China

Learn how MARA imported feed registration in China works: Product eligibility, registration requirements, China-based agents, testing and more.

Understand the key differences between China Medical Device GMP and ISO 13485, including requirements for quality management, suppliers, facilities and documentation.

Discover how leveraging Real World Data generated in the Greater Bay Area can accelerate market entry for medical products in China.

Learn about China's Unique Device Identification (UDI) system and how to navigate China’s evolving medical device market.

Track all imported Class II and III medical device approvals in China with this monthly updated NMPA submission tracker.

Learn the key requirements for China food labeling compliance: mandatory label content, ingredient declarations, imported food requirements, and more.

Learn the latest China NMPA registration fees for imported and domestic drugs and medical devices.

Understand the pathway for intraocular lens (IOL) registration in China, including NMPA requirements and key compliance steps.

A complete guide to China hyaluronic acid registration, covering classification, NMPA requirements, and compliance steps for manufacturers.

Practical China medical device glossary explaining NMPA terms, with clear comparisons to US FDA and EU MDR terminology.

Learn 5 key steps for China dental medical device registration, covering classification, biocompatibility testing, and legal agent selection.

Learn how a smart clinical trial strategy for medical devices in China can speed up NMPA approval and bring your product to market faster.

Get answers to common China medical device and IVD registration questions, from NMPA classification rules to testing and renewal requirements.

Learn how China medical device risk classification works under NMPA rules and see common compliance pitfalls to avoid.

Learn how China IVD risk classification works under NMPA rules and see common compliance pitfalls to avoid.

Gain clarity on often-misunderstood China Manufacture License (CML) requirements, including SELO approval, demo products, and CSEI audits.

Identify China medical device GMP gaps and prepare QMS, supplier, data, and inspection controls before NMPA market entry.

China’s 15th Five-Year Plan signals stronger support for innovative drugs, advanced medical devices, reimbursement reform, and NMPA regulatory pathways.

Learn about Cisema’s redesigned website with faster performance, clearer navigation and expanded Asia Pacific coverage.

China proposes ICH E6(R3) Annex 2 implementation from January 2027, with public comments open for one month from August 10 2026.

The guideline introduces more detailed evidence requirements for Hong Kong and Macao drug imports while retaining a streamlined pathway for products already approved under the GBA Connect scheme.

TC21-2026-02 introduces stricter chemical limits, enhanced safety requirements, and a 2027 compliance deadline for toys and children’s vehicles.

TC07 clarifies how companies must convert eligible CCC self-declarations to third-party certification before mandatory compliance deadlines.

The draft clarifies when CDE may issue written supplementary information requests and when major deficiencies identified during review may instead lead to a non-approval conclusion.

The R&D import whitelist scheme streamlines customs clearance while maintaining specific eligibility, traceability, and risk-control requirements.

Learn the proposed changes to China’s drug traceability system requirements and the key considerations for industry stakeholders.

Understand what China’s revised medical device GMP means for quality management and digital compliance, alongside changes to classification, emerging technologies, and online sales.

Brands must audit ingredients, suppliers and packaging before January 2028 to ensure compliance with GB 7916-2026.

By shifting the focus beyond lowest-price bidding, the new policy rewards innovation, clinical performance, and long-term value in public hospital procurement.

Companies can benefit from expanded toxicology data exemptions, simplified cosmetics registration procedures, and more efficient compliance pathways

Explore the latest data on China’s clinical research landscape, including record trial activity, shorter development timelines, and emerging R&D trends.

New NCI rules reduce administrative burden, streamline dossiers, and expand opportunities to reuse existing safety data.

Review China's new draft standards for cosmetic cheilitis and contact urticaria before the August 15, 2026, consultation deadline.

New data on cosmetic registrations, ingredient filings, safety assessments, and standards development reveals key compliance trends in China.

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

China NMPA adds four new cosmetic testing methods effective July 2026, impacting compliance and safety assessment strategies.

China’s NMPA is incorporating 18 revised cosmetics standards into the Safety and Technical Standards for Cosmetics.

China issues technical guidance clarifying when post-filing updates to new cosmetic raw materials are permitted.

China will launch a cosmetic e-label pilot on February 1, 2026. Explore the labeling requirements and what preparation is required.

NMPA outlines cosmetics regulation reforms, aiming to expand non-animal testing, streamline registration, and drive ingredient innovation.

China’s 2024 NIFDC Cosmetics Review Report showcases soaring registrations and key opportunities for global beauty brands.

Discover how new China NIFDC guidelines streamline filings for cosmetic raw materials, helping beauty brands enter the market faster.

China’s CDE 2025 clinical trial report covers 4,900 studies registered in 2024, highlighting key trends in drug development, therapeutic areas, and trial timelines.

China’s 2025 IVD clinical trial exemption catalogue expands to 445 products, affecting clinical evidence requirements and IVD registration in China.

China’s NMPA launches a 2026–2028 action plan to strengthen cosmetic manufacturing quality systems, raising compliance expectations.

Learn about the new standards of the Chinese Pharmacopoeia 2025 Edition, implemented Oct 1, 2025, as well as relevant compliance strategies.

Chinese Pharmacopoeia 2020 edition was translated into English and officially published by the Chinese CPC on March 14, 2023.

The NMPA’s 2024 national drug sampling covered 136 varieties and 20,604 batches, achieving a 99.4% compliance rate.

The 12th national VBP round introduces tighter quality, manufacturing, and IP requirements that pharmaceutical companies must meet to compete.

New NMPA CDE guidelines define CTMP and GTMP boundaries, affecting development strategy, CMC planning, and regulatory engagement in China.

China's updated National Essential Medicines List expands access to innovative medicines, creating new opportunities and strategic considerations for pharmaceutical companies.

China's NMPA expands priority review eligibility for chemical API marketing authorization applications, supporting domestic API production and drug supply.

China's 2026 enforcement priorities expand scrutiny of pharmaceutical sales, procurement, pricing, data security, and compliance across the healthcare sector.

MIIT expands China's RoHS product scope, adds four restricted substances, and introduces new exemptions with compliance deadlines from August 2027.

NMPA issues Medical Device Clinical Evaluation Exemption 2025 impacting international medical device registration strategies

Manufacturers seeking MRI registration in China must meet expanded technical, software, and validation requirements.

The new documents clarify expectations for Tier III variants, companion diagnostic clinical evaluation, tissue and plasma registration, and HLA-B*58:01 analytical validation.

China's new BCI medical device guidance establishes classification and naming principles, giving manufacturers a clearer pathway to NMPA registration.

New NMPA packaging size guidance encourages drug applicants to align pack sizes with clinical use, patient needs, and sustainability goals.

The latest Guidelines raise the compliance bar for online prescription drug sales, with stricter oversight for pharmacies and platforms.

Draft standards would introduce a unified 37-digit barcode system and update technical requirements for veterinary equipment supplied to China.

New Hainan MPA guidance clarifies how Lecheng real-world evidence can support imported product registration, labeling updates, and post-approval activities

New Trial CCC rules strengthen factory oversight, product consistency, and quality management requirements for manufacturers.

Learn how China's GB 7718-2025 food labeling standard and new digital label rules affect imported foods before the March 2027 compliance deadline.

New rules strengthen data governance and raise sponsor oversight duties from September 2026.

New ethics guidelines clarify consent, privacy, security, and governance expectations for human genetic data research in China.

China Customs has revised the 2026 sampling inspection program, adding and removing product categories that may face border inspections.

China approves new food ingredients, additives, and food-contact materials, creating new formulation and compliance considerations

New CCC requirements add GB 47372-2026 as a mandatory certification standard and require certificate conversion for affected products

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

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.

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

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

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

The new GMP for medical devices, effective Nov 1 2026, introduces stricter quality, personnel, and supplier controls.

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.

China’s NMPA updated the Medical Device Classification Catalogue, revising requirements and classifications for 31 product categories.

Malaysia and China launch a regulatory reliance pilot to streamline IVD medical device registration and accelerate cross-border market access.

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

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

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

CNCA issued 11 trial CCC certification implementation rules for fuses, electric tools, welding machines, automotive components, and safety glass.

China’s MIIT and nine ministries introduce a new AI ethics review and services framework establishing tiered oversight, compliance obligations, and governance pathways for AI activities in China.

China issues new guidelines on medical device adverse event risk evaluation and periodic report review, tightening post-market surveillance requirements

China’s CMDE releases a new IVUS registration review guideline, defining technical, clinical, and testing requirements for NMPA medical device registration

The NMPA announced a total of 28 updates on the classification catalogue for medical devices including 15 classification changes and 13 content updates.

China’s NMPA updates cosmetics testing methods, adding CBD detection and tighter impurity controls impacting global compliance.

SAMR introduce stricter recall and compliance requirements for enterprises involved in cross-border e-commerce retail imported food.

China’s NMPA releases 2025 annual report on medical device standardization, highlighting growth, innovation, and international alignment.

China’s NMPA formally includes black ginseng extract, hydrolyzed sodium hyaluronate zinc, and galactomannan in the IECIC.

China’s National Medical Products Administration has issued its 2026 medical device standards plan, introducing 80+ new and revised standards

The draft 2026 catalogue defines which Class III medical devices would require clinical trial approval before trial initiation.

China NMPA’s 2025 report highlights growth in medical device approvals, including advanced imported devices.

China releases guiding principles for benefit-risk assessment using multi-regional clinical trial data to support global drug development.

China’s NMPA issues new guidance on clinical trial protocol pre-review for innovative devices, impacting overseas fast-track approvals.

China’s NMPA has opened consultation on a draft mandatory toothpaste safety standard that could tighten product requirements.

China releases new subject selection guidance for anti-tumor drug bioequivalence and pharmacokinetic studies.

China’s CCC mark pilot reform requires traceability QR codes for power banks, electric bicycles, and gas appliances.

China's HAF003 reform and participation in the "Tripling Nuclear Energy Declaration" signals stricter compliance and new opportunities.

China’s NMPA mandates full UDI coverage for all medical devices by 2029, linking compliance to registration, reimbursement, and market access.

China clarifies GACC Order 280 rules for imported food registration and customs declarations ahead of June 2026 enforcement.

The 26 new medical device standards cover orthopedic implants, IVDs, active devices, and software risk management.

Hong Kong’s Department of Health introduces Pre-NDA meetings to streamline new drug registrations under the “1+” mechanism.

The Department of Health has mandated MDACS listing for public procurement eligibility — see which devices are affected and how to prepare.

China’s CMDE announced revisions to the registration review guideline for aesthetic sodium hyaluronate injectable fillers.

China’s CDE released three 2026 trial guidelines on Phase III design for chronic insomnia, neuropathic pain, and depressive disorders.

NMPA CDE clarifies CMC expectations for preventive mRNA vaccines, focusing on LNP control, impurity management, and lifecycle comparability.

China’s CDE issued trial guidance on CMC lifecycle changes for cell therapies, emphasizing comparability and risk-based quality assessment.

China’s NMPA will apply ICH M14 to non-interventional real-world evidence safety studies initiated on or after its January 2026 announcement.

The draft 2026 catalogue defines which Class III medical devices would require clinical trial approval before trial initiation.