China Medical Device Approval Tracker: Imported Class II & III Devices
Track all imported Class II and III medical device approvals in China with this monthly updated NMPA submission tracker.
September 29, 2026
6 China Infant Formula Labeling Mistakes Manufacturers Keep Making
Avoid common China infant formula labeling mistakes involving registration, allergen statements, date marking, milk-source claims, production changes, and existing inventory.
September 29, 2026
China Health Food Approval Tracker: 2026 SAMR Data
Track China’s 2026 imported health food approvals, monitor SAMR regulatory trends, and compare market activity by category and source with Cisema’s interactive tracker.
September 29, 2026
China Manufacture License: 4 Common Misconceptions Foreign Manufacturers Should Rethink
Gain clarity on often-misunderstood China Manufacture License (CML) requirements, including SELO approval, demo products, and CSEI audits.
September 28, 2026
How China Medical Device Clinical Trial Strategy Affects NMPA Approval Timelines
Learn how a smart clinical trial strategy for medical devices in China can speed up NMPA approval and bring your product to market faster.
September 28, 2026
5 Key Considerations for China Dental Medical Device Registration
Learn 5 key steps for China dental medical device registration, covering classification, biocompatibility testing, and legal agent selection.
Dental procedure in a clinical setting where two masked dental professionals in white lab coats perform an oral examination and treatment on a patient in a dental chair using specialized instruments and suction equipment, illustrating professional healthca
September 28, 2026
FAQ: China Medical Device & IVD Registration
Get answers to common China medical device and IVD registration questions, from NMPA classification rules to testing and renewal requirements.
September 28, 2026
What Japanese Manufacturers Need to Know About Vietnam Cosmetics Registration
From registration to tariffs and CPTPP benefits, here’s what Japanese cosmetics manufacturers need to know about Vietnam’s cosmetics market.
September 28, 2026
How to Meet Vietnam Medical Device Dossier Requirements for Registration
Learn how to prepare a compliant dossier for Vietnam medical device registration in this guide for foreign manufacturers.
September 28, 2026
What's the Difference? Fast-Track vs Standard Medical Device Registration in Vietnam
Explore Vietnam’s fast-track and standard medical device registration pathways and the role of reference approvals in shortening timelines.
September 28, 2026
What Is the Vietnam Cosmetic Product Registration and Notification Process?
Cosmetic product registration and notification in Vietnam involves specific processes, fees, and timelines under the ASEAN Cosmetic Directive.
September 28, 2026
How the Vietnam Medical Device Change Notification Process Works
Learn how to manage medical device renewals, variations, and change notifications in Vietnam with step-by-step MOH submission guidance.
September 28, 2026
How Does the Singapore HSA Medical Device Registration Process Work?
Learn all about HSA medical device registration in Singapore with timelines, fees, and AR requirements in this step-by-step guide.
September 28, 2026
How Singapore Accelerates ASEAN Market Entry for Medical Devices, Pharma, & Cosmetics
This guide explains Singapore’s HSA regulatory system and why it is a strategic first step for entering Southeast Asian markets with medical devices, pharmaceuticals, and cosmetics.
September 28, 2026
5 Step Guide to Singapore Cosmetic Product Registration
Navigate cosmetic product registration in Singapore in this guide offering key insights and practical tips.
September 28, 2026
5-Step Guide to Cosmetic Product Registration in Malaysia (NPRA Cosmetic Notification)
Learn how to register cosmetics in Malaysia under NPRA’s notification system aligned with the ASEAN Cosmetic Directive.
September 28, 2026
How Is SaMD & AI Medical Software Regulated in China? NMPA Requirements Guide
Learn how China regulates SaMD, including NMPA risk classification, registration, clinical evaluation, cybersecurity, AI, and software changes.
September 24, 2026
When Is a Clinical Trial Required for China NMPA Medical Device Registration?
Find out when a clinical trial is required in China and when clinical evaluation, exemptions, overseas data, or other evidence may be sufficient.
Detailed Description (for accessibility) A professional stock photo featuring an East Asian male doctor in his late 30s or early 40s wearing a crisp white lab coat over dark blue scrubs, with a stethoscope draped around his neck.
September 17, 2026
Is a Foreign Halal Certificate Valid in Indonesia? Requirements Explained
Understand Indonesia’s foreign halal certificate requirements, including covered categories and BPJPH registration routes.
September 4, 2026
Entering China’s Feed Market: MARA Imported Feed & Feed Additive Registration Requirements for Foreign Manufacturers
Learn how MARA imported feed registration in China works: Product eligibility, registration requirements, China-based agents, testing and more.
September 1, 2026
Understanding Local Testing for Medical Devices & IVDs in Indonesia: Requirements & Registration Guide
Learn when local testing is required for medical devices and IVDs in Indonesia, which products are affected, and how testing impacts registration requirements.
An Indonesian male medical professional in profile, wearing dark blue scrubs, a blue surgical cap, safety glasses, a white mask, and a blue-tubed stethoscope, presses a button on a dual-monitor medical control panel in a clinical operating setting.
August 31, 2026
What Are Malaysia NPRA’s License Requirements for Pharmaceutical Products?
Learn about NPRA license requirements in Malaysia, including license types, application steps, fees, processing timelines, renewals, and new application requirements.
August 31, 2026
China Medical Device GMP vs ISO 13485: Key Differences Explained
Understand the key differences between China Medical Device GMP and ISO 13485, including requirements for quality management, suppliers, facilities and documentation.
Two Chinese medical device technicians, a woman and a man wearing white lab coats, surgical caps, face masks, and protective gloves, stand side by side in a sterile cleanroom environment.
August 26, 2026
5-Step Guide to Taiwan Medical Device Classification (TFDA)
How to determine medical device classification in Taiwan: the TFDA catalogue, the 16 categories, Class I-III risk levels, and what to do when no item matches.
August 21, 2026
Guide to Indonesia Medical Device Post-Registration Changes: Notification, Variation, or New Registration
Learn when medical device and IVD changes in Indonesia require a notification, variation, or new registration, and how to maintain ongoing regulatory compliance.
August 5, 2026
How Vietnam Medical Device Registration Works (Timelines, Fees, & AR Strategy)
Gain an overview of the medical device registration process in Vietnam with timelines, fees, and Authorized Representative requirements.
August 4, 2026
Understanding the ASEAN Medical Device Market: Comparing 6 Strategic Markets
Explore the medical device market opportunities, regulations, and registration pathways across Malaysia, Singapore, Vietnam, and other key ASEAN countries.
August 4, 2026
How Does GBA Real World Data Support China NMPA Approvals?
Discover how leveraging Real World Data generated in the Greater Bay Area can accelerate market entry for medical products in China.
July 31, 2026
What Is China’s UDI System & How Does It Affect Medical Device Registration?
Learn about China's Unique Device Identification (UDI) system and how to navigate China’s evolving medical device market.
July 31, 2026
How Does Indonesia Cosmetic Notification Work? A Guide to Legally Selling Cosmetics in Indonesia
Learn how overseas cosmetic manufacturers can meet Indonesia’s BPOM notification requirements and legally bring their products to market.
July 30, 2026
Essential Guide to China Food Labeling Compliance
Learn the key requirements for China food labeling compliance: mandatory label content, ingredient declarations, imported food requirements, and more.
July 14, 2026
How to Comply with Indonesia’s Cosmetic PIF Requirements
Learn Indonesia's cosmetic PIF requirements, ingredient compliance rules, and common pitfalls to avoid.
July 13, 2026
How China IVD Risk Classification Determines Your NMPA Registration Pathway
Learn how China IVD risk classification works under NMPA rules and see common compliance pitfalls to avoid.
July 13, 2026
A Guide to South Korea Medical Device Regulation for Global Manufacturers
Understand South Korea’s medical device regulations, from classification to approval and post-market compliance.
July 10, 2026
Understanding South Korea's Strategic Roadmap for Digital Medical Product Safety Management
Learn how MFDS’s Digital Medical Product Safety Management Roadmap will shape future compliance requirements for digital medical products in Korea.
Stock photo of a Korean man in his early 30s sitting comfortably in a bright, contemporary apartment in South Korea, casually reviewing a health monitoring app on his smartphone while wearing a small continuous glucose monitor (CGM) sensor on his arm.
July 10, 2026
What Is the MFDS? Understanding South Korea’s Medical Device Authority
Learn how South Korea’s Ministry of Food and Drug Safety regulates medical devices, including classification, application review and post-market duties.
July 10, 2026
Explained: South Korea Medical Device Classification (Class I, II, III, & IV)
Learn how South Korea medical device classification works under the MFDS.
Stock photo of an adult South Korean patient wearing a continuous glucose monitor (CGM) on the upper arm during a routine appointment in a modern hospital outpatient clinic
July 10, 2026
China NMPA Fee Catalogue for Drugs & Medical Devices
Learn the latest China NMPA registration fees for imported and domestic drugs and medical devices.
July 10, 2026
A Guide to Dossier Preparation for Indonesia Medical Device Registration
Discover the documents required for Indonesia medical device and IVD registration, including dossier requirements, legalization, submission and common FAQs.
Stock photograph of an Indonesian adult man performing a routine blood glucose test at home, one hand holding a blue handheld blood glucose meter with a test strip inserted while the other hand gently presents an index finger
July 9, 2026
What Are the Medical Device Renewal Timelines Across ASEAN?
Learn about license validity and renewal rules for medical devices in Southeast Asia.
July 9, 2026
How to Fast-Track Medical Device Registration in Southeast Asia
Explore fast-track medical device registration in Southeast Asia, cut timelines by 6–12 months, and accelerate market entry with Cisema.
July 9, 2026
Essential Guide to Malaysia Medical Device Registration: Process, Timeline & Fees
Learn the Malaysia medical device registration process, covering MDA requirements, classification, CAB assessment, timelines, costs, and Authorised Representative roles.
July 9, 2026
A Regulatory Glossary for Medical Devices in China
Practical China medical device glossary explaining NMPA terms, with clear comparisons to US FDA and EU MDR terminology.
July 9, 2026
A Complete Guide to China Hyaluronic Acid Registration
A complete guide to China hyaluronic acid registration, covering classification, NMPA requirements, and compliance steps for manufacturers.
July 9, 2026
What Is a Malaysia Conformity Assessment Body (CAB)?
Learn about Malaysia’s conformity assessment bodies — including CAB evaluation routes, risk classifications, and MDA registration steps.
July 9, 2026
How China Medical Device Risk Classification Determines NMPA Registration Pathway
Learn how China medical device risk classification works under NMPA rules and see common compliance pitfalls to avoid.
July 9, 2026
A Guide to Malaysia Medical Device Registration Dossier for Class B, C & D Devices
Understand the key components of the Malaysia Medical Device Registration Dossier for Class B, C and D device submissions.
July 9, 2026
A Practical Guide to Medical Device Registration in Indonesia
Learn how to register medical devices in Indonesia, including Authorized Representative rules, classification, dossiers, timelines, and fees.
Three masked surgical staff in green operating room attire stand with folded arms beside a patient lying on an operating table, with medical monitors and X-ray images displayed in a dimly lit operating room.”
July 9, 2026
Key Requirements for Indonesia Halal Medical Devices: What Manufacturers & Importers Need to Know
Learn which products are covered by Indonesia's halal framework, the labeling and manufacturing obligations, and phased compliance timelines.
A healthcare worker in a white coat checks a seated patient’s blood pressure while another medical staff member in green scrubs stands nearby holding a clipboard in a bright clinic setting.
July 9, 2026
How to Enter China’s Intraocular Lens (IOL) Market: NMPA Registration Requirements for Foreign Manufacturers
Understand the pathway for intraocular lens (IOL) registration in China, including NMPA requirements and key compliance steps.
A close-up of an eye with a transparent intraocular lens held by surgical tweezers positioned in front of the pupil, illustrating ophthalmic medical device use. The visual supports themes of regulatory compliance, product registration, and market access
July 9, 2026
A Guide to Malaysia Drug–Medical Device Combination Products: Classification & Regulatory Pathways
Learn how Malaysia classifies drug–medical device combination products and how the PMOA determines pathways and compliance responsibilities.
Laboratory professional in protective eyewear, hair cover, sterile gown, and blue nitrile gloves examining a filled syringe in a clean laboratory environment.
July 9, 2026
Understanding Indonesia Halal Cosmetic Certification Requirements
Learn how Indonesia halal cosmetic certification works, including BPJPH requirements, halal labeling rules, ingredient compliance, and registration obligations.
July 9, 2026
What Is Indonesia Halal Certification for Health Supplements? What Manufacturers & Importers Need to Know
Understand Indonesia halal certification requirements for health supplements, including BPJPH registration, ingredient review, and halal labeling obligations.
A person dressed in a flowing black hijab holds a small red capsule delicately between their fingers, presenting it toward the camera. Their expressive eyes are sharply focused forward, while the softly blurred background.
July 9, 2026
Understanding Digital Medical Device Clinical Trials in South Korea: The MFDS Framework
Understand MFDS clinical trial requirements for digital medical devices, including real-world evidence, data-based studies, and software validation expectations.
July 9, 2026
China Medical Device GMP Readiness: A Checklist for Overseas Manufacturers
Identify China medical device GMP gaps and prepare QMS, supplier, data, and inspection controls before NMPA market entry.
Stock photograph inside a modern medical device manufacturing facility in China, a Chinese quality assurance engineer wearing a cleanroom gown, hair cover, and appropriate cleanroom attire standing beside a production technician.
July 2, 2026
Cisema Expands into South Korea
Supporting foreign manufacturers entering South Korea with regulatory services for medical devices, IVDs, and quasi-drugs.
Seoul skyline in the early evening
June 1, 2026
China’s 15th Five-Year Plan: Implications for Drugs, Medical Devices, & Market Access 
China’s 15th Five-Year Plan signals stronger support for innovative drugs, advanced medical devices, reimbursement reform, and NMPA regulatory pathways.
Chinese flag against a blue sky
May 8, 2026
Breaking Into Southeast Asia’s Dental Market: 3 Things Manufacturers Need to Get Right
Enter Southeast Asia’s dental market with a clear strategy: navigate regulatory complexity, sequence market entry, and retain control of registrations to scale efficiently.
Malaysian dentist with a patient in a well lit dental clinic.
May 6, 2026
Cisema Launches a Redesigned Website
Learn about Cisema’s redesigned website with faster performance, clearer navigation and expanded Asia Pacific coverage.
Cisema Logo: Navigating Regulation, Empowering Innovation
May 6, 2026
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