Health Canada is implementing ICH Q12 in a phased manner, with an initial, targeted change for stakeholders: within BRDD, industry will be able to submit Post Approval Change Management Protocols (PACMPs) as a new, more predictable mechanism to manage post-approval changes, beginning August 13, 2026, supported by updated guidance. This first phase does not include broader Q12 elements such as Established Conditions (ECs), and does not yet apply to PDD-regulated products; additional expansions will follow. Overall, this represents a shift toward more structured, lifecycle-based regulatory oversight aligned with international standards, while maintaining a controlled and gradual implementation approach.

​

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in May 2026. These updates are presented by China Med Device, LLC, your partner in Chinese market access. Policies As China Overhauls GMP, KARL STORZ’s High-frequency Surgery System Faces Import Suspension Over QMS Failures The NMPA issued a remote […]

The post NMPA Roundup May 2026 appeared first on China Med Device.

​

NMPA published the “2026 Medical Device Guidelines Revisions Plan” on April 27, 2026, affecting 56 Class III and 219 Class II devices. The revisions are aimed to facilitate manufacturers with clarity in type testing, non-clinical and clinical evaluation and regulatory submission. Significance of NMPA Guidelines The guidelines are introduced by NMPA Center of Medical Device […]

The post NMPA: 56 Class III Devices impacted by 2026 Guidelines Revisions Plan appeared first on China Med Device.

​

WE, the Member States of the Association of Southeast Asian Nations (ASEAN) -namely Brunei Darussalam, the Kingdom of Cambodia, the Republic of Indonesia, the Lao People’s Democratic Republic (Lao PDR), Malaysia, the Republic of the Union of Myanmar, the Republic of the Philippines, the Republic of Singapore, the Kingdom of Thailand, Democratic Republic of Timor-Leste, and the Socialist Republic of Viet Nam, on the occasion of 48th ASEAN Summit in Cebu, Philippines on 8 May 2026.

RECALLING our shared commitment to the Kuala Lumpur Declaration on ASEAN 2045: Our Shared Future, along with the ASEAN Socio-Cultural Community Strategic Plan adopted during the 46th ASEAN Summit, which underlines ASEAN’s commitment in providing platforms and youth empowerment initiatives to contribute to sustainable socio-economic development and promoting ASEAN awareness, values and identity for a resilient community;

Download the full statement here.

The post The ASEAN Declaration on the Empowerment of Youth in Climate Action and Disaster Resilience appeared first on ASEAN Main Portal.

​

WE, the Heads of State/Government of the Member States of the Association of Southeast Asian Nations (ASEAN), gathered on the occasion of the 48^th ASEAN Summit, reaffirm our collective resolve to strengthen ASEAN’s unity, solidarity, and resilience in the face of increasingly frequent, intense, and complex disasters affecting our region.

We recognise that Southeast Asia remains one of the world’s most disaster-prone regions, facing a significant number of hazard events and affecting millions of our people. We further acknowledge that climate-induced disasters,      public health emergencies, biological, threats and cascading and compounding disaster risks are converging into a multi-hazard risk environment that demands faster, more anticipatory, and more coordinated regional action.

Download the full statement here.

The post ASEAN Leaders’ Statement on the ASEAN Convergence on Disaster Response: The ASEAN Strategic Protocol for Emergency and Comprehensive Transformation (ASPECT) Framework appeared first on ASEAN Main Portal.

​

New Ad Campaign Highlights Critical Role of Laboratory Testing in Patient Care and Urges Action Before Cuts Take Effect Washington, D.C. – The American Clinical Laboratory … Read More

The post ACLA Urges Congress to Pass RESULTS Act, Protect Patient Access to Laboratory Testing appeared first on American Clinical Laboratory Association.

​