Medical device import business permit cases
1. Medical device import business license case
These days, there are many clients who want to import and sell medical devices.
In most cases, it is blocked by the quality manager.
We provide guidance on how to obtain an import business license.
2. Key Progress Stages of Medical Device Import Business
Import business license is largely Preparation – Application – Review – IssuanceIt goes through the process of.
Issuance of permits and payment of license fees: Once all requirements are met, an import business license will be issued.
Hiring a Quality Assurance Manager: You must appoint someone with a degree or experience in a related field (engineering, science, medicine, etc.). (This is the first hurdle to overcome.)
Secure the facility: Where medical devices can be stored storageAn office is required. The warehouse must be sanitary and may require temperature/humidity control. (Warehousing consignment contracts are also available.)
Application submission: Submit the application form and documents proving the qualifications of the quality control manager through the Ministry of Food and Drug Safety's 'Medical Device Electronic Civil Complaint Center'.
On-site audit and review: The local Food and Drug Safety Office will review documents and conduct warehouse inspections if necessary.
3. Management points after reporting
After reporting, you must register the UDI code.
Quality control standards must be followed, and supply history reports must be submitted annually.
Additionally, you must receive training from your Quality Assurance Manager, which is provided periodically.
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Because medical device import business permits must be processed at the same time as medical device product reporting,
If either of the two tasks is difficult, progress will be delayed.
Thank you for your hard work 🙂
