Regenerative medicine Sale

The new regulations (after 25th Dec, 2014) can be summarized as follows.

《Enforced from 25th Dec, 2014》
License is required for manufacturing and selling regenerative medical products.
The license for manufacturing and selling regenerative medical products is valid for 6 years.
※ License is not required for the following cases:
  1. When a product produced/imported by manufacturing seller is stored or displayed in purpose of selling/endowing, or selling/endowing them to a manufacturing seller/manufacturer/seller.
  2. When a product produced/imported by manufacturing seller is stored or displayed in purpose of selling/endowing, or selling/endowing them to a doctor/dentist/veterinarian/hospital/clinic/a person who established veterinary facilities.
  3. When a product produced/imported by manufacturer is stored or displayed in purpose of selling/endowing, or selling/endowing them to a manufacturing seller/manufacturer/seller.
This article is written based on 1st paragraph under article 40 of Pharmaceutical and Medical Devices Law)
The regenerative medical product is defined in the revised pharmaceutical law, which includes new concepts of quality, validity, and safety of drug and medical devices.
The regenerative medical product can be defined as follows (in compliance with paragraph 9 of article 2)

  1. A product containing materials cultivated for human or animal cells in purpose of medical treatment or veterinary treatment, of which cases can be defined as follows

  2. A product which regenerates physical organ of human or animal including its function

  3. A product which cures or prevents a disease of human or animal

  4. A product, which cures a disease of human or animal, and also include a gene, which can result in transfection in a body

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