The National Medical Products Administration (NMPA) has initiated a major public consultation on 26 medical device registration guidelines, offering stakeholders across the healthcare industry an opportunity to shape regulatory standards. The consultation, announced on December 11, 2025, represents a significant step in China's ongoing efforts to modernize and strengthen its medical device regulatory framework.
High-Level Review Guidelines
Two guidelines under high-level review are included in this consultation. The first is a newly drafted registration guideline for glaucoma drainage devices used in minimally invasive glaucoma surgery (MIGS) implantation, addressing an emerging category of ophthalmic medical devices. The second is a 2025 revised version of the central venous catheter registration guideline, updating regulatory requirements for this critical vascular access device. Both guidelines reflect NMPA's commitment to keeping pace with technological advancements and clinical practice evolution.
Comprehensive Class II Device Coverage
The consultation encompasses 24 draft registration review guidelines for Class II medical devices, covering a diverse range of product categories. These include fundamental surgical and anesthesia supplies such as anesthesia reservoir bags, disposable syringes, and glass infusion containers. The guidelines also address specialized devices including implantable contraceptive systems, coronary guidewires, acupuncture needles, hemoglobin testing reagents, nasal airways, umbilical cord clamps, bone scissors, collagen-based wound dressings, suction heads, and disposable protective clothing. Additional coverage extends to various catheter-based devices and light-curing composite resin adhesives for dental applications.
Stakeholder Engagement and Timeline
Interested parties are encouraged to review the draft guidelines and submit their comments and suggestions using the official feedback form. The deadline for submissions is January 9, 2026, for the Class II device guidelines and January 10, 2026, for the high-level review guidelines. Contact information for each guideline is provided in the accompanying documentation. This consultation process demonstrates NMPA's collaborative approach to regulatory development, ensuring that industry expertise and practical considerations inform final guidance documents that will shape medical device registration requirements in China for years to come.
MEDTECH NEWS
NMPA Opens Public Consultation on 26 Medical Device Registration Guidelines
15 12 2025China's National Medical Products Administration (NMPA) has launched a comprehensive public consultation on 26 medical device registration guidelines, announced on December 11, 2025. The consultation includes two guidelines requiring higher-level review: a newly drafted guideline on glaucoma drainage devices for minimally invasive glaucoma surgery (MIGS) implantation and a 2025 revised version of the central venous catheter registration guideline. Additionally, 24 Class II medical device registration guidelines are open for comment, covering products such as anesthesia reservoir bags, implantable contraceptive devices, coronary guidewires, acupuncture needles, glass infusion containers, disposable syringes, hemoglobin testing reagents, nasal airways, umbilical cord clamps, bone scissors, collagen dressings, suction heads, disposable protective clothing, and various catheter-based devices. Stakeholders are invited to submit feedback by January 9-10, 2026, depending on the specific guideline. This initiative reflects NMPA's systematic effort to update and strengthen regulatory frameworks for medical device registration and evaluation across multiple product categories.