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Search Results for: Medical Device Classification Catalog

NMPA Proposes Updates to Medical Device Classification Catalog

The NMPA Center for Medical Device Standardization Administration issued the “Notice on Soliciting Opinions on Adjustments of the Medical Device Classification Catalog” on August 7, 2025. Feedbacks need to be submitted by September 10, 2025. The document demonstrates NMPA’s commitment to improve regulatory clarity and align the risk-proportionate oversight with global regulatory best practices. For the medical device classification catalog,

CFDA New Medical Device Classification Catalogue Effective August 1st, 2018

CFDA Medical Device Classification Catalog draft was published August 31, 2017.  A year later, it became effective on August 1, 2018. New registration application after August 1, should follow the new classifications. After the release of the initial Catalog in 2002, CFDA has made several modifications to standardize the classification and streamline the registration process. The new Catalog is the

CFDA announced the new “Medical Device Classification Catalogue”!

On August 31, CFDA announced the new “Medical Device Classification Catalogue”. This new catalogue will be implemented on August 1ST, 2018. The revised medical device classification directory has significant implications for medical devices registrations or renewals. It is more robust and comprehensive as compared to its 2002 classificaiton version. We have summarized below the key points, revision background and comparision with the

NMPA Device Classification: A Rapidly Searchable and Updated Catalogue Available Now

Accurate medical device classification is the foundation of regulatory compliance, registration strategy, clinical planning, and market access in China. NMPA Classification Catalog was published in August 2017. After the release, several modifications have been made and many classification results have been issued reflect the latest technology and regulatory changes. China Med Device, LLC has consolidated the catalogs and results to

Shanghai Issues New Rules for Transferring Registered Medical Devices into Local Production

The Shanghai Municipal Medical Products Administration issued the “Provisions on Transferring Medical Devices with Existing Registration Certificates into Shanghai Production” on August 14, 2025. The regulation will take effect on October 1, 2025. This marks a significant step in aligning Shanghai’s local regulatory framework with national policy, and in facilitating the localization of already registered medical devices. Guangdong province has

Insights from the 2024–2025 Classification Results: Opportunities for Imported Combination Products Entering China

NMPA Center for Medical Device Standardization Administration released “Drug-Device Combination Products Classification Results (June 2024 to May 2025) on July 7. The document identifies 7 drug-led combination products and 46 device-led combination products. For combination products classification procedure, please click HERE For our white paper on combination products, click HERE Classification Results of Imported Combination Products Several imported products have

NMPA Classifies Non-Laser Light Source Device for Myopia and Amblyopia as Class II Device

NMPA released the Guideline for Classification of Medical Devices for Myopia Control and Amblyopia Treatment Involving Light Sources on July 16, 2025. The new guideline offers regulatory clarity for market entry of ophthalmic devices that use light to manage myopia or treat amblyopia. For international manufacturers, this marks a key opportunity to align with Chinese regulations and meet rising demand

NMPA Officials on Aesthetic Active Devices: A Strategic Overview for Global Manufacturers

In recent years, active devices based on laser, ultrasound, and radiofrequency technologies have gained significant popularity in the field of aesthetic medicine due to their remarkable effectiveness and diverse applications. These devices are widely used across medical institutions, aesthetic clinics, and even in home settings. However, the rapid expansion of this market has been accompanied by a rise in adverse

268 IVD Classifications Released by NMPA

The NMPA Medical Device Standardization Administration issued the “Third Batch of Medical Device Classification Results for 2024” on November 20, 2024. The document identifies 268 IVD reagents. It is the summary of classification requests submitted by overseas and domestic manufacturers. It also lists the contact numbers for each NMPA review department. If you want a face-to-face consultation, just as FDA’s

NMPA’s New Device Classification Rules Take Effect September 1, 2024

The NMPA published the “Announcement on Standardizing the Classification of Medical Devices” on May 11, 2024. It revises the classification processes for devices, combination products and newly developed medical devices, and standardizes the classification materials. NMPA will implement these new rules from September 1, 2024. Newly Developed Medical Devices China NMPA does not have De Novo process like FDA’s. When

List of Medical Device Mandatory Standards Released

NMPA issued the “List of Mandatory Standards Applicable to Medical Devices” on June 13, 2024, directing manufacturers for type testing and regulatory submission. Over 400 mandatory national and industry standards are included. Mandatory standards are legally enforced. Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that “medical device

NMPA Adjusts the Device Classification Procedure

The NMPA published the “Announcement on Standardizing the Classification of Medical Devices” on May 11, 2024. It revises the classification processes for devices, combination products and newly developed medical devices, and standardizes the classification materials. Newly Developed Medical Devices China NMPA does not have De Novo process like FDA’s. When a device is newly developed, NMPA mentioned in the document