借助 AI 驱动的注册文档编制和本地代理服务,加速市场准入,按固定年费收费。首个器械每年 2,000 美元起(不含政府费用)。包含文档提交、本地代理、翻译、变更、经销商授权及上市后支持。
Malaysia's MDA and China's NMPA have launched Pilot Phase 2 of the Malaysia-China Joint Evaluation Pilot Programme, open from 1 July to 30 September 2026. The programme enables simultaneous evaluation of eligible medical devices under the GHWP CERP framework to reduce duplicative review and support faster access to both markets.
From launching AI-driven regulatory solutions to expanding our global footprint, it was a year of meaningful milestones and shared moments.
探索我们的团队在领先媒体和行业平台上发表的文章和见解。
无论您是在寻找更多信息,还是已经准备与我们合作,我们都会在监管流程的每一步提供指导。