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NMPA Roundup May 2023

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NMPA Roundup December 2023

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in May 2023. These updates are presented by China Med Device, LLC, your partner in Chinese market access.

Policies

15 Mandatory and 102 Recommended Standards to be Revised in 2023

The NMPA issued the final document of “2023 Medical Device Industry Standards Revisions Plan” on May 24, two weeks after the release of draft version. 15 mandatory and 102 recommended standards will be revised or established.

The 15 industry mandatory standards impact the devices such as blood pressure sensor, bone joint implant devices, Bone joint implant device Metal bone plate, laser treatment machine, cardiopulmonary diversion system, hemoperfusion equipment, dentistry hydrostatine device, etc. See the full list.

Guidelines & Standards

Intracranial Coil and Stent Retriever Guidelines Ask Your Feedback

The NMPA issued a notice titled “Information Collection from Enterprises and Institutions Related to the Preparation of the Guideline for Intracranial Coils and Guideline for Stent Retrievers” on May 17, 2023. The deadline is May 31, 2023.

According to Chinese Circulation Journal published in 2022, two out of every five deaths in China were due to cardiovascular disease (CVD). It is estimated that about 330 million patients suffer from CVD in China. Read more information.

Recombinant Collagen Raw Materials and Wound Dressings Guidelines Published

The NMPA issued “Guideline on Recombinant Humanized Collagen Raw Materials” and “Guideline on Recombinant Collagen Wound Dressings” on May 23, 2023.

The 54-page collagen raw materials guideline stipulates the four vital points for registration review as material performance study, material Immunological safety, biological risks, and stability and direct contact container study.

The Guideline on Recombinant Collagen Wound Dressings confirms that the collagen wound dressings are Class II device. When classified into subcategories of -01 wound dressing, -04 gel dressing and -08 liquid, paste dressing, they can be exempted from clinical trial. View highlights from the guidelines.

Innovation Approvals

Imported Intravascular Imaging Equipment Gains Innovation Approval

On May 16, 2023, the NMPA granted innovation approval to Conavi Medical Inc., from Canada, for its intravascular imaging system. It is the fourth imported innovative device approved by the NMPA so far in 2023, after Medtronic, Alcon, and Ubiosis’ approvals.

Read the NMPA’s opinion on the intravascular imaging system.

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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