JNM Global

Global Approval Partner

분류 전체보기 2493

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

Hong Kong MDACS, Published Software Medical Device and Cybersecurity Technical Reference Document (TR-007)

The Hong Kong Medical Device Administrative Control System (MDACS) has published a new technical reference document (TR-007) related to software medical devices (SaMD and SiMD) on December 29, 2023. Technical Reference TR-007 covers SiMD and SaMD risk management requirements and basic cybersecurity requirements. The software medical device technical documentation requirements for MDACS applicati..

Korea, Information on the 2023 customized cosmetics raw material list report(~2024.2.29)

What is customized cosmetics? This refers to cosmetics in which a person with a dispensing manager license divides the contents of cosmetics or mixes the contents of cosmetics with raw materials determined by the Minister of Food and Drug Safety. According to the law below, a list of all raw materials used in customized cosmetics must be reported to the Korea Cosmetics Association by the end of ..

JNM Global/Cosmetic 2024.01.23

韓国:MFDS医療機器民間審査機関の技術文書審査手数料引き上げ

MFDS2等級認証を受けるためには、技術文書審査機関の技術文書審査は必須です。 現在、2等級医療機器技術文書審査手数料は民間委託以後13年間審査手数料が凍結され、審査機関の経営悪化、苦情処理期間遅延、苦情サービス低下など悪循環がもたらされました。 手数料凍結による問題および他の業務の手数料引き上げ現況を反映して、2024.02.01から技術文書審査手数料が引き上げられます。 Category Current fee Increase fee Note New 1,400,000 2,464,000 Effective from 24.2.1 (10% VAT excluded) Change 1,100,000 1,936,000 Combination (New) 1,700,000 2,992,000 2024年2月から適用される第1段階の引き上げ手数料をご参考お願いします。 さら..