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The FDA recently launched a new website, AccessGUDID, to provide public access to their Global Unique Device Identification Database (GUDID) which contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI).  The FDA is establishing this unique device identification system to adequately identify devices sold in the U.S.- from manufacturing through distribution to patient use.

The website is currently in beta version and the FDA is requesting feedback on functionality and contents from users (healthcare providers, patients and researchers). Currently, only data for Class III and high-risk devices can be found on the site but additional device types and classifications will be added to GUDID through 2020.

Please contact Rhein Tech if you have any questions or testing requirements. 703.689.0368

India's Department of Electronics and Information Technology (Deity) recently announced they are postponing the implementation date of the BIS requirement for the following products until August 13, 2015  (previously the implementation date was April 15, 2015):

  • External power adapters
  • Mobile phones is expected to be wide and include many enterprise products that support cell phone technology/functionality.

Please contact Rhein Tech if you have any questions or testing requirements. 703.689.0368

As of May 11, 2015, South Africa's Bureau of Standards (SABS) has suspended its services pending an internal preliminary investigation of non‐compliance in its processes and procedures.  SABS had recently received a complaint purporting that the necessary due diligence was not followed in terms of SABS processes and procedures. In line with SABS policy, an internal investigation is currently in progress to review the allegations.  In order to enable an objective investigation, employees involved in the process of delivering the service have been placed on precautionary suspension pending investigation. No charges have been made at this stage and no details are available.  

During April 2015, the European Commission published the following updated list of standards in the Official Journal of the European Union to be used for assessing compliance. 

Please contact Rhein Tech if you have additional questions or testing requirements. 703.689.0368

We were recently advised by our local agent that Malaysia's 5470-5650MHz band has been opened for use by Short Ranges Devices. 

Please contact Rhein Tech if you have any questions or testing requirements. 703.689.0368

 

Nambia's Type Approval Authority (CRAN) implemented new mandatory Type Approval requirements which were scheduled to go into effect on August 3, 2015. That date has now been extended to November 30, 2015.  These new requirements apply to all radio telecommunication equipment for importation and sale, without exemption. The Authority will accept R&TTE test reports and samples are not required (but may be requested during appliation review).  There is no requirement for a local signatory; foreign manufacturers are able to obtain Type Approval certificates issued in their name and the certificate is valid for three years.   Equipment currently on the market in Nambia must go through this process prior to the November 30, 2015 deadline or may be confiscated by the Nambian Authority.  

Please contact Rhein Tech if you have additional questions or testing requirements. 703.689.0368

On April 17, 2015, the European Commission published an updated list of standards in the Official Journal to be used for assessing compliance to the R&TTE Directive.  

Please contact Rhein Tech if you have additional questions or testing requirements. 703.689.0368

New Zealand's Radio Authority recently published Radiocommunications Regulations (Radio Standards) Notice 2015 which describes the performance standards required to be met by different classes of radio product and the unwanted emission power limit for any transmitter not covered by those standards. Additionally, limits of unwanted emissions are specified for Low Power FM transmitters. The notice also assigns the level of conformity applying to the products covered by each standard.

Please contact Rhein Tech if you have any questions or testing requirements. 703.689.0368

The FCC has scheduled an Open Meeting on the subjects listed below for Thursday, May 21, 2015. The meeting is scheduled to begin at 10:30 a.m. (Room TW-C305, at 445 12th Street, W., Washington, D.C.).  Additionally, the meeting will be shown live at FCC.gov/live.  Topics discussed will include the following:

  •  Accessible Emergency Information: The Commission is expected to consider a proposal to extend accessibility rules for emergency alerts to "second screens," including tablets, smartphones, laptops, and similar devices. The Second Report and Order and Second Further Notice of Proposed Rulemaking would take additional steps to make emergency information in video programming accessible to individuals who are blind or visually impaired.
  • Extend and Make Permanent 'iCanConnect' Program: The Commission is expected to consider an Order to extend the National Deaf-Blind Equipment Distribution Program and consider a Proposed Rulemaking to permanently extend the program. The program provides up to $10 million annually from the Interstate Telecommunications Relay Service Fund to support programs that distribute communications equipment to low-income individuals who are deaf-blind.

 

US - FCC Opens 3.5 GHz Band

Posted on April 22nd 2015 by

On April 17, 2015, the FCC voted to adopt new spectrum sharing tools and policies to make 150 MHz of spectrum available for mobile broadband and other commercial uses. The 3.5 GHz band was previously locked up by the U.S. Department of Defense (DoD).

The band is seen as ideal for small cells, but FCC staff also has said it's possible that new, as-yet-unforeseen uses for the band will emerge; hence, it's referred to as the "innovation band." The FCC has been working on rules to open the band for more than two years.

The new spectrum sharing techniques include a three-tiered approach spanning 3550 MHz to 3700 MHz, for a service dubbed the "Citizens Broadband Radio Service." The FCC says use of advanced spectrum sharing technology will allow wireless broadband systems to share spectrum with military radars and other incumbent systems while protecting federal missions.

Please contact Rhein Tech if you have additional questions or testing requirements.  703.689.0368

On April 13, 2015, the FCC published draft 935210 Signal Boosters DR07-42107 for comment.  The draft updates two attachments to the publication:  (1) 935210 D02 Signal Booster Certification v02r01, (2) 935210 D03 Signal Booster Measurements v02r01, and adds a new attachment 935210 D05 Indus Booster Basic Meas v01 to replace annex D in the current 935210 D02 Signal Booster Certification v02r01.

Please contact Rhein Tech if you have additional questions or testing requirements. 703.689.0368

 

Costa Rica's Type Approval Authority, SUTEL, now requires that each model has its own certificate while previously, family approvals were allowed. Any difference between models, such as color, hardware, or software, will require separate Type Approval certificates.

Mexico's medical device market regulator, COFEPRIS, recently added 573 items to its list of products not considered medical devices, effectively removing registration as a requirement for importation, distribution or sale of these products in Mexico. Most of the products added to the no-registration list share low-risk profiles, or are components or accessories to other medical devices. Most notably, standalone software remains on the list of products not required to be registered with COFEPRIS.

Please contact Rhein Tech Laboratories, Inc. at 703.689.0368 or sales @ rheintech.com for additional information. 

The Malaysian Communications and Multimedia Commission (MCMC) and its appointed Certifying Agency, SIRIM, launched a Self-Labelling Program (SLP) on February 24, 2015. This program will be fully implemented beginning June 1, 2015 and will replace the conventional labeling program (physical label).

The SLP is for certified communication products whereby the certificate holder or manufacturer self-labels their certified products according to related guidelines and procedures. The SLP is the certification mark with the following information for the certified product:

i. The logo design
ii. The word "MCMC"
iii. Unique ID, i.e. Common ID (CID) or Certificate Holder ID (HID)

The certification mark is presented on the product through the methods of

e-Labelling or Surface-Labelling, depending on the suitability of the product's design.

During March 2015, the R&TTE Compliance Association issued TGN 21 Guidance for Report Checking – Information Validity and Integrity. The guidance is intended to help Notified Bodies confirm the integrity and validity of test reports submitted by agents, manufacturers or test laboratories with which the Notified Body does not have consistent experience. 
To find out more, please contact Rhein Tech Laboratories, Inc. at sales @ rheintech.com or call us at 703.689. 0368.
 
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