News

MDA will issue only electronic establishment licenses, affecting medical device manufacturers, importers, and distributors.

Indonesia removes IDAK renewals, mandates SDAK and IPAK transitions, and shortens correction timelines under risk-based licensing.

New WHO CRP pathway enables faster MDA review of eligible WHO-prequalified IVDs.

New policy streamlines COVID-19 Antigen RDT registration and renewal applications.

New MDA guidance introduces a risk-based framework for managing post-registration medical device changes, including software updates and SaMD.

Applicable for new registrations, renewals, and variations, the Standardized Medical Device Specification Template improves data consistency and regulatory review efficiency.

Vietnam's temporary suspension of key food registration provisions creates a transitional regulatory environment, particularly affecting health supplement companies.

The 2025 Drug Evaluation Report provides insights into key application trends, review activities, and developments across China's pharmaceutical sector.

The full implementation of the reliance program creates new opportunities for manufacturers to accelerate regional market entry by strategically leveraging approvals across both jurisdictions.

The reformed framework overhauls policy to strengthen innovation while tightening evidence, supply, and compliance requirements.

The framework establishes filing rules, protection scope, and transitional requirements affecting innovative and overseas-originator drug applications in China.

Malaysia’s latest regulatory updates expand electronic labelling for pharmaceuticals and simplify medical device label requirements for foreign manufacturers.

Summary of 2025 MFDS trends covering medical device approvals, import dynamics, and the shift toward AI and software-based regulation.

The updated technical guideline expands regulatory expectations for manufacturing, impurity control, advanced analytics, stability studies, and biosimilar comparability.

China’s NMPA and six government agencies issued new measures that strengthen compliance requirements, anti-bribery controls, and oversight of pharmaceutical promotion activities.

The new framework introduces a distinct regulatory pathway for emerging therapies, with major implications for clinical development and market strategy.

China’s SAMR has released draft advertising review measures that would increase oversight of livestreaming and digital marketing while streamlining certain compliance requirements for regulated products.

The three revised CCC certification standards for low-voltage electrical equipment introduce new testing and compliance requirements.

New guidance highlights the need for earlier China development planning whenrelying on global trials, foreign clinical data, or multinational development strategies

New customs measures taking effect in December 2026 will reshape how cosmetics are inspected, cleared, labeled, and electronically verified in China.