法規名稱：醫療器材嚴重不良事件通報辦法

發布日期：民國 110 年 04 月 28 日

第 1 條
本辦法依醫療器材管理法第四十八條第二項規定訂定之。

第 2 條
本辦法所稱醫療器材嚴重不良事件，指因使用醫療器材致生下列各款情形之一或有致生
之虞者：
一、死亡。
二、危及生命。
三、永久性殘疾。
四、胎嬰兒先天性畸形。
五、需住院或延長住院。
六、其他可能導致永久性傷害之併發症。

第 3 條
1 醫療器材商為醫療器材許可證所有人或登錄者及醫事機構，發現國內醫療器材嚴重不良
事件時，應至中央主管機關指定之網路系統，將事件資料通報至中央主管機關，或其委
託之機構、法人或團體。
2 前項以外醫療器材商發現國內醫療器材嚴重不良事件時，得通知醫療器材許可證所有人
或登錄者。
3 第一項不良事件之通報，必要時，得先以口頭方式為之，並應依第五條或第六條所定期
限，補正前項網路通報。
4 未能依第一項及前項規定辦理網路通報者，應填具通報表（如附表），以紙本、傳真、
書信或電子郵件之方式完成通報。
5 第一項及前二項通報，其內容未完備者，中央主管機關或其委託機構、法人或團體，得
指定期限通知其補正。

第 4 條
1 醫療器材許可證所有人或登錄者及醫事機構為前條之通報，其內容應至少包括下列事項
：
一、通報廠商或機構之名稱、地址、聯絡方式及通報人姓名。
二、嚴重不良事件發生日期及發現日期。
三、醫療器材中文品名及許可證字號或登錄字號。
四、醫療器材之型號或規格及批號。
五、醫療器材直接供應來源及流向；通報者為不良事件發生之最終使用機構，無須通報
產品流向。
六、發生嚴重不良事件之醫療器材現況。
七、不良事件之類別及結果。
八、不良事件發生之描述。
2 前項第八款描述，應包括下列事項：
一、發生不良反應之部位、症狀及嚴重程度。
二、產品問題。
三、可能導致嚴重傷害之原因及過程。
四、病人後續處置。
 第 5 條
1 醫事機構應依下列期限為第三條之通報，並副知醫療器材許可證所有人或登錄者：
一、第二條第一款及第二款：自發現之日起七日內。
二、第二條第三款至第六款：自發現之日起十五日內。
2 醫事機構辦理前項通報，得要求醫療器材商提供通報表相關資料；醫療器材商應予配合
。

第 6 條
醫療器材許可證所有人或登錄者為第三條之通報，應於發現第二條事件之日起十五日內
完成。

第 7 條
1 醫療器材許可證所有人或登錄者完成前條通報後，應主動調查，評估矯正、預防措施採
行之必要性及矯正、預防措施之執行內容。
2 前項調查及評估結果，醫療器材許可證所有人或登錄者，應通報中央主管機關或第三條
第一項受委託機構、法人或團體；其通報方式，準用第三條規定；有採矯正、預防措施
必要者，並應將該措施，通知使用該醫療器材之醫事機構。

第 8 條
醫療器材許可證所有人或登錄者及醫事機構，應保存醫療器材嚴重不良事件通報內容
，及前條調查、評估與矯正、預防措施之文件、資料，其保存期間至少五年；五年內
，其許可證有移轉者，受讓人應於該期間內續行保存。

第 9 條
中央主管機關或其委託機構、法人或團體，得要求醫療器材商及醫事機構，提供醫療器
材嚴重不良事件之病人或醫療器材相關文件、資料；被要求者不得規避、妨礙或拒絕。

第 10 條
醫療器材商及醫事機構，依本辦法蒐集、處理或利用個人資料，應依個人資料保護法及
其相關法規規定辦理。

第 11 條
本辦法自中華民國一百十年五月一日施行。
2022/6/16 上午10:24 Regulations for Reporting Serious Adverse Events of Medical Devices - Article Content - Laws & Regulations Database o…

Print Time：2022/06/16 10:22

Article Content

Title： Regulations for Reporting Serious Adverse Events of Medical

Devices
CH
Announced Date： 2021-04-28
Category： Ministry of Health and Welfare（衛生福利部）
Attachment： Food and Drug Administration, Ministry of Health and Welfare
Medical Device Serious Adverse Event Report Form.pdf

Article 1 These Regulations are established in accordance with Paragraph 2

of Article 48 of the Medical Devices Act.

Article 2 The term "serious adverse events of medical devices" as stated

in these Regulations shall refer to the use of a medical device
resulting in occurrence or having potential to result in
occurrence of one of the conditions listed in the following
subparagraphs:

1 Death.

2 Life-threatening condition.

3 Permanent disability.

4 Congenital anomaly of fetus or infant .

5 Requiring hospitalization or prolonged hospitalization.

6 Other complications that may result in permanent injuries.

Article 3 Medical device firms, which are medical device license holders
or have completed the listing, and medical institutions shall
file a report on the internet system designated by the central
competent authority upon the finding of a domestic serious
adverse event of medical device and notify the central competent
authority or its commissioned agency, legal entity, or
organization .

In addition to the finding of a domestic serious adverse event

of medical device referred to in the preceding paragraph,
medical device firms may notify medical device license holders
or firms that have completed the listing.

When necessary, the reporting of adverse event set forth in

Paragraph 1 may be made verbally first and the supplementary
documents shall be submitted online later as referred to in the
preceding paragraph before the deadline specified in Article 5
or Article 6.

Those who fail to complete the online reporting in accordance

with Paragraph 1 and the preceding paragraph shall fill out a
reporting form (see Appendix) and complete the reporting via
paper, fax, letter, or email methods.

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If contents of the report of Paragraph 1 and the preceding two

paragraphs are not complete, the central competent authority or
its commissioned agency, legal entity, or organization may issue
a notification for information to be supplemented within a
specified period of time.
Food and Drug Administration, Ministry of Health and Welfare
Medical Device Serious Adverse Event Report Form.pdf

Article 4 Contents of the report filed by medical device license holders

or firms that have completed the listing and medical
institutions in accordance with the preceding article shall
include at least the following particulars:

1 Name, address, contact method of the reporting firm or

organization and name of the reporter.

2 Date of occurrence and date of finding of the serious adverse

event.

3 Product name in Chinese and license number or listing number

of the medical device.

4 Model or specifications and batch number of the medical

device.

5 Direct supply source and flow of the medical device; if

reporter is the end user organization where the adverse event
occurred, there is no need to report product flow.

6 Current status of the medical device in the occurrence of

serious adverse event.

7 Category and outcome of the adverse event.

8 Description of the adverse event occurrence.

The description referred to in Subparagraph 8 of the preceding

paragraph shall include the following particulars:

1 Region where the adverse reaction occurred, symptom, and

severity level.

2 Product problem.

3 Factors and processes that may result in serious injury.

4 Patient's follow-up treatment.

Article 5 Medical institutions shall report in accordance with Article 3

and notify with a copy to the medical device license holders or
firms that have completed the listing within the following
deadlines:

1 Paragraphs 1 and 2 of Article 2: within seven days from the

date of finding.

2 Paragraphs 3 to 6 of Article 2: within fifteen days from the

date of finding.

When filing the report set forth in the preceding paragraph,

medical institutions may request medical device firms to provide
relevant information on the reporting form; medical device firms
shall give their cooperation .

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Article 6 The reporting made by medical device license holders or firms

that have completed the listing in accordance with Article 3
shall be completed within fifteen days from the date of finding
for the events specified in Article 2.

Article 7 After completing the reporting set forth in the preceding

article, medical device license holders or firms that have
completed the listing shall voluntarily investigate and evaluate
the necessity for taking corrective and preventive measures and
the implementation content of corrective and preventive
measures.

Results of the investigation and evaluation in the preceding

paragraph shall be notified by the medical device license
holders or firms that have completed the listing to the central
competent authority or the commissioned agency, legal entity, or
organization referred to in Paragraph 1 of Article 3; provisions
of Article 3 shall apply mutatis mutandis to their method of
notification; if it is necessary to take corrective and
preventive measures, medical institutions that use the said
medical devices shall be notified of the measures.

Article 8 Medical device license holders or firms that have completed the
listing and medical institutions shall keep the contents of the
reporting of serious adverse events of medical devices, the
documents and information of investigation and evaluation as
well as corrective and preventive measures set forth in the
preceding article, and their retention period shall be at least
five years; if the license is transferred within five years, the
transferee shall continue to keep them within the said period.

Article 9 The central competent authority or its commissioned agency,

legal entity, or organization may request medical device firms
and medical institutions to provide patient or medical device
related documents and information on the serious adverse events
of medical devices; those being requested shall not evade,
impede, or refuse such request .

Article 10 Medical device firms and medical institutions shall collect,

process, or use personal data in accordance with the provisions
of the Personal Data Protection Act and its relevant
regulations.

Article 11 These Regulations shall be implemented on May 1, 2021.

Web site：Laws & Regulations Database of The Republic of China (Taiwan)

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