Quick Asia Regulatory Updates (June 2026)

Singapore’s Health Sciences Authority (HSA) and China’s National Medical Products Administration (NMPA) have renewed their regulatory cooperation agreement for health products, signing an updated Memorandum of Understanding (MOU) in Beijing on May 11, 2026. The revised agreement expands cooperation into newer areas, including cell, tissue, and gene therapy products. Both agencies also said they plan to work more closely on regulatory pathways, pilot initiatives, staff exchanges, and the sharing of regulatory information and experience. The renewed partnership builds on an earlier agreement signed in 2021 and is expected to support more efficient review and market access processes for innovative therapies and medical technologies in both countries. Officials from both agencies said the collaboration is intended to strengthen regulatory capabilities while continuing to maintain product safety, quality, and efficacy standards.

Malaysia’s Medical Device Authority (MDA) published new guidance in April on the importation and supply of unregistered medical devices via the Special Access Exemption (SAE) scheme. This updated guidance contains more information about the application process, eligibility criteria, necessary documents required for submission, and obligations after approval. SAE refers to the use of unregistered medical devices in exceptional circumstances where there is no registered alternative product available. An SAE application needs to be submitted via the MeDC@St platform, and approval of this application should be acquired prior to the importation and supply of these unregistered devices in Malaysia. The applicant will also need to ensure sufficient record-keeping, proper device utilization, and compliance with any other conditions imposed by the MDA.