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NMPA Roundup December 2022

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Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in December 2022. These updates are presented by China Med Device, LLC, your partner in Chinese market access.

Policies

141 Class II Devices Proposed to UDI Starting June 1, 2024

NMPA proposed 141 Class II devices to be subject to UDI, according to “Implementation of the Third Batch of Medical Devices UDI” published on November 30, 2022. It asked manufacturers to prepare for UDI inclusion for three kinds of Class II devices: disposable products with large clinical demand, varieties included in the scope of medical insurance and medical cosmetic products.

The notice proposed that the above Class II devices manufactured after June 1, 2024, shall have unique identifiers. Read our comprehensive review.

Unapproved Breast Implant: DeneB Hyaluronic Acid’s First Injection in China

The DeneB hyaluronic acid, manufactured by South Korea’s BioPlus, completed the first injection in Hainan Lecheng Hospital on November 29, 2022.

The product was approved in several countries but not yet in China. Hainan Real World Data program provided a shortcut for BioPlus products to be launched in China. Look at more information on this product and Hainan RWD program.

Guidelines & Standards

Recombinant Human Collagen Guideline Issued

The NMPA released the “Review Key Points of Recombinant Human Collagen Injection Materials for Plastic Surgery (Draft)” on December 29, 2022, directing manufacturers on type test, preclinical testing, clinical evaluation, and regulatory submission.

Recombinant Human Collagen is a Class III device. The division of registration units should focus on factors such as the technical principle, structural composition, performance indicators and scope of application. View other highlights of the guideline.

Seven IVD Guidelines Ask for Feedback

NMPA issued seven IVDs draft guidelines on December 2, 2022, soliciting public opinions. Affected devices include blood glucose monitoring system, gene mutations reagents associated with tumor individualized therapy, etc. See the full list.

Fast-Track Approvals

Two Cardio Imaging Devices Gain Innovation Approval

NMPA granted innovation approvals to two radiology devices, used in combination for ultrasound imaging of intravascular lesions in coronary arteries. Read more information on the two devices.

About China Med Device, LLC 

China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China.

As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.

Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

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