostic devices.
In other words, the field of in vitro diagnostic devices, which has grown rapidly due to COVID-19, is expected to quickly examine various diseases and continue to grow.
In order to enter the growing in vitro diagnostic medical device market, the licensing process is essential.
What is an in vitro diagnostic medical device(IVD)? It refers to reagents, contrast and correction substances, instruments, machinery, devices, and software used alone or in combination to test samples derived from humans or animals in vitro.
In vitro diagnostic medical devices are classified into grades 1 to 4.
Please refer to the document below for detailed item grade.
Overall, the review data and attachments of technical documents are as follows.
1) Items to be filled out in the application form
- Name (product name, item name, model name)
- Classification number (class)
- Shape and structure
- Raw materials
- Manufacturing method
- Purpose of Use
- How to use
- Precautions for Use
- Packing unit
- Storage method and period of use
- Test standard
2) Data on technical documents
- Data on the origin/development history, detection or measurement principle/method
- Data on domestic and foreign usage status
- Data on raw materials and manufacturing methods
- Data on purpose of use
- Data on storage method and use period or expiration date
- Data to confirm product performance
- Data on Handler Safety
- Data compared with products that have already been licensed/certified
However, please note that the documents required for each grade and item of the in vitro diagnostic medical device are different.
If you have any questions about medical device certification,
Please contact us with the below.
info@jnmglobal.net
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