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Your knowledge database for EMC, Wireless, Product  Safety, Sustainability & Global Market Access updates and requirements.

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Medical Device Wireless Guidance for the FDA

General
November 15, 2018

          Tuesday 4th December 15:00-15:40      Online Free Webinar   The Webinar will deal with FDA requirements according to the  “FDA Wireless Guidance” dictates to medical equipment manufacturers to meet the submission of 510K.   AGENDA   FDA Wireless Guidance Introduction EMC for Radio standards vs. IEC 60601 requirements Radio […]

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EU – Product Safety guideline on the LVD Directive

CE
November 15, 2018

EU released “LVD 2014/35/EU – Guidelines on the application of the directive – August 2018” European Commission(EC) released Low Voltage Directive 2014/35/EU guidelines for electronical equipment designed for use within certain voltage limits. For additional details: LVD Guide August 2018   360Compliance provides Testing & Certification for type approval services and global market access in […]

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FCC SDoC Q&A – Procedures for authorizing an RF device using Suppliers Declaration of Conformity (SDoC) – Part I

General
November 13, 2018

  Question 1: My product has previously been placed on the market under the Declaration of Conformity (DoC) or verification rules; is it also required for the product to comply with the new Supplier’s Declaration of Conformity (SDoC) requirements? Answer 1: No, products that were subject to either the DoC or verification equipment authorization procedures […]

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EU – Product Safety guideline on the LVD Directive

Europe
November 12, 2018

EU released “LVD 2014/35/EU – Guidelines on the application of the directive – August 2018” European Commission(EC) released Low Voltage Directive 2014/35/EU guidelines for electronical equipment designed for use within certain voltage limits.   For additional details see: Low Voltage Directive 2014/35/EU Guidelines   360Compliance provides Testing & Certification for type approval services and global market access in 195 […]

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Paraguay approved the Technical Standard for Operation of Radio Frequency Identification Equipment (RFID), in the UHF Band (865 MHz – 868 MHz)

Global Market Access
November 12, 2018

National Telecommunications Commission (CONATEL) released Resolution Directorio No, 898/2018 approving the Technical Standard for Operation of Radio Frequency Identification Equipment (RFID), in the UHF Band (865 MHz – 868 MHz). This standard establishes the technical parameters and conditions required for the operation of RFID in the 865 MHz – 868 MHz UHF Band. For additional […]

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Brazil – Anatel released change in Renewal Procedure and RF tests to be enforced starting from September 28, 2018

Global Market Access
November 12, 2018

On Nov 7th ANATEL sent an official letter to OCDs with clarifications about EMC Test Procedures on Restricted Radiation Transceivers from Act 6.506/2018. Here is a brief explanation of the most important items from this letter: 1. Change into Renewal Procedure: According to Item 4 of this letter, ANATEL is exempting already approved products from […]

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Ukraine Updates Technical Regulations for LVD, EMC, and Machinery

Global Market Access
November 12, 2018

Ukraine Updates Technical Regulations for LVD, EMC, and Machinery. Decree №533 (July 4th, 2018) shows changes to the Technical Regulations on machinery, low-voltage electrical equipment, and electromagnetic compatibility.   Read more:  Ukraine Updates Technical Regulations    360Compliance provides Testing & Certifcation for type approval services and global market access in 195 countries. With proven expertise in […]

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CPSC – Recall Notifications – Overview of CPSC notifications on recalls in June 2018

Sustainability
November 12, 2018

Consumer Product Safety Commission (CPSC) recalls 15 batches of products in June 2018. There are 9 batches of Chinese products, accounting for 60%. Accompanying remedies (refund, replacement and repair) are taken for such notifications. As notified on the CPSC website, some customers have already got injured due to the potential hazards. So it is important […]

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