Brazil

BRAZIL (ANVISA) – NOTIFICATION OF CLASS I MEDICAL DEVICES

Effective May 2, 2019

Brazil National Health Surveillance Agency (ANVISA) published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with Class I medical devices (materials, equipment and IVD products). RDC 270/2019 amends RDCs 36 and 40/2015.

The regulation of Class I medical devices has been done through the cadastro process. Under the new Resolution, the lowest risk products will be regulated through notification as a simplified system in which there will be no prior technical analysis of the petitions. The publication of the notification is expected within 30 days following the notification’s application and the payment of the ANVISA fee. Only after the granting of the notification number can the product be industrialized or commercialized.

BRAZIL (ANATEL) – UPDATED TECHNICAL REQUIREMENT AND TESTING PROCEDURES FOR TELECOMMUNICATIONS EQUIPMENT

 Effective January 11, 2019

 National Telecommunications Agency (ANATEL) updated the list of Technical Requirements for Telecommunications Products, Category II. The scope of Category II equipment is not included in the definition of Category I, which uses radio spectrum for signal transmission (e.g. antennas, equipment with Wi-Fi interfaces, Bluetooth, etc.) The update also adds the requirements and procedure references for fixed, mobile and portable transceivers and transmitters.

BRAZIL (ANATEL) – PUBLIC CONSULTATION Nº 6/2019

Proposed date of entry into force: To be determined

ANATEL is requesting comments and suggestions from the Brazilian society about revoking the antennas regulations, not being mandatory to certify Point to Point, Point to Multi-Point and Earth Station antennas.

Details of the public consultation can be viewed here:

View Details of the public consultation (Brazil).

Canada

CANADA (ISED) – PUBLIC CONSULTATION RSP-100, ISSUE 12

 Proposed date of entry into force: To be determined

 Notice was given by the Ministry of Innovation, Science and Economic Development Canada (ISED) that the document “RSP-100, Issue 12, Certification of Radio Apparatus and Broadcasting Equipment” has been posted on the Radio Advisory Board of Canada (RABC) for a 70-day consultation period.

RSP-100, Issue 12, Certification of Radio Apparatus and Broadcasting Equipment, sets out the certification procedure for radio apparatus and broadcasting equipment which fall under Radio Standards Specifications (RSSs) and Broadcasting Equipment Technical Standards (BETSs), respectively.

CANADA (ISED) – NEW REQUIREMENTS FOR WIRELESS DEVICE TESTING LABORATORIES

 Effective March 13, 2019

Notice was given that Innovation, Science and Economic Development Canada (ISED) would allow Certification Bodies to accept test reports from wireless test sites on file for testing completed prior to March 15, 2019, if uploaded to the Certification Engineering Bureau (CEB) system before June 15, 2019. This would allow an additional three (3) month grace period for projects that were already underway.

All testing performed after March 15, 2019 for new applications for certification should be performed by an ISED recognized wireless testing laboratory.

Within this three (3) month grace period, Certification Bodies should inform each manufacturer submitting a test report from a non-recognized Wireless Device Testing Laboratories that the reports from these laboratories would no longer be accepted after June 15, 2019.

CANADA (ISED) – CONSULTATION OF RSS-181, ISSUE 2

Proposed date of entry into force: To be determined

RSS-181, Issue 2, Coast and Ship Station Equipment Operating in the Maritime Service in the Frequency Range 1605-28000 kHz, sets out the certification requirements for equipment operating in the maritime service in the frequency range 1605-28000 kHz.

Colombia

POSTPONE EFFECTIVE DATE OF TECHNICAL REGULATION ON LABELING OF ZINC-CARBON AND ALKALINE BATTERIES

 Effective July 19, 2019

The Resolution № 0721 sets out requirements for the labeling of zinc-carbon and alkaline batteries as well as the requirements for the maximum permitted levels of heavy metals including new minimum information requirements.

This Regulation applies to all zinc-carbon and alkaline batteries, which are manufactured domestically or imported into Colombia except rechargeable batteries, button cell batteries, and batteries entered as non-commercial samples.

All batteries should comply with certain specific provisions regarding physical defects, dimensions, rated voltage, minimum average life expectancy, and designation. Batteries should undergo conformity evaluation and a certificate of conformity.

Cuba

CUBA (MICOM) – DRAFT TO SET UP HOMOLOGATION REQUIREMENTS

 Proposed date of entry into force: To be determined

Cuba issued a draft to set up homologation requirements in the country. This draft basically divides the products into two categories:

• Annex I: Products need to get the authorization letter from MICOM (Communications Ministry)
• Annex II: Products do not need the authorization letter from MICOM

Draft was published for comments and last day to receive comments is May 14^th 2019. After this date, it is assumed to take 6 to 12 months to entry into force.

Honduras

HONDURAS (CONATEL) – ELECTRICAL AND R&TT PRODUCTS

 Effective March 18, 2019

The National Telecommunications Commission (CONATEL) issued regulations and technical guidelines for the supply of telecom services and its fees, assures its compliance, and allocates permits and licenses.

Types of products that require CONATEL Approval:

• Radar
• Satellite
• Routers, Modems, and Gateways
• RFID and Bluetooth modules
• Cell phones etc.

The Homologation process is mandatory and applies to importers, manufacturers or sellers. Prior to import or sell, products covered by the Regulation must show the compliance through a Certificate of Homologation issued by the CONATEL.

The CONATEL accepts the certificates of conformity issued by:

• The Federal Communications Commission (FCC) of the USA
• The Federal Telecommunications Institute (IFT) of Mexico
• The European Economic Community (EC)
• The Telecom Engineering Center (TELEC in Japan)

Ecuador

Proposed date of entry into force: To be determined

The Republic of Ecuador has released the draft RTE INEN 009. In this new version of the RTE INEN 009, some test standards were updated, and new ones were added. Most standards are based on IEC and ISO standards.

Some of the proposed changes:

• CoC must be in Spanish or English
• User’s manual is a new requirement
• Surveillance is responsibility of MPCEIP (before MIPRO) and no longer INEN
• Certification schemes: 1a, 1b and 5.

India

INDIA (BIS) – CHANGES IN BIS REGISTRATION PROCESS – SMART REGISTRATION

Effective April 3, 2019

Bureau of Indian Standards (BIS) has modified their process for the registration of products under CRS.

The Smart Registration has been launched which will reduce the number of processes involved in registration. It allows manufacturers to track their registration request from the beginning of process including testing by using a smart app. This process will eliminate the requirement of submission of hard copies of test reports. The new process will require online generation of test requests, and confirmation from labs on proposed timelines before acceptance of samples by lab, and tracking of all this information by BIS.

BIS Smart Registration process timelines:

• April 3rd, 2019: Launch of smart registration
• April 4th, 2019: Login creation and registration of Labs on the new application
• April 10th, 2019: Labs to complete their registration
• April 16th, 2019: BIS to complete action of registration on labs
• May 20th, 2019: Labs not to accept the samples without test request generated form portal

Indonesia 

INDONESIA (SDPPI) – USAGE OF WIFI FREQUENCY BESIDE 2.4GHz and 5.8GHz

Effective March 15, 2019

SDPPI issued an announcement regarding the usage of Wifi frequency other than 2.4GHz and 5.8GHz. There are no available regulations for the usage of other frequency on WLAN except 2.4GHz and 5.8GHz.

SDPPI requested to mandate this to provide a letter of statement regarding the items below:

• Ready/Willing to Lock/Disable frequency band except 2.4 GHz and 5.8 GHz
• Ready/Willing to receive sanction if the product is found in the near future that is not complied with the applicable regulation

INDONESIA (SDPPI) – NEWS ON EMC

Effective March 31, 2019

SDPPI did not issue any further notification on extending the acceptance date of foreign EMC test report. Furthermore, there are currently only three local test laboratories that are capable to perform EMC test in Indonesia.

Mexico

MEXICO NEW VALIDATION SCHEME FOR SAFETY NOMs AT CUSTOMS

Effective June 3, 2019

The Mexican authority has released a new change regarding to the safety NOMs at customs. Goods cannot be imported without proving their compliance with safety NOMs at the point of entry into the country.

What are the bases of this new approval scheme?

Importer		CB		Customs-Standards System
You must go to the CB to certify your goods. Familiarize with the accredited CBs for each NOM.		Once the product is certified, the CB will upload the information to the Customs-Standards System		The CB must enter all required fields		The SE enables the importer by sending the information to SAT

What happens if I already have a valid NOM safety certificate?

You must go to their CB to provide the HS Code of the products to be certified, so that the HS Code is included in the certificate. The CB shall reprint said certificate and upload the information contained therein to the Customs-Standards System.

It’s important to take into account that as of June 3, 2019, any certificate that does not have the HS Code will not be validated in the Customs-Standards System; therefore, you will not be able to carry out your imports.

What happens if the certification of the product is in process?

Just as in the previous point, you must go to your CB to provide the HS Code of your products, so that they are contained in the issued certificate.

Once the certificate has been issued, the CB must upload the information contained therein to the Customs-Standards System to validate and carry out your operations.

Remember that as of June 3, 2019, you will not be able to import your goods subject to safety NOMs, without the validation of the corresponding certificate, which must include the HS Code of said goods.

Peru

PERU (MINISTRY OF MINING AND ENERGY) – ENFORCEMENT CERTIFICATE OF CONFORMITY (CoC) FOR ALL PRODUCTS LISTED IN RTEEE

Peruvian Government issued a Decree (DECRETO SUPREMO Nº 009-2019-EM) that established the new enforcement dates to present CoC for all products listed in the RTEEE – Technical Regulation for Energy Efficiency Labeling.

The new enforcement dates are:

• Lamps in general – November 3rd, 2019
• Motors – December 3rd, 2019
• Refrigerators – April 1st, 2020
• Washing Machines – April 1st, 2020
• Dryers – April 1st, 2020
• Air Conditioners – April 1st, 2020
• Water heaters – April 1st, 2020

Importers and distributors must incorporate the Energy Efficiency Label complying with the provisions of the Technical Regulations and its Annexes, without the need to present the Certificate of Conformity.

Philippines

PHILIPPINES (CDRRHR) – RULES AND REGULATIONS FOR IN-VITRO DIAGNOSTIC (IVD) MEDICAL DEVICE BASED ON ASEAN HARMONIZED TECHNICAL REQUIREMENTS

Proposed date of entry into force: This Order shall take effect 15 days after its publication in a national newspaper of general circulation.

The Department of Health through the Food and Drug Administration – Center for Device Regulation, Radiation Health and Research (CDRRHR) has adopted and implemented the AMDD guidelines on the registration of IVD medical devices and to provide the regulatory requirement and registration process.

ASEAN Agreement on Medical Device Directive (AMDD) in 2014, mandated the Philippines to implement the following provisions:

1. a) “require the person responsible for placing the IVD medical devices in that Member State or the authorized representative to register the IVD medical devices with the regulatory authority by of that Member State”
2. b) “shall undertake all necessary measures to ensure that only IVD medical devices which conform to the AMDD may be placed on markets of that Member State”
3. c) “put in place an appropriate system for the registration of IVD medical devices with the Regulatory Authority of that Member State”.

Saudi Arabia

SAUDI ARABIA (SASO) – ENERGY EFFICIENCY FUNCTIONALITY AND LABELLING REQUIREMENTS FOR LIGHTING PRODUCT, PART 3: STREET LIGHTING

 Proposed date of entry into force: 6 months after approval

This standard will set requirements for energy efficiency functionality and labelling for street and road lighting applications: Classification of street/road lighting, tunnel lighting and technical requirements of lighting products.

Thailand

THAILAND (NBTC) – UPDATING NBTC STANDARD FOR EMC (NBTC TS 001-2561), ELECTRICAL SAFETY (NBTC TS 4001-2561)

Effective March 15, 2019

NBTC released the following standards:

• NBTC TS 3001-2561 (Electromagnetic Compatibility) replaces NBTC TS 3001-2555

EMC requirements shall be complied with one of the following standards or other equivalent standards: TIS1956-2553, CISPR22:2008, and CISPR32:2015

• NBTC TS 4001-2561 (Electrical Safety) replaces NTC TS 4001-2550

Electrical safety requirements shall be complied with one of the following standards or other equivalent standards: TIS1561-2556, IEC60950-1, and IEC62368-1

Existing Type Approval Certificates issued based on the previous EMC and Safety standards remain valid.

THAILAND (TISI) – DRAFT THAI INDUSTRIAL STANDARD FOR AIR CONDITIONER: SAFETY REQUIREMENT (TIS 1529 – 25XX(20XX)

Proposed date of entry into force: To be determined

Thai Industrial Standards Institute (TISI) has proposed a new mandatory standard on air–conditioner: Safety Requirement (TIS 1529 – 25XX (20XX)).

This draft standard covers the safety requirement of air-conditioners incorporating motor-compressors:

• Maximum rated voltages not more than 250 V for single phase appliances
• Maximum rated voltages not more than 600 V for poly phase appliances
• Partial units
• Net total cooling capacity not more than 18 000 W
• Not intended for normal household use but which nevertheless may be a source of danger to the public, such as appliances intended to be used by laymen in shops, in light industry and on farms
• May consist of one or more factory made assemblies
• Containing flammable refrigerant

THAILAND (TISI) – DRAFT THAI INDUSTRIAL STANDARD FOR ROTATING ELECTRICAL MACHINES, PART 30-101 EFFICIENCY CLASSES OF AC, 3-PHASE INDUCTION MOTORS (TIS 866 Part 30(101) – 2561(2019))

Proposed date of entry into force: To be determined

The Thai Industrial Standards Institute (TISI) has proposed the draft compulsory Thai Industrial Standard for Rotating Electrical Machines Part 30-101 Efficiency Classes of AC 3-Phase Induction Motors (TIS 866 Part 30(101) -2561(2019)). The coverage of standard includes scopes; definitions and symbols; classifications; and efficiency classes of AC three phase induction motors for single speed electrical motors that are rated in accordance with TIS 866 Part 1 (Identical IEC 60034-1:2014), and rated for operation on sinusoidal voltage supply and:

• Have a rated power P_N from 0.12 kW to 375 kW
• Have a rated voltage U_N above 50 V up to 1 kV
• Have 2, 4, 6 or 8 poles

The energy efficiency classes are IE1, IE2, IE3 and IE4.

The testing method is in accordance with TIS 866 Part 2(1) (identical IEC 60034-1:2014).

Ukraine

UKRAINE RESOLUTION No. 264, ECO-DESIGN REQUIREMENTS FOR DIRECTIONAL LAMPS, LED LAMPS AND RELATED EQUIPMENT

Effective March 27, 2019

Cabinet of Ministers of Ukraine Resolution Draft “On approval of the Technical Regulation on eco-design requirements for directional lamps, light emitting diode lamps and related equipment” was adopted on March 27, 2019. It will enter into force on 4 October 2019.

United States

US (FCC) – SUPPLIER’S DECLARATION OF CONFORMITY (SDoC) PROCEDURES ARE NOW IN EFFECT

 Effective February 15, 2019

The Enforcement Bureau (EB) of the Federal Communications Commission (FCC or Commission) has issued this Advisory to remind any entity marketing radio frequency (RF) devices (marketers) that the devices may be subject to new compliance requirements provided in the Supplier’s Declaration of Conformity (SDoC) procedures. Devices subject to the SDoC procedures must be properly authorized, labeled, and furnished with the proper user information disclosures. Failure to comply may subject the violator to substantial monetary penalties that could total more than $150,000 per violation.

A device subject to SDoC is one that does not purposely transmit an RF signal for communications purposes. It does not send voice and/or data to a wireless receiver. This category includes a broad range of consumer and commercial devices such as computer peripherals, light-emitting diode (LED) signs, ultrasonic humidifiers, and microwave ovens. Most devices subject to SDoC are described in Sections 15.101 (a) and 18.203 of the Commission’s rules.

US (FCC) – GUIDE TO CERTIFICATION OF MODULAR TRANSMITTERS

Effective May 1, 2019

The Federal Communications Commission (FCC) has published guidelines for modular transmitter instruction manuals and the process of application reviews by a Telecommunication Certification Body (TCB).

This document provides guidance to grantees (applicants) seeking to certify a modular transmitter (module) and the key elements to be reviewed by a Telecommunication Certification Body (TCB) during the certification process. This guidance includes:

• The integration instructions to be provided by a grantee (applicant) to a host manufacture
• A list of key elements to be reviewed by a TCB during the certification process
• Guidance for grant comments to be included on the grant of certification

Details on FCC guidance can be found here

View Details on FCC guidance (United States)

Vietnam

VIETNAM (MIC) – REGULATIONS UPDATE

Effective July 1, 2019

Below are the new MIC regulations that will be mandated:

(1) QCVN 117:2018/BTTTT (equivalent to ETSI EN 301 908-13) RF requirements for  4G FDD LTE for all products, replaces QCVN 47:2015/BTTTT (applicable for 4G FDD LTE terminal devices / cell phone / tablet only)

(2) QCVN 118:2018/BTTTT (equivalent to CISPR 32:2015) for EMC requirements for Multimedia standards (include ITE and AV) , replaces TCVN 7189:2009 (CISPR 22:2006) and TCVN 7600:2010 (CISPR 13:2009)

(3) QCVN 66:2018/BTTTT replaces QCVN 66:2013/BTTTT as requirement for 3G W-CDMA FDD Repeater

(4) QCVN 16:2018/BTTTT replaces QCVN 16:2010/BTTTT as requirement for 3G W-CDMA FDD Base Station

(5) There will be new national standards issued by MIC Vietnam that will be updated soon

(6) MIC may release a new Circular to replace Circular 04/2018/TT-BTTTT and consolidate the list of devices under regulatory Type Approval Certification and Declaration of Conformity

(7) New version of QCVN 101:2016/BTTTT with below updates:

• Fixing some spelling and translation mistakes in QCVN 101:2016/BTTTT
• Test item “2.6.2.7 – Transportation” could be replaced by requirement on shock test and vibration test (local test reports or test report issued by MRA laboratories will be required)
• Test item “2.6.2.8 – “Force Internal Short Circuit” could be terminated
• With the new updates, the new QCVN 101:20xx will not be exactly equivalent to IEC 62133 and IEC 61960.

VIETNAM (MIC) – DRAFT NATIONAL TECHNICAL REGULATION BASED ON ETSI EN 301 489-52 V1.1.0 (2016-11)

Proposed date of entry into force: August 1, 2019

This draft National Technical Regulation specifies technical requirement on EMC for User Equipment (UEs) and ancillary equipment operated on mobile networks. This draft does not cover technical requirements related to antenna port and emissions from the enclosure port of radio equipment.

The National Technical Regulation is intended to supersede current National Technical Standards (QCVN 86:2015/BTTTT and QCVN 18:2014/BTTTT) for GSM, WCDMA, E-UTRA, LTE User Equipment and ancillary equipment.