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TEBC-東騰生物科技有限公司-法規部-Regulatory Affairs Department-

東騰生物科技有限公司法規部目地是在幫助各製造廠或代理商合法販售醫療級產品於世界各地,在各項醫療法規和臨床試驗等均有專業團隊等協助。

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TEBC-東騰生物科技有限公司-法規部-Regulatory Affairs Department- | regulatoryaffairs.tebc.com.tw Reviews
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DESCRIPTION
東騰生物科技有限公司法規部目地是在幫助各製造廠或代理商合法販售醫療級產品於世界各地,在各項醫療法規和臨床試驗等均有專業團隊等協助。
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KEYWORDS
1 經營理念
2 專業、信任
3 各地,在各項醫療法規和臨床試驗等均有專業團隊等協助
4 一、各項醫療器材設計至產品上市之諮詢與輔導
5 二、醫療器材臨床試驗送件資料準備/申請/代辦
6 三、符合醫療器材優良製造規範申請
7 四、藥品/動物藥品/醫療器材/化妝品/食品等許可證查驗登記申請
8 五、臨床前試驗服務 實驗室及動物試驗、優良製造廠等諮詢
9 六、其他衛生法規諮詢
10 如何申請醫療器材許可證
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經營理念,專業、信任,各地,在各項醫療法規和臨床試驗等均有專業團隊等協助,一、各項醫療器材設計至產品上市之諮詢與輔導,二、醫療器材臨床試驗送件資料準備/申請/代辦,三、符合醫療器材優良製造規範申請,四、藥品/動物藥品/醫療器材/化妝品/食品等許可證查驗登記申請,五、臨床前試驗服務 實驗室及動物試驗、優良製造廠等諮詢,六、其他衛生法規諮詢,如何申請醫療器材許可證,東騰生物科技有限公司 法規部,regulatory affairs department
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TEBC-東騰生物科技有限公司-法規部-Regulatory Affairs Department- | regulatoryaffairs.tebc.com.tw Reviews

https://regulatoryaffairs.tebc.com.tw

東騰生物科技有限公司法規部目地是在幫助各製造廠或代理商合法販售醫療級產品於世界各地,在各項醫療法規和臨床試驗等均有專業團隊等協助。

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TEBC-東騰生物科技有限公司-法規部-Regulatory Affairs Department

http://regulatoryaffairs.tebc.com.tw/QA/example.html

廠商須先取得藥商登記,向所在地直轄市或縣(市)政府衛生局申請核准登記,國產(製造)業者需取得 製造業藥商許可執照 、進口(輸入)業者須取得 販賣業藥商許可執照。 Laser surgical instrument for use in general and plastic surgery and in dermatology). 須載明授權登記 (authorized to register). 1所有產品皆須檢附產品之圖樣 方塊圖,含結構說明 、各部份組成材料 與人體接觸者 ,圖樣上所示結構須能對照至其材質說明. 儀器類的安全性測試,包括電性安全 如IEC 60601-1 、電磁相容性 如IEC 60601-1-2 、輻射安全防護 如IEC 60601-1-3 、醫療器材軟體確效 如IEC 62304 等。 生醫材料的安全性測試,包括生物相容性 如ISO 10993 、滅菌確效 如EN 556 、熱原試驗 參照各國藥典 等。

2

TEBC-Regulatory Affairs Department-

http://regulatoryaffairs.tebc.com.tw/ra.html

Profession . Trust. TEBC Regulatory Affairs Department is focusing on importing every. Innovative product for all the manufacturers and importers. Also, TEBC’s. Professional teams can conduct clinical trials and PreMarketing Approval. TEBC offers a wide range of services to help sponsors whether in Taiwan or. Overseas from design phase to approval and other needs. Clinical trial design and management. Quality System and Certificationn. Preparation of medical device clinical trial submission documents.

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TEBC-東騰生物科技有限公司-法規部-Regulatory Affairs Department-問題討論-Q&A

http://regulatoryaffairs.tebc.com.tw/QA/QA.html

目前藥局、便利商店、大賣場、藥粧店多已領有藥商許可執照,民眾購買時,請注意產品之包裝或標籤應明確標示醫療器材許可證字號,如衛署醫器製 輸 字第000000號、衛署醫器製 輸 壹字第000000號等。 2應注意外盒包裝是否有完整標示,如品名、衛署許可證字號 衛署醫器輸字第* * 號或衛署醫器製字第* * 號 、製造廠名稱及地址、藥商名稱及地址、製造日期或批號、有效期間或保存期限等。 2應注意外盒包裝是否有完整標示,如品名、衛署許可證字號 衛署醫器輸字第* * 號或衛署醫器製字第* * 號 、製造廠名稱及地址、藥商名稱及地址、製造日期或批號、有效期間或保存期限等。 5應注意外盒包裝是否有完整標示,如品名、衛署許可證字號[衛署醫器輸字第* * 號或衛署醫器製字第* * 號]、製造廠名稱及地址、藥商名稱及地址、製造日期或批號、有效期間或保存期限等。 1]外盒包裝是否有完整標示,如品名、衛署許可證字號[衛署醫器輸字第* * 號、衛署醫器製字第* * 號或衛署醫器陸輸字第* * 號]、製造廠名稱及地址、藥商名稱及地址、製造日期或批號等。 電話 0800-45-8899 or 03-5743881. 東騰生物科技有限...

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