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[国際規制情報] 新型コロナウイルス感染症の影響による、各国認証当局、認証機関の動向・情報(2020年5月19日付、英語)

Posted by TUV Rheinland Japan on 2020/05/19 12:25:00
TUV Rheinland Japan

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新型コロナウイルス感染症により、各国認証などに影響が出ています。認証当局、認証機関の情報をお知らせいたします(2020年5月19日付)。

※海外からの情報のため、英語での掲載とさせていただきます。

As of May 19, 2020

Corona pandemic - Information for Customers of TÜV Rheinland Market Access Services
The current situation of local certification bodies / authorities

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:

  • Latest Internal Audit Report: according to item 9.2 of ISO 9001 or 8.2.4 of ISO 13485
  • Management Review Report: according to item 9.3 of ISO 9001 or 5.6.1 of ISO 13485
Documentation from previous projects:
  • Complaints Handling: in this case we will use the last CCS (Customer Complaint Service) Audit Report done at the importer (Brazilian License Holder);
  • Results from previous tests: only applicable for maintenance and recertification projects
Based on the Risk Assessment Analysis, TÜV Rheinland Brazil will decide:
  • 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;
  • 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  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 further notice is issued.

Not yet decided

Qatar

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

Not yet decided

Oman

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

Not yet decided

Bahrain

Working normally

NA

 

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Topics: 国際規制情報, tuv.communication, regulations-and-standards