Cisema | News about China product registration

Person standing at a bathroom sink examining a cosmetic tube and applying a small amount of cream to a fingertip, suggesting a skincare routine or product check in a clean, modern setting; relevant to consumer product use, safety evaluation, and regulatory compliance considerations for cosmetics in China and Asia-Pacific markets.

Friday, 10, April, 2026 / Published in China, Cosmetics & Ingredients, News

China’s NMPA Seeks Public Feedback on First Mandatory Toothpaste Safety Standard

On March 30, 2026, the National Medical Products Administration (NMPA) launched a public consultation on the mandatory national standard “General…

Laboratory scientist wearing a lab coat, protective goggles, gloves, and a blue hair cover carefully examining a small vial of liquid in a modern laboratory. A tray of sample vials sits on the bench in front, while analytical instruments and colleagues working in the background suggest a regulated research or pharmaceutical testing environment. The scene reflects laboratory quality control, product testing, and regulatory compliance processes relevant to product registration and market access in China and the Asia-Pacific region.

Friday, 10, April, 2026 / Published in Indonesia, News, Pharma & Biotech

BPOM Clarifies Indonesia–US Trade Agreement Impact on Pharmaceutical Regulation

On February 26, 2026, Indonesia’s National Agency of Drug and Food Control — Badan Pengawas Obat dan Makanan (BPOM) —…

Two office professionals sit at a desk in an office reviewing cosmetic and skincare product packaging alongside printed documents and binders. One person examines a product bottle while the other works on a laptop, suggesting regulatory compliance review, product documentation, and market access preparation for cosmetics entering China and Asia-Pacific markets. Shelves with files and product samples in the background reinforce a regulatory consultancy or product registration environment.

Thursday, 9, April, 2026 / Published in Cosmetics & Ingredients, News, Vietnam

Vietnam Authorities Step Up Cosmetic Recalls as Enforcement Tightens

In early 2026, the Drug Administration of Vietnam (DAV) issued several recall decisions affecting hundreds of cosmetic products. The actions…

Warehouse workers wearing high-visibility safety vests review inventory documents beside stacked boxes labeled “medical supplies” in a logistics facility, illustrating supply chain management, product documentation, and regulatory compliance processes relevant to market access and product distribution in China and Asia-Pacific markets.

Thursday, 2, April, 2026 / Published in Malaysia, Medical Devices, News

Malaysia MDA Tightens Oversight of Medical Device Procurement with MDA Circular No. 1/2026

On March 5, 2026, the Medical Device Authority (MDA) of Malaysia announced the implementation of “Medical Device Authority (PBPP) Circular…

Two professionals in a modern office review documentation for a HealthScreen glucose monitor while examining a computer display showing a product label with model number, barcode, and QR code. One person points to the code on the screen as the other reads the instruction leaflet beside a boxed device package. The scene suggests product labeling verification, documentation review, and regulatory compliance processes relevant to medical device product registration and market access in China and the Asia-Pacific region.

Wednesday, 1, April, 2026 / Published in Malaysia, Medical Devices, News

Malaysia Introduces New e-IFU & Digital Labelling Guidance for Medical Devices

Malaysia’s Medical Device Authority (MDA) has published the updated guidance document “MDA/GD/0026 – Requirements for Labelling of Medical Devices (7th…

Four professionals sit around a meeting table reviewing printed documents and binders related to product registration and regulatory compliance. A laptop screen displays “Product Registration Dossier,” while one person points to highlighted sections in a document. The group appears to be discussing documentation and approval steps for market access, with files, reports, and a tablet arranged on the table. The office setting includes organized binders and a framed Vietnam flag in the background, suggesting a regulatory consultancy environment supporting product registration and compliance processes for companies entering China and broader Asia-Pacific markets.

Wednesday, 1, April, 2026 / Published in Medical Devices, News, Vietnam

Vietnam Consolidates Medical Device Rules Under Decree 98 Framework

On March 6, 2026, Vietnam’s Ministry of Health issued “Consolidated Document No. 08/VBHN-BYT,” bringing together the current regulations governing medical…

Healthcare professional in a clinical laboratory or surgical setting holds and points to a bone model fitted with an orthopedic fixation plate and screws, illustrating medical device design and implantation for orthopedic treatment. The scene includes sterile instruments and medical equipment in the background, suggesting a regulated healthcare environment relevant to medical device regulatory compliance, product registration, and market access considerations in China and the Asia-Pacific region.

Tuesday, 31, March, 2026 / Published in China, Medical Devices, News

China NMPA Issues 26 Medical Device Standards Affecting Orthopedics, IVDs, & Software

China’s National Medical Products Administration (NMPA) issued “Announcement of the National Medical Products Administration on the Release of 26 Medical…

Two industrial workers wearing safety helmets and uniforms stand on a walkway using a tablet in front of large cooling towers at a power or manufacturing plant, with steam rising in the background; scene conveys industrial operations, site inspection, and digital monitoring relevant to regulatory compliance, product registration, and market access across China and Asia-Pacific.

Thursday, 26, March, 2026 / Published in China, HAF 604, News

China Signals Nuclear Market Expansion with HAF003 QA Reform and Global Nuclear Pledge

On March 18, 2026, the Department of Nuclear Safety Regulation under China’s Ministry of Ecology and Environment announced the formal…

Close-up of a healthcare professional using a handheld barcode scanner to scan labeled sterile medical device packages organized in a metal cart with multiple wire baskets. The sealed items include tubing, syringes, and clinical supplies, each with printed labels and QR codes for inventory tracking and traceability. The scene reflects hospital inventory management and medical device handling, relevant to regulatory compliance, product registration, and quality control processes in China and broader Asia-Pacific market access environments.

Thursday, 26, March, 2026 / Published in China, Medical Devices, News

China Mandates Full UDI Compliance for All Medical Devices by 2029

On March 13, 2026, China’s National Medical Products Administration (NMPA), together with the National Health Commission and the National Healthcare…

Healthcare professional in blue scrubs adjusts a patient’s head positioning as they lie on a hospital bed entering an MRI scanner, while another clinician observes brain scan images on a monitor in a clinical imaging room. The scene highlights medical diagnostics, imaging technology, and patient care processes relevant to healthcare systems, with potential implications for regulatory compliance, medical device approval, and market access in China and Asia-Pacific healthcare environments.

Wednesday, 25, March, 2026 / Published in China, Medical Devices, News

China NMPA Clarifies Pre-Review for Innovative Device Clinical Trials

On March 13, 2026, China’s National Medical Products Administration (NMPA) Center for Medical Device Evaluation (CMDE) issued the notice “Notice…

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