REGULATORY NEWS

Hong Kong Amends Requirements for Toys and Children Products

The Government of Hong Kong issued an updated list of standards for toys and children products. According to the Decree (cap 424) manufacturers of the following classes of products must meet the relevant requirements of the applicable safety standards to put the product on the market: babies’ dummies baby walking frames child safety barriers for domestic use children’s cots for domestic use children’s high chairs and multi-purpose high chairs for domestic use children’s paints playpens for domestic use wheeled child conveyances The list will become effective from October 2020 and contain the following standards: The information has been prepared by the GMA Consult Group team. GMA Consult G

European Union Approves New List of Harmonized Standards for Medical Devices

New lists of harmonized standards was published in the Official Journal of the EU on March 25, 2020. The lists relate to the three Directives on medical devices: Council Directive 93/42/EEC of June 14, 1993 concerning medical devices Council Directive 90/385/EEC of June 20, 1990 on the approximation of the laws of the Member States relating to active implantable medical devices Directive 98/79/EC of the European Parliament and of the Council of October 27, 1998 on in vitro diagnostic medical devices It was developed based on the above-mentioned documents. The harmonized standards aim to protect the health of the general public and workers and to prevent risks associated with the design, manu

China Implements Technical Requirements for Donated Textiles

In China, a new category of standard for donated textiles appeared. The new standard GB/T 38418-2019 “General Technical Requirements for Donated Textiles” specifies terms and definitions of donated textiles, product classification, technical requirements, test method, inspection rules, packaging, storage, and marking. This standard applies to unused and used donated textile products that are received through public welfare or other institutions and can be reused after professional disinfection treatment and maintenance. However, donated infant textile products are out of scope of the standard. Thus, it specifies two categories of product: Category I - unused textile products, including also

Canada Issues New Regulation on Batteries

ONTARIO REGULATION 30/20 on Batteries under the Resource Recovery and Circular Economy Act, 2016 was published in The Ontario Gazette on March 14, 2020. This Regulation applies to primary and rechargeable batteries with a weight of 5 kg or less. The document establishes requirements to the way of collection of batteries and obliges every manufacturer to establish and operate a system for managing batteries by determining and satisfying their management requirement with respect to each applicable category of batteries. From now, every company that produces and put batteries on the market of Ontario as well as producer responsibility organizations, battery haulers, battery processors, and batt

Opening up a New Market for Tablets in South Korea

Entering a new market is a real challenge especially for manufacturers of telecom products whose industry is specific and highly competitive. Moreover, many accessories and components of such equipment may have special terms within the market access procedure. Learn how GMA Consult Group helped a UK manufacturer open up new boundaries for their tablets in South Korea. Download case study The information has been prepared by the GMA Consult Group team. GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations,

Saudi Arabia Extends Validity of Certificates

The Saudi Standards, Metrology, and Quality Organization announced that it will extend certificates of conformity if they were registered on the Saber platform and their validity period ends in March, April or May 2020. Such certificates will be valid for three months from the expiration date. SASO also mentioned that test reports issued by the accredited lab in the exporting country in the past 3 years can be accepted as well. Thus, for products that have such test reports, new testing is not required. These actions were implemented as an exceptional initiative for rapid entry of products in the Saudi market that allows traders and importers to issue a consignment certificate from the "Sabe

South Korea Launches Compulsory Quality Evaluation System for Packaging

The Government of South Korea keeps paying attention to the process of saving and recycling of resources. Recently, it launched the evaluation system to control the quality and structure of packaging materials. According to this system, manufacturers of recyclable packaging must estimate the recycling level for their products and check whether the used materials comply with the essential national standards. Once the manufacturer does it, he must provide the results together with the relevant documents to the Korean Environmental Corporation. Therefore, the Corporation checks the provided documents to make sure that the results are accurate and complete. Based on the evaluation results receiv

Russia Сhanges Procedure for FSS Notifications Submissions

Due to the coronavirus epidemic and preventative measures taken in Russia, Federal Security Service (FSS) introduced limitations on personal submission and issuance of original documents. Until the end of April, documents can be submitted only by postal services. If the results of analysis are positive and FSS notification is registered, the original registered FSS notification will not be issued to the applicant until the end of the month. According to preliminary information, issuance of original documents will be decided by FSS after April 30. As the information on every registered FSS notification is entered into the Unified register, for the import of controlled products into the terri

Quick Guide to the Main Ruling Documents for Medical Devices in the EU

All medical devices to be placed on the EU market must have a CE mark. Thus, a medical device must meet requirements of the EU ruling documents. The Directives 90/385/EEC and 93/42/EEC were used previously. However, EU MDR was established in 2017 and preliminary should be adopted by May 26, 2020. If certificates were issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC up to 2020, they remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void not later than May 27, 2024. The EU MDR contains significant changes in approach to the medical device approval. These changes h

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