JNM Global

Global Approval Partner

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Hong kong MDD, Adds China and Korea to list of reference countries

The Hong Kong Medical Device Division (MDD) has announced that the “Essential Principles of Medical Device Safety and Performance” (Technical Reference: TR-004) will be available for use in the Medical Device Administrative Control System (MDACS) from 1 January 2024. Hong Kong's existing reference countries were Australia, Canada, the European Union, Japan, and the United States, but as the info..

Chile: SUBTEL announces amendment resolution on minimum technical specifications for TV receivers

On January 16, 2024, Chile's MTT published Resolution Nº 31, amending the existing Exempt Resolution Nº 7,219 of 2009 on minimum technical specifications for digital terrestrial TV receivers. The modifications introduced by the resolution will become effective from October 14, 2024. New updates to the existing resolution are as follows: 1. Introduction of definition of receiving antenna in Artic..

JNM Global 2024.02.20

MFDS, Notification of partial revision of medical device manufacturing and quality control standards_Expanding the scope of MDSAP review results

MDSAP is a certification system created by five regular member countries, the United States, Japan, Canada, Australia, and Brazil, for the purpose of joint review according to international standards for medical device safety and quality control. From December 19, 2023, the Ministry of Food and Drug Safety revised part of the Medical Device Manufacturing and Quality Control Standards to improve ..

Vietnam: MIC Update Technical Standards for Land Mobile Communication Terminal Devices

On December 29, 2023, MIC of Vietnam posted the circular 20/2023/TT-BTTTT. The circular approves new standard QCVN 117:2023/BTTTT for GSM, W-CDMA, UTRA Land Mobile User Equipment. The new main points of QCVN 117:2023/BTTTT are as follows: 1. VoLTE is mandatory 2. Additional LTE bands: 1) LTE B28: 703MHz – 733MHz / 758MHz – 788MHz 2) LTE B40: 2300MHz – 2400MHz 3) LTE B41: 2500MHz ~ 2690MHz The ci..

JNM Global 2024.02.06

Cosmetics production performance reporting guidance for 2023(~2024.2.29)

According to the law below, Responsible sellers are required to report the 2023 cosmetics production performance to the Korea Cosmetic Association from January 1, 2024 to February 29, 2024. • 「Cosmetics Act」 Article 5 / Article 4 (Duty of business operator, etc.) • 「Cosmetics Act Enforcement Rules」 Article 13 (Report on production performance of cosmetics, etc.) • 「Regulations on the production ..

JNM Global/Cosmetic 2024.02.02

< India – TEC Extension of Certification Deadline for 12 Products Under MTCTE Phase III and IV>

On December 27, 2023, TEC issued a notification partially amending no. 5-2/2021-TC/TEC/131 and 5-2/2021-TC/TEC/172. Accordingly, the mandatory certification date of 12 products out of 44 products under MTCTE Phase 3 and 4 has been postponed from January 1, 2024 to April 1, 2024. The mandatory date of the remaining 32 product shall remain unchanged. The postponed products are as follows: Phase Pr..

JNM Global 2024.01.30