News

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.

7 product categories will be subject to revised energy efficiency labeling requirements under a phased rollout beginning in June 2026.

The updated GN-00 guidance reduces classification uncertainty and creates clearer MDACS pathways for injectable dermal fillers in Hong Kong.

Malaysia’s MDA has issued major updates affecting medical device classification, special access exemptions, and management of obsolete and discontinued devices under the Medical Device Act 2012

New measures define vigilance management, inspections, PSURs, trend reporting, and reporting requirements in 17 pilot regions

China’s NMPA released a AI roadmap for smarter supervision across drugs, medical devices, and cosmetics regulation, covering AI-supported review, inspections, traceability, risk monitoring, and digital governance through 2035.

TFDA adopted ICH E9(R1) guidance on estimands, intercurrent events, missing data, and sensitivity analysis for drug clinical trial management.

China’s NIFDC releases 6 new technical guidelines for high-risk cosmetics, impacting hair dye, perming, and sunscreen product compliance.

Hong Kong introduces Primary Evaluation Phase 1 for NDAs, requiring pathway selection across 3 routes and reshaping drug registration strategy.

Hong Kong classifies classifcation of injectable products, impacting medical aesthetics and borderline products.

The reforms introduce new drug pricing rules, clarified conditional approval procedures, and tiered care measures.

TFDA eliminates legacy cosmetics review fees, reducing compliance costs for foreign companies.

CMDE maps 275 guideline updates, tightening requirements and giving manufacturers early visibility for planning and compliance.