Mediven’s Regulatory Strategy Shift
Faster ASEAN Market Entry for China Manufacturers – Now Supercharged with Malaysia’s Global Regulatory Reliance Leadership
助力中国制造商更快进入东盟市场 —— 马来西亚引领全球注册互认加速通道！
Medical Device Contract Manufacturing & Regulatory Solutions
Medical Device Contract Manufacturing & Regulatory Solutions is a business unit established to support partners with production, regulatory submissions, and market access, while our core business continues to focus on the manufacturing and distribution of our own portfolio of high-quality medical devices.
医疗器械合同制造与法规解决方案是一个业务部门，旨在支持合作伙伴完成生产、法规申报和市场准入工作，同时我们的核心业务仍专注于自主高质量医疗器械产品的生产和分销
Mediven offers a faster, smarter pathway
Mediven 提供更快捷、更高
Early entry into ASEAN
(Malaysia, Singapore, Indonesia)
快速进入东盟市场
（马来西亚、新加坡、印尼）
Registration in <1 year
(vs. 2–3 years for NMPA)
注册周期少于1年
（相比NMPA的2–3年）
Generate sales while NMPA/CE
is pending
在等待NMPA/CE认证期间
即可开始销售
We act as your
Authorized Representative
我们可担任您的“授权代表”
（Authorized Representative）
Adapt existing China or CE dossiers
into ASEAN CSDT format
协助将您现有的中国或CE注册资料
转换为东盟CSDT格式
NEWS 重磅消息: Malaysia Leads the World in Regulatory Reliance 马来西亚全球领先的注册互认机制
As announced by the Malaysian Medical Device Authority (MDA), Malaysia is now globally recognized for its Regulatory Reliance Programme.
马来西亚医疗器械管理局（MDA）宣布，马来西亚现已成为全球注册互认机制（Regulatory Reliance Programme）的领跑者。
1.What does this mean for China manufacturers? 这对中国制造商意味着什么？
Under Regulatory Reliance 在注册互认政策下:
• Products registered or approved in countries like China, Australia, Canada, EU, Japan, UK, and the U.S. may qualify for an accelerated registration in Malaysia. 已在中国、澳大利亚、加拿大、欧盟、日本、英国和美国等国家获批的产品，可加速在马来西亚注册。
• China NMPA-approved products can benefit from streamlined review, fewer local testing requirements, and faster approval. 获NMPA认证的产品将享受更快速的审查流程、减少本地测试要求，加快获批时间。
2.Why This Matters 关键节点
• Launch faster in Malaysia and ASEAN—without waiting for CE or full global approvals. 无需等待CE或全球认证，即可快速进入马来西亚及东盟市场。
• Use your existing NMPA or CE documentation. 可沿用您现有的NMPA或CE注册文件。
• Build early revenue streams. 快速建立销售渠道，提前布局市场。
• Position your product in Southeast Asia’s growing healthcare market. 锁定东南亚医疗市场高速增长红利。
