マラウイのMACRAは今年初めにラベル制度を導入すると発表しています。 MACRAは今回、ラベル草案を新たに発表し、マラウイ規定 "Communications (Type approval) Regulation 2023”の"Terms and Conditions of a Type Approval Grant" 項目は2024年12月1日から施行される予定です。    MACRAはラベル草案に対する意見を11月15日までに取りまとめます。   新たに発表されたラベルの草案には、次のような事項が含まれている必要があります。 1. MACRA機関ロゴ  2. モデル名  3. アルファベットと数字からなる承認書ID:MLW/MACRA/TA/YYYYY/XXXX(MALAWI/MACRA/TYPE APPROAL/TYPE APPROVED YEAR/Type Approval ..

CITRAの昨年発表された決議案No.297/2023により、2G、3Gのみ支援する通信機器のクウェートへの輸入権限が停止すると、先日ご案内したことがあります。  クウェートのCITRAは2024年9月1日、決議案No.278/2024を追加で発表しました。 この決議案に基づき、クウェートでは3Gネットワークサービスが2025年6月1日まで中断される予定です。 Q&A info@jnmjapan.net

As of October 11, 2024, the Ministry of Food and Drug Safety has registered the revised version of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials). The revised contents of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials) are briefly as follows. 1. R..

On October, 24, 2024, the Office for Product Safety and Standards (OPSS) requested all stakeholders, including the cosmetics industry, academia, consumer associations, and others, to submit scientific information related to the safety assessment of the following cosmetic ingredients:1.     Prostaglandins and prostaglandin analogues2.     Alpha and beta-arbutin3.     Vitamin A All scientific data..

PMDA (Pharmaceutical and Medical Device Agency) is a comprehensive pharmaceutical and medical device organization that aims to contribute to improving national health by guiding and examining the quality, efficacy, and safety of pharmaceuticals and medical devices, and collecting, analyzing, and providing information on safety after marketing. Japan's medical device classification system is base..

On October 7, 2024, the Thailand Food and Drug Administration (TFDA) announced new guidelines regarding labeling requirements for In Vitro Diagnostic Medical Devices (IVD). These guidelines clarify labeling methods for both home-use and professional-use IVDs, with key points outlined below.  1.   Labeling Requirements for Home-Use- Labels must be affixed in clearly readable Thai and English (pro..

According to the announcement made by the UK OPSS on October 14, 2024, all cosmetics containing the banned ingredient “Lilial” must be discarded, and the recall of products sold after the ban is being considered.  Lilial(Butylphenyl methylpropional), a fragrance ingredient that provides a lily scent, has been used in shampoos, perfumes, and body products, etc. However, it is known to raise safet..

Health Canada (HC) published amendments to certain regulations concerning the disclosure of cosmetic ingredients (SOR/2024-63) on April 24, 2024, which came into effect on October 9.  This includes adjustments to regulatory requirements that may impact all stakeholders in the cosmetic industry, making it essential to review the updated regulations.  The amended regulations strengthen labeling re..

The Ministry of Health (MoH) of Republic of Indonesia issued circular no. HK.02.02/E/1753/2024 on September 9, 2024, to implement the Good Distribution Practice (GDP) certification as a requirement for the electronic catalog system, ensuring the safety, quality, and performance of medical devices.According to Government Regulation No. 28 of 2024 (implementing Law No. 17 of 2023 on Health), the k..

On October 8, 2024, the European Commission’s Medical Device Coordination Group (MDCG) announced guidance MDCG 2024-11 regarding the qualification of in vitro diagnostic medical devices (IVDs). To achieve qualification as an IVD or an accessory, a product must meet the criteria defined in Article 2(2) or Article 2(4) of the IVDR. The MDCG 2024-11 guidance clarifies the scope of products covered ..