Qualtech is proud to celebrate our second webinar in the 2020 series: "Good Distribution Practice (GDP) in Taiwan" on June 17th , 2020. There are over 300 attendees from Japan, the United States, and Taiwan. We have selected three FAQs that may concern you.
If you are interested in our webinar, feel free to contact us!
Good Distribution Practice in Taiwan:
Taiwan’s FDA has issued a Good Distribution Practice Guideline for Medical Devices. With the new guidelines getting into force in the near future, relevant distributors will be required to obtain a GDP certificate before they can legally distribute medical equipment. In 2019, Qualtech has worked with TFDA in participating in a test run audit for Taiwan’s GDP, for which Qualtech has received high praise from the TFDA for its performance.
- If we have a branch office in Taiwan, what kind of audit do we have to participate in?
QT: TFDA(or related third party) will audit your Taiwan branch when the GDP implement. The office staff should participate in.
- What kind of documents are needed?
QT: Your Taiwan branch should prepare GDP-related SOP and records to manage the product distribution in Taiwan. These two documentation are the major parts as well.
- Are audited branch offices as well, or only HQ which holds the ISO certificate?
QT: TFDA only audit Taiwan branch office.