[5/7 更新] 新冠肺炎蔓延全球,對您的產品認證有什麼影響呢? Country / Region Actions Toward Coronavirus Pandemic [as of May 7]

德国莱茵tuv [5/7 更新] 新冠肺炎蔓延全球,對您的產品認證有什麼影響呢? Country / Region Actions Toward Coronavirus Pandemic [as of May 7]
2020年3月18日 | 市場准入

德國萊因 TÜV 匯總整理目前各國和地區發證單位的應對措施, 讓您信心在握![5/19更新] 

English Version

 

 

本文涉及國家和地區包括:

*2020/5/19 更新涉及國家和地區

中國大陸 Mainland China*

印度 India*

泰國 Thailand*

菲律賓 Philippines*

韓國 South Korea*

巴西 Brazil (ANATEL)

巴西 Brazil (INMETRO)

臺灣 Taiwan

海灣聯盟 GCC countries*

馬來西亞 Malaysia*

智利 Chile (SEC)

歐亞經濟聯盟 Eurasian Economic Union*

伊拉克 Iraq

科威特 Kuwait

塞爾維亞 Serbia

印尼 Indonesia

瑞士 Switzerland

以色列 Israel

沙烏地阿拉伯 Saudi Arabia

阿根廷 Argentina*

加彭 Gabon

盧安達 Rwanda

突尼西亞 Tunisia

南非 South Africa

哥倫比亞 Columbia*

越南 Vietnam

墨西哥 Mexico

阿爾及利亞 Algeria

奈及利亞 Nigeria

賴索托 Lesotho

辛巴威 Zimbabwe

尚比亞 Zambia

葉門 Yemen*

利比亞 Libya

阿拉伯聯合大公國 UAE

約旦 Jordan

黎巴嫩 Lebanon

卡達 Qatar

阿曼 Oman

巴林 Bahrain

世界衛生組織 (WHO) 3月11日正式宣佈,新冠肺炎進入「全球大流行」(global pandemic)。為了預防疫情進一步擴散,目前各國和地區發證單位採取不同的因應方案,德國萊因 TÜV專家精心為您匯總整理如下:

 

 

 

 

國家/地區

措施

期限

中國大陸

針對需要正本的案件 (如驗證申請書等),可先行在系統中以附件形式上傳電子(掃描) 檔,待疫情結束後3個月內補寄紙本檔案。

即日起,CQC總部暫緩境內人員的全部現場檢查活動,具體恢復時間根據疫情發展情況另行通知。境外客戶的現場檢查活動,委派符合資質的境外機構進行。對於已經進行的工廠檢查且需要進行整改的,CQC將延長整改時限至疫情解除後3個月。在疫情期間,CQC接受企業提交的整改資料,並對資料開展評定工作,但暫不進行現場檢驗活動。

自即日起至疫情解除前,對有效期滿或需監督審核維持的驗證證書,順延既有驗證證書有效期至疫情解除後3個月。對於受疫情影響停產而不能接受工廠檢查的企業所持有的驗證證書,驗證證書的暫停時限可延遲至疫情解除後3個月。

疫情解除後3個月

印度

因疫情尚未緩解,印度內政部 (MHA) 宣布封城延至5/31 (Lockdown4.0)。

4.0版本放寬公司營運單位於綠區和橘區可全面復工,但須申請同意後方可復工。紅區維持33% ,貨物運輸同3.0已解禁。

3/13至5/31

泰國

1.TISI暫停至疫區以及有14天隔離要求的國家/地區進行廠檢。

2.目前只可申請“批次證書“,不需進行廠檢,但仍需送樣至當地測試。

未定

菲律賓

封鎖期間延長至5月31日。封鎖期間暫停政府行政部門工作 (包括NTC)。

3/15-5/31

韓國

測試和驗證均可正常進行,廠檢部分影響如下:

KTC:實地廠檢已恢復正常

KTL:初次廠檢,則必須要完成實地廠檢後才能簽發KC證書,而針對部分疫情仍相對嚴重的地區的工廠,需按具體位置而定,可能無法及時安排而有些許延誤,但必須完成廠檢後才能發證。

KTR:廣東省內和上海市的實地廠檢已恢復正常,其他省市地區的實地廠檢仍暫停,部分省市地區繼續維持“先安排發證+工廠提供廠檢資料檔”的特殊處理方式。

視不同發證單位而定

巴西 (ANATEL)

1. 續證時若產品未有變更則不需測試,僅提供文件聲明即可。

2. 不需提供內部和外部照片。

3. 此例外程序僅對證書有限期至2020年6月30日前的證書有效。

僅對證書有限期至2020年6月30日前的證書有效

巴西 (INMETRO)

INMETRO發布第111號法令取代之前的第79號法令。對於每個項目(新認證,認證維護,或重新認證)111號法令允許在202011日至2020630日之間進行合格評定活動的新接受條件: 當客戶告知由於新冠肺炎流行而無法接收工廠檢查員或無法測試其產品時,德國萊因TUV巴西將根據製造商提供以及之前的文件(最新內部審核報告、管理評估報告、投訴處理、先前測試的結果) 進行風險評估分析。

基於風險評估分析,德國萊因TUV巴西將決定:

1.將工廠審核和測試的最長期限推遲6個月。在這種情況下,根據定期維護規則,客戶可能在下一個期間進行兩次獨立的評估活動(兩次工廠審核和兩次測試),或者

2.在製造商與德國萊因TUV達成協議並以技術可用性 (Skype或其他通信工具) 為條件的情況下,執行遠程工廠審核,並使用特殊的測試報告接受標准進行測試。

注意:風險評估分析將針對工廠審核,測試分別進行,並且僅在客戶要求評估項目情況後才啟動。

詳情請諮詢相應的德國萊因同事為您解說。

1/1至6/30

臺灣

今年度若後續工廠檢查屬「第一次後續工廠檢查」者,原則上視當地疫情狀況可延期進行工廠檢查,但仍須於今年度完成工廠檢查。

至2020年底

海灣聯盟

GSO已發佈在疫情期間針對G-mark證書的臨時措施,發證不受影響。

NA

馬來西亞

有條件行動限制令再度延長至6月9日。大型聚會仍然禁止,但多數公司已恢復正常辦公。

3/18至6/9

智利 (SEC)

智利當地繼續在家辦公,廠檢、會議,以及其他現場專業評估繼續暫停,直到有更新的通知。

未定

歐亞經濟聯盟

因疫情而放的俄羅斯全國公共假期已結束,各單位已陸續恢復正常辦公。

NA

伊拉克

封城與宵禁期間延長,直到有更新的通知。

未定

科威特

CITRA (通信與信息技術監管局) 暫時關閉至五月底。

至5/31

塞爾維亞

發證單位縮短上班時間,發證周期可能會受到影響。

未定

印尼

SDPPI:

  1. 關閉任何涉及面對面的活動,通過當地測試或文件評估提交的新案件仍可以透過SDPPI線上申請,但週期將受到影響。
  2. 針對正在進行中的案件,無論處於何種階段,都將被推遲到情況恢復正常之後。
  3. SDPPI關閉面對面的活動,因此影響到原始證書的寄送。SDPPI將寄送電子檔證書作為原始證書的替代品,該電子檔證書的功能與原件相同。

實驗室:

  1. 關閉任何涉及面對面的活動。針對正在進行中的案件,無論處於何種階段,都將被推遲。
  2. 將寄送電子檔測試報告作為原件的替代品。

未定

瑞士

疫情期間ESTI員工在家辦公,發證周期預估將延遲約一周左右。

未定

以色列

因為疫情關係以色列的上班時間有改變,並且SII目前正在以減少的人力進行工作,導致SII的發證周期延誤。

未定

沙烏地阿拉伯

持續封城狀態,多數員工仍在家辦公,直到有更新的通知。

未定

阿根廷

多數發證流程已接近正常。

NA

加彭

ARCEP暫時關閉。

未定

盧安達

提供在線服務,審查員可以在家工作,預計服務將繼續而不會延遲。

未定

突尼西亞

海關優先考慮與疫情有關的設備,因此寄送到突尼西亞的樣品將卡住。 另外,CERT目前關閉,正在進行的申請將被延遲。

未定

南非

逐步解除封城。

NA

哥倫比亞

封城延至5月25日,但有部分商業活動已開啟,發證時間預期暫時受影響。

3/24至5/25

越南

正常工作不受影響。

NA

墨西哥

1.由於實驗室人員減少,TUV萊因墨西哥通知發證周期將延長兩週。

2.IFT  (Federal Telecommunications Institute) 停止現場專業評估至5月30日,其他活動將儘量以電子方式執行。

3. ANCE人員居家辦公,實驗室人員減少並且案件滿載,故測試與發證周期將延長。

1. 未定

2.至5/30

3. 未定

阿爾及利亞

ARPCE目前關閉;ANF仍正常運作。

未定

奈及利亞

NCC減少上班人員至最低限度。 NCC仍然提供在線服務,但是預計發證流程會放慢。

未定

賴索托

LCA賴索托宣布縮減營運規模。 儘管LCA通過電子通訊繼續工作,但發證時間預計會拉長。

未定

辛巴威

Potraz 於3月26日開始在家辦公,預計發證時間會延長。

未定

尚比亞

ZICTA開始在家辦公,預計發證時間將受影響。

未定

葉門

葉門MTIT目前關閉。

未定

利比亞

利比亞管理局每周僅以有限的員工工作兩天,預計發證時間將會延遲。

未定

阿拉伯聯合大公國

在家辦公,直到有更新的通知。

NA

約旦

全國封鎖期間延長至4月30日,案件交期將會受到影響。

3/26至4/30

黎巴嫩

持續封城狀態,直到有更新的通知。

未定

卡達

在家辦公,直到有更新的通知。

未定

阿曼

在家辦公,直到有更新的通知。

未定

巴林

正常工作

NA

除此之外,世界各地另有多個國家和地區要求境內商店關閉,公司員工在家辦公,並進行邊境管制,因而在發證週期以及回覆諮詢方面可能會有延遲滯後的影響。面對這些影響,德國萊因 TÜV將善用自身豐富的經驗和全球網路資源與客戶共同面對和克服,急客戶所急, 力求將此次新冠肺炎疫情對客戶案件的影響減至最低。

德國萊因TÜV擁有遍佈全球的強大驗證網路及技術資源, 在非常時期我們將調用一切資源為客戶真正做到「省時、省力、省心」。 選擇德國萊因 TÜV, 時刻掌握全球驗證動態, 讓您信心在握!

※  此版本為截止至2020/5/19之更新訊息,若有最新消息將持續於德國萊因部落格發布。

 

Country/ Region Actions Toward Coronavirus Pandemic

 

 

 

 

 

 

Country / Region

Action

Period

Mainland China

1.Documentation:

For documents that require original documents (e.g. certification applications, etc.), the applicant can upload an electronic version (scan copy) in the form of attachments in the system, and documents in hard copies should be re-posted within 3 months after the end of the outbreak.

2.Factory Inspections:

As of now, the headquarters of CQC has suspended all on-site inspection activities carried out by personnel in China. The restart time will depend on the epidemic situation, and notification will be provided. For on-site inspections for overseas customers, CQC will entrust implementation to overseas institutions.

For factory inspections that have been carried out that result in required corrections, CQC will extend the time limit for corrections to 3 months after the epidemic is over.

3.Certificate Validity:

From now on until the outbreak is over, the validity of a certificate that has expired or needs to be supervised shall be extended until 3 months after the outbreak is over.

For certificates held by enterprises that are affected by the outbreak and which cannot accept factory inspections, the suspension time limit for a certificate can be extended until 3 months after the outbreak is over.

3 months after the end of the outbreak

India

Extend lockdown till May 31 (Lockdown4.0).

March 25 till May 31

Thailand

1.TISI stopped all staff from traveling to countries affected by the epidemic (both vacation and business). TISI has also stopped all staff from traveling to countries that have a 14-day quarantine regulation.

2. Currently the client can only apply “Shipment Certificate” as a temporary solution. No factory inspection for Shipment Certificate, but sending samples for local testing is still required.

Not yet decided

Philippines

Nationwide lockdown is extended till May 31.

 March 15 till May 31

South Korea

Testing and certification can be carried out normally. The impact of factory inspections is as follows:

KTC: On-site factory inspection is back to normal.

KTL: For factories applying for the first time, it is still necessary to go through the factory inspection before the issuing of a KC certificate. For factories located in provinces or regions with more severe epidemic condition, depending on the specific location, some delay of factory inspections may occur. However, the certificate can still only be issued after the factory inspection is conducted.

KTR: On-site factory inspection is back to normal in Guangdong Province and Shanghai City. For other provinces and areas it is still suspended. KTC accepts the special processing method of issuing a certificate after submitting all the inspection materials of the factory.

Dependent on different certification bodies

Brazil (ANATEL)

1) No renewal testing will be required for devices that have not undergone any change in project/components compared to the previous renewal/certification.

2) Internal and External photos will not be required.

3) These exceptions are valid only for certificates expiring prior to June 30, 2020.

Valid only for certificates expiring until June 30, 2020

Brazil (INMETRO) For Inmetro projects the Ordinance 111/2020 allows new acceptance conditions for the conformity assessment activities between January 1st 2020 to June 30th 2020 as follows:

For each project: new certification, certification maintenance (surveillance) and recertification, when clients inform they cannot receive Factory Inspectors or cannot test their products due to COVID-19 epidemic, TÜV Rheinland Brazil will prepare a Risk Assessment Analysis considering the documentation provided by manufacturer and from previous projects as follow:

Documentation arranged by manufacturer:

  1. Latest Internal Audit Report: according to item 9.2 of ISO 9001 or 8.2.4 of ISO 13485
  2. Management Review Report: according to item 9.3 of ISO 9001 or 5.6.1 of ISO 13485

Documentation from previous projects:

  1. Complaints Handling: in this case we will use the last CCS (Customer Complaint Service) Audit Report done at the importer (Brazilian License Holder);
  2. Results from previous tests: only applicable for maintenance and recertification projects

Based on the Risk Assessment Analysis, TÜV Rheinland Brazil will decide:

  1. Postpone for a maximum period of 6 months the Factory Audit and Tests. In this case the client may have 2 independent evaluation activities in the next period (2 factory audits and 2 tests) depending on the periodic maintenance rules or;
  2. Perform remote factory audit, when agreed between manufacturer and TÜV and conditioned to technical availability (Skype or other communication tool) and perform Tests with exceptional Test Report Acceptance Criteria.

Note: the Risk Assessment Analysis will be performed for factory audits and tests separately, and only initiated after client request to evaluate the project situation.

Please contact TUV Rheinland colleagues for more details.

January 1 till June 30

Taiwan

If a follow-up factory inspection within this year is the “first follow-up factory inspection,” depending on the local epidemic situation, the factory inspection can be postponed, but the factory inspection must still be completed within this year.

Till end of 2020

GCC Countries

GSO has issued temporary measures against the G-mark certification during the outbreak, and the issuance of the certificate will not be affected.

NA

Malaysia

The Conditional Movement Control Order is extended till June 09. Large-scale gatherings are still prohibited, but most companies have resumed normal office work

March 18 till  June 9

Chile (SEC)

The suspension of local inspections, meetings, and other on-site professional evaluations in Chile keep going, until there is further notice.

Not yet decide

Eurasian Economic Union

Russia’s national-off against COVID-19 is over. Most companies have resumed normal work

NA

Iraq

Lockdown and curfew is extended till till further notice is issued.

Not yet decided

Kuwait

CITRA (Communication and Information Technology Regulatory Authority) is temporarily closed till the end of May.

Till end of May

Serbia

Kvalitet has shortened working hours. Certification lead-time may be affected.

Not yet decided

Indonesia

SDPPI:

1. All face-to-face activities are prohibited. Submission of new applications through local testing or document evaluation can still be accepted through the SDPPI portal, but the lead-time will be affected.

2. For ongoing projects, no matter what stage a project is now in, it will be postponed until the outbreak is relieved.

3. SDPPI has shut down face-to-face activities, thus affecting the delivery of original certificates. A temporary digital certificate will be sent as replacement of the original certificate, which has the same function as the original version.

Labs:

1. All face-to-face activities are prohibited. Ongoing projects, no matter what stage a project is now in, will be postponed.

2. A temporary digital test report will be sent as replacement of the original version.

Not yet decided

Switzerland

ESTI employees are working from home during the pandemic. Lead-time for issuing Authorization is expected to be delayed by about one week.

Not yet decided

Israel

Due to the epidemic situation, the working hours in Israel have changed. SII is currently working with reduced manpower, which has led to the delay of the SII certification lead-time.

Not yet decided

Saudi Arabia

Lockdown keeps going. Most people are working from home, until there is further notice.

Not yet decided

Argentina

Most of the certification operation is back to normal.

NA

Gabon

ARCEP is temporarily closed.

Not yet decided

Rwanda

Rwanda offers online services and reviewers are able to work from home. Service is expected to continue with no delay.

Not yet decided

Tunisia

Tunisia customs are giving priority to equipment related to the pandemic. Therefore, samples sent to Tunisia will get stuck for a certain time. Also, CERT is currently shutdown; ongoing applications will be delayed.

Not yet decided

South Africa

Enter lockdown level 4; some business is now permitted.

NA

Colombia

Lockdown is extended till May 25. TUV Rheinland Colombia colleagues are working from home; certification lead-time and inquiry services are a bit affected.

March 24 till May 25

Vietnam

Work normally

NA

Mexico

1.Labs reduce on-site staff; therefore, the certification lead-time is expected to increase for 2 more weeks.

2.IFT  (Federal Telecommunications Institute) stops on-site activities till May 30. Other activities will be performed electronically as much as possible.

3.ANCE staff are working from home. Labs reduced on-site staff and is working fully loaded now. Testing and certification lead-time is expected to be longer.

1.Not yet decided

2.Till 5/30

3.Not yet decided

Algeria

ARPCE is currently shutdown; ANF is still working.

Not yet decided

Nigeria

Nigeria is taking measures to limit staff to strict minimum. NCC still offers online service for type approval submissions, but delay of certification lead-time is expected.

Not yet decided

Lesotho

LCA Lesotho announced the scale down of operations. While works continue by means of electronic communications, longer lead-time is expected.

Not yet decided

Zimbabwe

Zimbabwe Potraz started work from home on March 26th. Longer lead-time is expected.

Not yet decided

Zambia

Zambia ZICTA activated work from home. Certification lead-time may be affected.

Not yet decided

Yemen

Yemen MTIT is currently closed.

Not yet decided

Libya

Libya Authority is working with limited staff two days per week only. Delays are expected.

Not yet decided

UAE

Work from home until further notice.

NA

Jordan

Nationwide lockdown is extended till April 30. Certification lead time will be affected

3/26 till 4/30

Lebanon

Lockdown is extended till till further notice is issued.

Not yet decided

Qatar

Most staff are working from home till till further notice is issued.

Not yet decided

Oman

Most staff are working from home till till further notice is issued.

Not yet decided

Bahrain

Working normally

NA


As of May 19, 2020

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