First of all, second-class medical devices are largely divided into four categories: the same product, equivalent announcement product, clinical trial-free product (certification), and clinical trial-required product (license).
The screening process varies depending on the classification, so I explain it as below.
Therefore, manufacturers (importers) must follow the necessary processes below, depending on the product.
1. Acquisition of Manufacturing and Quality Control Standards (GMP) certification (Quality Manual, Procedures, Product Standards and Related Records)
2. Draft technical documentation and test inspection
- Electrical, radiation, electromagnetic waves, performance tests, etc
- Physical/chemical/biological tests, performance tests, etc
3. Technical document review and review
- Name, classification number, shape and structure, raw material, manufacturing method, purpose of use, usage method, precautions for use, packaging unit, storage method and duration, test specifications
4. Technical document review result notice
5. Obtaining a manufacturing (import) business license and certification and obtaining a license
6. The sale of Products
If you have any questions about medical device certification,
Please contact us with the below.
info@jnmglobal.net
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