Taiwan: New GDP regulation for medical device
The Ministry of Health and Welfare in Taiwan has released the advanced draft "Guidelines for Good Transportation and Marketing of Medical Equipment" under Item 3 of Article 24 of the Medical Device Management Law. This draft will become effective in 2021. In order to obtain distribution license, distributors and manufacturers may require to apply for inspection by Taiwan's GDP. This draft will be enforced 2 years after implementation. The draft sets standards for documentation, organization, transportation, equipment, outsourced activities, complaints, returns and recalls.
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