REGULATORY NEWS

India Changes Testing Procedure for R&TTE Products

To receive TEC certificate, the procedure of Mandatory Testing and Certification Of Telecommunication Equipment (MTCTE) in India requires testing to be carried out by TEC accredited labs. This requirement is governed by the Indian Telegraph (Amendment) Rules. As a temporary procedure to modify this requirement, it was decided to issue the Addendum TEC/10/2018-TC to the TEC/MP/DD/TCP-711/02 “Procedure for MTCTE” in July 2019. According to this Addendum, the TEC is able to accept test results /reports from the labs that are accredited by ILAC signature. Such relaxation of the rules was acceptable up to March 31st, 2020. Recently, the TEC decided to revise the provision of the Addendum TEC/10/2

India Launches Phase II Certification Procedure for Telecommunication Devices

In India, the testing and certification procedure of telecommunication equipment is governed by the Indian Telegraph (Amendment) Rules, 2017. According to these rules, every telecom equipment must fall under mandatory testing and certification procedure prior to being sold, imported or used in India. The TEC certificates can be issued only based on test results issued by Indian Accredited labs. Telecommunication Engineering Centre (TEC), New Delhi, under the Department of Telecommunications (DoT) issued a set of essential requirements and notifications to implement the statements of the Indian Telegraph (Amendment) Rules. First of all, the detailed procedure for Mandatory Testing and Certifi

China Issues Some Amendments in Medical Device Regulation Procedure

The Center for Medical Device Evaluation of China (CMDE) issued two announcements in early June. These announcements relate to the medical device registration: Announcement No 16 of 2020 Announcement No 42 of 2020 According to the Announcement No 16 of 2020, after receiving the set of documents from the applicant, the authorization body starts to check it in accordance with the file examination requirements. If it requires correction, the applicant has the opportunity to correct the documents within this first submission. When resubmitting, it is necessary to follow the relevant requirements to associate the previous registration with the amendments. Otherwise, it will be considered as a new

Brazil Updates Technical Requirements for R&TTE Devices

In the light of 5G technologies development, more and more companies produce devices that can operate in the fifth generation technology standard for cellular networks (5G). This prompted Brazilian ANATEL to work out technical requirements for the applicable devices. On June 12, 2020, ANATEL published three Acts that contain minimum requirements with regard to quality, safety, compatibility, and protection of the radio spectrum applied to devices operating in 5G network. These Acts concern Terminal Stations, Mobile Cellular Phones and Transceivers for Radio Base Stations, namely: Act 3151 “On technical requirements for conformity assessment procedure of Terminal Station access point” Act 315

USA Determines Toys Fibers exempted from Third-Party Testing

The US Consumer Product Safety Commission (CPSC) issued a final document that determines which unfinished manufactured fibers do not contain the ASTM F963 elements or specified phthalates with the consent limits for children's toys and child care articles. Here it is eight “ASTM F963 elements” and their limits of solubility: The following phthalates are prohibited for sale, distribution in commerce, or importation into the United States as part of any children's toy or child care article if their concentration exceed 0.1 percent of: di-(2-ethylhexyl) phthalate (DEHP) dibutyl phthalate (DBP) benzyl butyl phthalate (BBP) diisononyl phthalate (DINP) diisobutyl phthalate (DIBP) di-n-pentyl phtha

United Arab Emirates Adopts New Requirements for Vehicles

Emirates Authorities for Standardization and Metrology reminds vehicle manufacturers and traders on the requirements for eCall system in vehicles. According to the UAE cabinet decree No. (13)/ 2018, all new vehicle models must be equipped with an eCall system starting from 2021. The requirements for the eCall system are based on the UAE.S 5019:2018 and relate to new light motor vehicles that do not exceed 3.5 ton and have up to 9 seats, including driver's seat. However, if the vehicles are manufactured in the small series (less than 75 vehicles annually), the eCall requirements are not applicable to them but it is still necessary to receive ESMA certificate of conformity. There is a choice w

Paraguay Issues New Textile Labeling Regulation

The Ministry of Industry and Commerce of Paraguay issued a new Decree 3383 dated by 2020 which approves new textile labeling requirements. According to this Decree, the resolution of the common market group of MERCOUSUR # 62/18 "MERCOSUR technical regulation on labeling of textile products" is incorporated into the national legal order of Paraguay. MERCOSUR is a South American trade block comprising of Argentina, Brazil, Paraguay and Uruguay. It was created to promote free trade and the free movement of goods, people, and currency. Considering that, it is important for the parties to have a harmonized Technical Regulation on the labeling of textile products in order to facilitate free trade.

Argentina Clarifies Situation with Approval Procedure

In the context of the epidemiological situation, which affects all countries, the National Communications Entity of Argentina (ENACOM) issued Resolution No. 326/2020 in April 2020. According to this resolution, ENACOM implemented temporary measures to extend the validity of certain approvals which have an expiry date between March 16, 2020 and May 16, 2020. The approvals are prolonged by a period of 60 calendar days from the expiration date, because of the mandatory lockdown from March 20 until April 12 in Argentina. Recently, ENACOM issued another Resolution 471/2020 that modifies article 2 of the Resolution No. 326/2020 and extends once again the expiration date of certificates. It says th

Uzbekistan Implements Interactive Conformity Assessment Procedure

GMA Consult Group is pleased to announce that Uzstandard agency is adopting an interactive conformity assessment procedure. The Uzstandard has been included in the Unified portal for interactive public services and will soon issue certificates of conformity via the portal. After passing the conformity assessment procedure, an applicant will receive a QR-code and will be able to review the certificate on the portal through this code. Thus, identification of certified products will be implemented through QR-codes and will no longer support paper documents. This new mechanism has been worked out based on the Decision of the President of the Republic of Uzbekistan No. PP-4059. It is aimed to im

Vietnam Updates List of Products Subject to Type Approval

The Ministry of Information and Communications (MIC) of Vietnam issued Circular No. 11/2020/TT-BTTTT. This document concerns products subject to MIC Type Approval Certification and Declaration of Conformity. It replaces Circular No. 05/2019/TT-BTTTT and makes amendments in the list of products category 2 subject to MIC certification and declaration of conformity. The circular includes two annexes. The first one consists of R&TTE products that are subject to both certification and declaration and contains 3 categories of the products. The second covers six categories of R&TTE products and their components that fall under the declaration of conformity procedure. The new document will come into

India Establishes Requirements for Quality Control of Toys

India published an Order on the toys quality control. The document concerns requirements for toys and materials used for their manufacturing, which are intended for children under 14 years old. Such products or materials should comply with the national Indian standards according to the table below: Please note that it is necessary to use the latest version of the standards including the amendments issued thereof. Once the product proves the compliance with the requirements of the relevant standards, the Standard Mark under a licence from the Bureau of Indian Standards should be beared. Additionally, for imported products, the manufacturer should provide Certificates of Conformity as the evid

Oman Is About to Implement New RoHS Requirements

The Telecommunications Regulatory Authority (TRA) of Oman is going to implement new Restriction of Hazardous Substances (RoHS) requirements. The implementation of the new rules is planned for the end of June, 2020. Thus, new radio and telecommunications terminal equipment that is subject to the type approval procedure will also have to show its compliance with RoHS requirements. The RoHS requirements are based on the EU Directive 2017/2102 that amends Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment. RoHS restricted substances and their maximum concentration values tolerated by weight in homogeneous materials include: c

Indonesia Clarifies Certification Procedure During the Pandemic

SPPI of Indonesia issued a Circular “On application for certification procedure of telecommunication devices in the COVID-19 period” on May 20, 2020. The document is aimed at clarifying the certification process of telecommunication equipment with regard to test reports requirements during the COVID-19 period. According to the Circular, every Telecommunication Device that is made, assembled, or marked on the territory of the Unitary Republic of Indonesia must be certified and the already-certified products must pass the recertification procedure every 3 years. To apply for a new certificate, it is necessary to provide test result reports or test reports to the equipment. In case the applican

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