With the implementation of the Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase 1), China's National Medical Products Administration (NMPA) and Malaysia's Medical Device Authority (MDA) have made significant achievements in international cooperation and mutual trust. The MDA has established a "regulatory mutual trust fast track" for Chinese medical device enterprises, a breakthrough policy that will accelerate the entry of Chinese enterprises into the Malaysian market. From November 10 to 13, 2025, the China Medical Device Industry Association (CAMDI) successfully held the "China-Malaysia Medical Device Industry Exchange Conference" and a series of inspection activities in Kuala Lumpur, Malaysia. This event, through face-to-face exchanges with Malaysian officials, business environment observations, and hospital inspections, provided Chinese enterprises with an authoritative opportunity and efficient channel to conduct precise economic and trade negotiations, understand the latest local regulations, policies, and market conditions, enhance CAMDI member units' international brand influence, and promote Chinese enterprises' overseas expansion.
Activity One: Visit to the MDA of Malaysia
The China-Malaysia industry exchange activity successfully kicked off in Kuala Lumpur, where the delegation was honored to be received by the MDA of Malaysia. CEO Dr. Muralitharan warmly welcomed all members of the delegation and, together with heads of various Malaysian departments, held discussions to introduce in detail Malaysia's medical device regulatory policies, particularly the policy for the accelerated approval of medical device marketing. Through a full day of exchanges, the delegation gained a comprehensive understanding of Malaysia's policies and market conditions, and several key concerns received authoritative responses. This exchange activity marked the first high-level reception of a Chinese industry delegation by the Malaysian regulator, highlighting the solid mutual trust and strong intention for cooperation between the medical device industries of the two countries.
In her remarks, Yang Xiaofang, Deputy Secretary General of CAMDI, stated that with the high-quality development of China's medical device industry and the further opening of Malaysia's industrial policies, bilateral cooperation in the medical device field is welcoming the dual benefits of a favorable policy environment and industrial environment. This visit aims to provide Chinese enterprises with authoritative insights from multiple dimensions, including rapid product registration and marketing, medical insurance support, and preferential investment policies, through face-to-face promotional exchanges with the highest regulatory officials and on-site inspections, while establishing direct dialogue platforms with key Malaysian partners to jointly promote the healthy development and mutual benefit of medical device industries in both countries.
Activity Two: Thematic Exchange
The delegation held discussions with Malaysian industry experts on policies and industry conditions. Ms. Tran Quan, member of the GHWP Strategic Advisory Board, Dr. Sasikala Devi Thangavelu, former Director of the MDA of Ministry of Health, Malaysia, and officials from the Ministry of Science, Technology and Innovation (MOSTI) conducted explanations and discussions on core regulations, including the Malaysian medical device registration framework, the Malaysia–China Medical Device Regulatory Reliance Programme, ASEAN Medical Device Directive (AMDD), and product CAB certification and assessment.
In her remarks, Ms. Tran Quan, member of the GHWP Strategic Advisory Board, stated that both as GHWP members, China and Malaysia uphold the principles of convergence, harmonization, and trust, promoting the interconnection of regulatory practices and the industry. This activity, based on the cooperation framework between the regulatory authorities of the two countries, will bring tangible progress for the win-win development of the medical device industries in both nations. She thanked CAMDI, as the sole industry association representing the sector in China, for its efforts in regulatory coordination and industry exchanges, and expressed expectation for Chinese enterprises to achieve greater development in Malaysia.
Activity Three: Visit to Malaysian Investment Development Authority and Hospital Inspection and Exchange
The delegation subsequently visited the Malaysian Investment Development Authority and held discussions with its officials to gain a detailed understanding of Malaysia's development data and the processes and policies for medical device investment access. The delegation also visited distinctive Malaysian private and public hospitals and held discussions with hospital CEOs and department heads to understand in detail the processes and policies for Chinese medical devices to be included in hospital procurement.
This series of activities in Malaysia featured substantial content and precise matchmaking, in which the Chinese medical device industry received the highest-level reception from Malaysian regulators for the first time. It set up a face-to-face communication platform for Chinese medical device enterprises to comprehensively understand Malaysian regulatory policies and market environment and connect with core resources, and offered an excellent opportunity for the Chinese medical device industry to accelerate deployment in Malaysia and ASEAN markets and achieve mutual benefit and win-win results. Participating enterprises expressed sincere gratitude for this rewarding event and for the meticulous organization by CAMDI and the high-level reception from Malaysia.
Activity One: Visit to the MDA of Malaysia
The China-Malaysia industry exchange activity successfully kicked off in Kuala Lumpur, where the delegation was honored to be received by the MDA of Malaysia. CEO Dr. Muralitharan warmly welcomed all members of the delegation and, together with heads of various Malaysian departments, held discussions to introduce in detail Malaysia's medical device regulatory policies, particularly the policy for the accelerated approval of medical device marketing. Through a full day of exchanges, the delegation gained a comprehensive understanding of Malaysia's policies and market conditions, and several key concerns received authoritative responses. This exchange activity marked the first high-level reception of a Chinese industry delegation by the Malaysian regulator, highlighting the solid mutual trust and strong intention for cooperation between the medical device industries of the two countries.
[MDA CEO Dr. Muralithara]
In her remarks, Yang Xiaofang, Deputy Secretary General of CAMDI, stated that with the high-quality development of China's medical device industry and the further opening of Malaysia's industrial policies, bilateral cooperation in the medical device field is welcoming the dual benefits of a favorable policy environment and industrial environment. This visit aims to provide Chinese enterprises with authoritative insights from multiple dimensions, including rapid product registration and marketing, medical insurance support, and preferential investment policies, through face-to-face promotional exchanges with the highest regulatory officials and on-site inspections, while establishing direct dialogue platforms with key Malaysian partners to jointly promote the healthy development and mutual benefit of medical device industries in both countries.
[Yang Xiaofang, Deputy Secretary General of CAMDI]
The delegation held discussions with Malaysian industry experts on policies and industry conditions. Ms. Tran Quan, member of the GHWP Strategic Advisory Board, Dr. Sasikala Devi Thangavelu, former Director of the MDA of Ministry of Health, Malaysia, and officials from the Ministry of Science, Technology and Innovation (MOSTI) conducted explanations and discussions on core regulations, including the Malaysian medical device registration framework, the Malaysia–China Medical Device Regulatory Reliance Programme, ASEAN Medical Device Directive (AMDD), and product CAB certification and assessment.
[Ms. Tran Quan, Member of the GHWP Strategic Advisory Board]
[Dr. Sasikala Devi Thangavelu, former Director of the MDA of Ministry of Health, Malaysia]
Activity Three: Visit to Malaysian Investment Development Authority and Hospital Inspection and Exchange
The delegation subsequently visited the Malaysian Investment Development Authority and held discussions with its officials to gain a detailed understanding of Malaysia's development data and the processes and policies for medical device investment access. The delegation also visited distinctive Malaysian private and public hospitals and held discussions with hospital CEOs and department heads to understand in detail the processes and policies for Chinese medical devices to be included in hospital procurement.