On September 12, 2023, BEE made an announcement regarding refrigerators (both Frost Free and Direct Cool) registered under their Standards and Labelling program. BEE has temporarily suspended the requirement for manufacturers and permittees to use QR codes on their appliances until further notice. For this, Permit holders are required to provide serial numbers of appliances to BEE. This directiv..

TRC of Jordan has recently revised the existing and outdated SRD regulation for Jordan, and they have now published the updated Type Approval Regulation Version #2. Here is a scope of the adding bands and removing bands in the new SRD Regulation: Adding Band Applicable products 26957-27283 KHz Inductive devices 27090-27100 KHz Inductive devices 174-216 MHz Radio Microphones 470-694 MHz Radio Mic..

The Medical Device Control Division of the Thailand Food and Drug Administration (Thai FDA) has recognized the Singapore Health Sciences Authority (HSA) as a reference regulatory agency. The Thai FDA and Singapore HSA have agreed to collaborate to expedite the registration process of medical devices through a Regulatory Reliance Program. Participation is possible if you are a medical device regi..

China's National Medicines Agency (NMPA) has announced amendments to its catalog to classify medical devices. Manufacturers need a lot of attention because the amendment affects the cost and time of medical device registration. The 56 changes announced include adding new products, changing descriptions of some devices, and changing some device classifications. We inform you of the major revision..

Indonesia is the third country to implement the AMDD standard, following Singapore and Malaysia. Indonesia is classified into Class A, Class B, Class C, and Class D according to risk, and product groups are broadly classified into five categories. · Radiation electromedical devices · Non-radiation electromedical devices · Sterile non-electromedical devices · Non-sterile non-electromedical device..

The European Medical Device Regulations (Regulation 2017/745, MDR) require that each particular device model has its own UDI-DI. Contact lenses vary widely, requiring the manufacturer to specify a number of UDI-DI. The EC adopted this mandate out of concern that a higher number of UDI-DI would lead to a surge in medical device registrations in EUDAMED. The amendment takes effect on November 9, 2..

BOCRA is mandated by the Communications Regulatory Authority Act to manage type approve of telecommunications equipment that may be connected, used, or operated to provide Communications Services in Botswana. Type Approval regime is meant to ensure that communications equipment’s used in Botswana are compliant with national standards, which cover Health and Safety, Electro-magnetic Compatibility..

From February 28 of 2024, ISI certificate is required for Plywood and Wooden flush door shutters according to the relevant Quality Control Order. The scope of the order and applicable standards are as follows: Goods and Articles Indian Standard Title of Indian Standard Plywood and Wooden flush door shutters 303:1989 Plywood for general purposes 2202 (Part 1):1999 Wooden flush door shutters (soli..

CBTL Guoce Testing Technology (Suzhou) Co., Ltd. CBTL Guoce Testing Technology (Suzhou) Co., Ltd. has been accepted to operate in the IECEE CB Scheme, under the responsibility of NCB SGS Testing & Control Services Singapore Pte Ltd. New standards in IECEE System on 24/10/2023 The following standards have been added to the CB Scheme: MED IEC 60601-2-75:2017/AMD1:2023 New standards in IECEE System..

メキシコの医療機器および体外診断医療機器は、メキシコ標準NOM-241-SSA1-2021に従います。 メキシコは危険に応じてClass I、Class II、Class IIIに分類され、すべての医療機器および体外診断医療機器は衛生登録が義務付けられています。 メキシコの医療機器および体外診断医療機器に関する規制当局は次のとおりです。 - 医療機器の評価、管理及び監視を担当する保健省（Ministry of Health） - 医療機器の輸出及び流通のための必須製品を認証する場所であるコペフリース(Cofepris) - 国民の疾病、負傷に対する予防、診断、治療等に対する保険を担当する社会保障保険庁IMSS (Instituto Mexicano del SeguroSocial) 医療機器および体外診断医療機器は、使用目的に応じて医療機器、人工物または補助器、診断団体の3種類に分類..