【轉知】CDC重申設置單位輸出入感染性生物材料及傳染病檢體，應依傳染病防治法及感染性生物材料管理辦法等規定，向衛生福利部疾病管制署申請許可後，始得為之。

一、依據衛生福利部疾病管制署115年10月21日疾管感字第1150005610A號函辦理。
二、設置單位輸出入感染性生物材料或傳染病檢體，依傳染病防治法（以下簡稱傳防法）第34條第2項及感染性生物材料管理辦法（以下簡稱管理辦法）第19條第1項規定，應取得中央主管機關核准後，始得為之，先予敘明。
三、鑑於邇來屢有相關設置單位或生物科技公司，因未依規定於輸出入感染性生物材料前申請許可而受罰，爰請協助轉知所轄設置單位，於輸出入感染性生物材料或傳染病檢體前，應確實依據貨品內容物之性質申請許可，如經查獲確有申報不實或未予申請之情事，疾病管制署將視情節輕重，依傳防法第64條第1項第5款規定，酌予裁處新臺幣9萬元以上45萬元以下罰鍰；違規輸出入之品項，並依其查獲時機及對公眾安全影響程度，要求銷毀、退運或補行程序。
四、旨揭感染性生物材料，依傳防法第4條第4項規定，指具感染性之病原體或其衍生物，及經確認含有此等病原體或衍生物之物質。其中有病原體衍生物，依管理辦法第2條第11項規定，指病原體經純化、分離之核酸、質體、蛋白質或其他組成成分。又傳染病檢體，依傳防法第4條第5項規定，指採自傳染病病人、疑似傳染病病人或接觸者之體液、分泌物、排泄物與其他可能具傳染性物品。
五、疾病管制署受理之感染性生物材料範疇，依據「感染性生物材料暨傳染病檢體輸出入管理規定」（以下簡稱輸出入規定），於病原體部分，為衛生福利部感染性生物材料管理作業要點（以下簡稱作業要點）附表1至附表4所列病原體，以及未列表但有文獻顯示曾造成人類感染、疾病或來源從人體身上分離者；於病原體衍生物部分，為上述病原體經純化、分離之核酸(DNA、RNA)、質體(Plasmid)、蛋白質或其他組成成分，包括來源為E coli.(列為作業要點附表一第78項)之質體，或是源自作業要點附表列管病原體之限制酶(Restriction Enzyme)、聚合酶(Polymerase)…等。
六、另對於人類細胞株不含有病原體或病原體衍生物、且目的為研究用途者，疾病管制署提供簽審機關免證專用代碼「DHK99999999999」，以簡化是類品項輸出入申請程序。不符前開定義之輸出入品項，不得使用該專用代碼，如經查獲申報不實，疾病管制署得依法進行裁處。又輸出入品項如為含有病原體或病原體衍生物之人類細胞株，請依輸出入規定，以「研究用試劑」類別向本署提出申請。
七、疾病管制署製有「感染性生物材料輸出入規定與實務解析」簡報，併同感染性生物材料輸出入申請相關規定與作業流程等，掛置於疾病管制署全球資訊網（網頁：疾病管制署首頁＞申請＞感染性生物材料輸出入申請＞作業規定與流程），請多加利用。

1. This announcement is issued in accordance with the official letter from the Centers for Disease Control (CDC), Ministry of Health and Welfare, dated October 21, 2026, with reference number CDC-Infectious-1150005610A.

2. Please be advised that, pursuant to Article 34, Paragraph 2 of the Communicable Disease Control Act (hereinafter referred to as the "Act") and Article 19, Paragraph 1 of the Regulations on the Management of Infectious Biological Materials (hereinafter referred to as the "Regulations"), any establishment involved in the import or export of infectious biological materials or infectious disease specimens must obtain prior approval from the central competent authority.

3. In light of recent instances where relevant establishments or biotechnology companies have been penalized for failing to apply for permits before importing or exporting infectious biological materials, we request your assistance in notifying the establishments under your jurisdiction. Prior to the import or export of infectious biological materials or infectious disease specimens, applications for permits must be submitted based on the specific nature of the contents. Should any instances of false reporting or failure to apply be discovered, the CDC will impose fines ranging from NT$90,000 to NT$450,000 in accordance with Article 64, Paragraph 1, Subparagraph 5 of the Act, depending on the severity of the violation. Furthermore, the non-compliant items will be subject to destruction, return to the country of origin, or mandatory remedial procedures, depending on the timing of discovery and the potential impact on public safety.

4. According to Article 4, Paragraph 4 of the Act, "infectious biological materials" refer to infectious pathogens or their derivatives, as well as substances confirmed to contain such pathogens or derivatives. Furthermore, pursuant to Article 2, Paragraph 11 of the Regulations, "pathogen derivatives" refer to nucleic acids, plasmids, proteins, or other components purified or isolated from pathogens. Additionally, according to Article 4, Paragraph 5 of the Act, "infectious disease specimens" refer to body fluids, secretions, excretions, and other potentially infectious materials collected from patients, suspected patients, or contacts of communicable diseases.

5. The scope of infectious biological materials accepted by the CDC, as defined by the "Regulations on the Import and Export of Infectious Biological Materials and Infectious Disease Specimens" (hereinafter referred to as the "Import/Export Regulations"), includes: (1) Pathogens listed in Tables 1 through 4 of the "Operational Guidelines for the Management of Infectious Biological Materials" (hereinafter referred to as the "Operational Guidelines"), as well as pathogens not listed but documented in literature as having caused human infection or disease, or isolated from humans; (2) Pathogen derivatives, including purified or isolated nucleic acids (DNA, RNA), plasmids, proteins, or other components derived from the aforementioned pathogens, such as plasmids from E. coli (listed as Item 78 in Table 1 of the Operational Guidelines), or restriction enzymes and polymerases derived from pathogens listed in the Operational Guidelines.

6. For human cell lines that do not contain pathogens or pathogen derivatives and are intended for research purposes, the CDC provides a dedicated exemption code "DHK99999999999" to simplify the import and export application process. This code must not be used for items that do not meet the aforementioned definition; any false reporting discovered will be subject to legal penalties. However, if the imported or exported items are human cell lines containing pathogens or pathogen derivatives, applications must be submitted to the CDC under the category of "Research Reagents" in accordance with the Import/Export Regulati