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醫療器材UDI 日期規範 DD內容不可使用00

2019-05-24

為避免造成條碼登記廠商於醫療器材之日期標示混淆,特此分為兩部份說明:(一)醫材包裝標籤日期標示規定(二)UDI之生產資訊(PI)日期格式標準,讓醫材廠商應用GS1標準於UDI標示時能有所依據。

一、醫療器材包裝標籤日期(人眼辨識)標示規定
1.台灣食藥署-醫療器材單一識別系統規範第六條規定包裝標籤日期標示,宜以西元年月日格式(YYYY-MM-DD) ,純數字呈現。前項日期格式之適用範圍,包括製造日及保存期限等。
2.美國FDA HHS規定醫療器材標籤日期格式依據: 801.18 Format of dates provided on a medical device label. (a) In general. Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month, using two digits; followed by the day, using two digits; each separated by hyphens. For example, January 2, 2014, must be presented as 2014–01–02.

二、UDI之生產資訊(PI)日期格式標準 
1.依據GS1 US 發佈UDI Implementation Guideline說明UDI資料編譯UDI日期格式標準說明:UDI若是採用GS1組織核發之編號與條碼標準,則UDI 條碼攜帶資訊內容關於日期(效期或製造日)格式是要求YYMMDD 6位數字,DD內容是不可以補零。
Important: Per the UDI Rule, the standardized date format of YYYY-MM-DD does not apply to how dates are encoded in a GS1 Barcode. The standardized date format only applies to the text (non-barcode) format of dates on labels/packages. Thus, the YYMMDD format used to encode the AI is permissible. See section 4.7 and Figure 4.7-1 for further explanation. The UDI Rule requires that the day be specified. Therefore, a “00” value in the DD segment is not permitted by the UDI Rule.
2.依據GS1 US 發佈在美國FDA UDI規則FAQ中也特別提及DD內容不允許是00。
The UDI Rule requires that the day be specified. Therefore, a “00” value in the DD segment is not permitted by the UDI Rule.
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