Global Market Access Regulatory Newsletter – Q4 2024

India Issues Memo on Self-Declared ETA Acceptance 

On Sept 9, 2024, the Ministry of Communications released a memorandum on "Issuance of Equipment Type Approval (ETA) for License-Exempt Wireless Equipment.” This is to help streamline doing business with telecom sector devices and grant permission to apply for self-declaration for equipment type approval (ETA) for wireless equipment devices. 

1. According to this memorandum, the competent authority has decided the following: 

• All the applications of equipment type approval (ETA) for wireless equipment devices, which have been license-exempt through various Gazette notifications issued, shall be granted to the applicant on a self-declaration basis. 
• Applicants are required to submit the applications on the Simplified Application For Registration and Licenses (SARAL) Sanchar portal (https://saralsanchar.gov.in/). 
• ETA holders must obtain a No Objection Certificate or other clearances (if applicable) from the Directorate General of Foreign Trade (DGFT) before importing the equipment. 

2. The main change between the new memorandum and the old memorandum of Feb. 26, 2019, is: 

• Expansion of ETA through self-declaration from certain categories based on the Office Memorandum of Feb. 26, 2019 to all the license-exempt wireless equipment. 
• Previously,  ETA on self-declaration was only permitted for equipment operating in delicensed bands and exempt from import licensing requirements under the import/export policy. For the rest of the products, self-declaration was not allowed. Now, self-declaration is permitted for all other products as well. 

WPC & SACFA

Issuance of Equipment Type Approval (ETA) for License-Exempt Wireless Equipment Devices

European Union Harmonizes Energy Efficiency Standards  

The European Commission published lists of harmonized standards for Ecodesign and Energy Labelling of Air Heating and Cooling Products and of Commercial and Professional Refrigerating Appliances.

Standards published in the Official Journal (OJ) as harmonized standards, help manufacturers demonstrate that their products comply with European regulations and directives.

New lists have been published in the field of energy efficiency for these regulations and products:

The involved standards are: 

• EN 1397:2021 Heat exchangers – Hydronic room fan coil units – Test procedures for establishing the performance 
• EN ISO 23953-2:2023 Refrigerated display cabinets – Part 2: Classification, requirements and test conditions 
• EN 13215:2016+A1:2020 – Condensing units for refrigeration – Rating conditions, tolerances and presentation of manufacturer’s performance data 

These are all first publications and manufacturers can start using them now. When demonstrating product compliance, the standards are included in the EU Declaration of Conformity. 

Commission Implementing Decision (EU) 2024/1589 of 4 June 2024 on the harmonised standards for condensing units for refrigeration drafted in support of Commission Regulation (EU) 2015/1095

Commission Implementing Decision (EU) 2024/2397 of 11 September 2024 on a harmonised standard for refrigerating appliances with a direct sales function drafted in support of Delegated Regulation (EU) 2019/2018 and Regulation (EU) 2019/2024

Commission Implementing Decision (EU) 2024/2638 of 9 October 2024 on the harmonised standards drafted in support of Regulation (EU) 2016/2281 laying down ecodesign requirements for air heating products, cooling products, high temperature process chillers and fan coil units

Directive 2009/125/EC and Regulation (EU) 2017/1369

South Korea – Energy Efficiency Regulation Updates 

On Oct. 29, 2024, the South Korean Ministry of Trade, Industry and Energy (MOTIE) published a revision of Regulations on the Operation of Efficiency Management Equipment through MOTIE No. 2024-169.

The purpose of this revision is to adhere to energy-saving measures by strengthening item-specific standards for the improvement of the domestic equipment management system. This revision also adds new items and transfers standby power reduction target items to efficiency rating system target items.

The revision includes:

Introduction of new items of efficiency management equipment

• Garment care machine – Increase market penetration and introduce a clothing management machine with high electricity consumption as an efficiency management equipment item

Reinforcement of efficiency standards for existing items

• Electric rice cooker – Improve the measurement standards reflecting the actual user environment, reinforce consumption efficiency rating criteria and minimum consumption efficiency standards

• Electric fan heater – Change the labeling items (power consumption to heating efficiency) and strengthen the minimum consumption efficiency standards

Transfer of the system to strengthen the efficiency standard

• Electric range – Conversion of Efficiency Management System (Minimum Consumption Efficiency Standard System to Efficiency Rating System) 

• Bidet – Transfer from standby power reduction program items to efficiency management equipment 

Notes: 

The system transfer for bidets was first published in this draft article: News ID 6811 

Supplementary provisions 

1. The effective date for the amendments to electric rice cookers, electric ranges and electric fan heaters is July 1, 2025. The revised regulations shall apply to these products that are manufactured on or after July 1, 2025. 
2. The effective date for the amendments on garment care equipment and bidets is Jan. 1, 2026. The revised regulations shall apply to these products that are manufactured on or after Jan. 1, 2026. 

Notes: In the case of Paragraphs 1 and 2, the date of manufacture shall be based on products manufactured and imported from abroad. 

https://www.law.go.kr/

https://eep.energy.or.kr/

https://eep.energy.or.kr/common/fnc/file_download

EU Adopts Cyber Resilience Act 

On Oct. 10, 2024, the EU Council adopted the "Regulation of the European Parliament and of the Council on Horizontal Cybersecurity Requirements for Products with Digital Elements and Amending Regulations (EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828". Also titled the Cyber Resilience Act (CRA), it provides cybersecurity requirements for products with digital elements to ensure that products, such as connected home cameras, fridges, TVs and toys, are safe before they are placed on the market. 

When placing a product with digital elements on the market, manufacturers shall demonstrate that it has been designed, developed and produced in accordance with the essential cybersecurity requirements. Security aspects must be taken into account during a product's development processes and throughout its whole life cycle, as outlined by Part I and Part II of Annex I of this Regulation. As of now, there is no harmonized standard yet. 

Some of key provisions are as follows: 

1. Manufacturers shall undertake an assessment of the cybersecurity risks associated with a product with digital elements and take the outcome of that assessment into account during the planning, design, development, production, delivery and maintenance phases of the product with digital elements. 
2. Manufacturers shall, upon identifying a vulnerability in a component integrated into the product with digital elements, report the vulnerability. 
3. Manufacturers shall systematically document relevant cybersecurity aspects concerning products with digital elements. 
4. Manufacturers shall ensure that their products with digital elements bear a type, batch, serial number or other element allowing their identification. They should also indicate their details such as the name, registered trade name or registered trademark and the postal address, email address or other digital contact details of the manufacturer. 
5. Manufacturers shall either provide a copy of the EU declaration of conformity or a simplified EU declaration of conformity with the product with digital elements. Software and hardware products will bear the CE marking to indicate that they comply with the requirements of this Regulation. 
6. Noncompliance with the essential cybersecurity requirements and the obligations set out shall be subject to administrative fines of up to EUR 15,000,000 or, if the offender is an undertaking, up to 2.5% of its total worldwide annual turnover for the preceding financial year, whichever is higher. 

This regulation provides 36 months of transition period. Products placed on the market before the transition period ends do not have to comply with the CRA. However, if there is any substantial modification made to the product after the transition period ends, the product must comply with the CRA. Please also note that the reporting obligation set out by Article 14 still applies to products placed on the market even before the transition period ends. 

Following this adoption, the legislative act will be signed by the presidents of the Council and of the European Parliament and published in the EU’s official journal in the coming weeks. 

Cyber resilience act: Council adopts new law on security requirements for digital product

Taiwan BSMI Publishes Latest Certification Information Booklet  

On Aug. 26, 2024, the Bureau of Standards, Metrology and Inspection (BSMI) of Taiwan released the latest version 1.85 of the Taiwan Commodity Inspection Schemes for Electrical and Electronic Products (Conformity Assessment) Information Booklet. This version will integrate the changed requirements for regulated products for BSMI certification in the past and replace the old 1.84 booklet version.

These updates include the following changes:

• Updated “Regulated Electrical Equipment and their Applicable Standards” table with the latest inspection requirements and C.C.C. Codes. (Appendix C-1, page 33-63).
  • For freezers, since BSMI decided to expand the scope of legal inspection to include both upright and horizontal freezers with a storage volume not exceeding 700 liters, the product description and name are also changed in the new booklet.
• Changed "Upright freezers" to "Freezers".
• Extended the rated storage volume from "not exceeding 400L" to "not exceeding 700L" with an implementation date of Jan. 1, 2025.
• Added information to reflect BSMI including portable air conditioners into the mandatory scope with an implementation date of Jan. 1, 2025.
• Updated “Regulated Electronic Equipment and their Applicable Standards” table with the latest inspection requirements and C.C.C. Codes. (Appendix C-2, page 64-84).

For the applicable standards valid until Dec. 31, 2023, the authority removed this information in the new booklet. After updates, the regulated list in Appendix C-2 of the new booklet is based on the currently applicable standards. The following standards are no longer valid for some regulated products.

• CNS 13438 (2006)
• CNS 14336-1 (2010)
• CNS 14408 (2004)
• CNS 60335-2-29 (2016)
• CNS 15425-1 (2015)
• CNS 13439 (2004)
• Technical Specification for Digital Terrestrial Television Receivers (2011)

Therefore, 53 regulated product categories related to chargers and AV/IT products have updated applicable standards, and invalid standards have been removed. 

Conformity Assessment Bodies

Schemes for electrical and electronic products

Mexico Announces Digital Transformation and Telecommunications Agency

On Nov. 12, 2024, the Chamber of Deputies of Mexico announced a ruling that proposed changes to the federal public administration.

This includes the establishment of the Digital Transformation and Telecommunications Agency. Its objective is to unify technological capabilities, simplify government procedures, generate savings and reduce opportunities for corruption in federal agencies.

The agency will be headed by José Antonio Peña Merino, and the work will focus on seven points:

• Making procedures that exist in person available digitally.
• Minimizing the regulatory burden for people and companies.
• Generating savings and opportunities to have zero corruption.
• Creating the Well-Being Assistance Center (CABI), through the number 079, which provides citizen assistance 24 hours a day.
• Implementing intelligence and data analysis to strengthen public capacities.
• Technological autonomy and information security.
• Internet as a right.

The Digital Transformation and Telecommunications Agency plans to start its operations on Jan. 1, 2025.

The Federal Institute of Telecommunications (IFT) has not yet disappeared. Ricardo Monreal, the coordinator of the Chamber of Deputies, has maintained that various powers of the IFT will exist within the Digital Transformation and Telecommunications Agency, while President of Mexico Claudia Sheinbaum has said that they will be located in the decentralized part of the Ministry of Economy.

Further updates shall be published accordingly. 

Dan en Cámara de Diputados trámite de publicidad a dictamen que propone cambios en la Administración Pública Federal