NMPA News Roundup 202108

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

Policies

NMPA Standards Revisions Plan: Eleven Mandatory Standards to be Issued in 2021

The NMPA issued the final version of “2021 Medical Device Industry Standards Revisions Plan” on July 8, in which 77 medical devices and IVDs are affected. The Standards Revisions are aimed to facilitate manufacturers with local type testing and make standards more consistent with the international standards.

The final plan lists eleven mandatory standards, four of which are coronavirus treatment related. For more listed standards please click here

Drug Approval Certificate No Longer Needed for Combination Product Registration

NMPA issued the “Notice Regarding Drug-Device Combination Products Registration” on July 27, 2021, saying that the drugs contained in imported combination products do not have to be separately registered in China or have country-of-approval.

The notice also classifies that, if the applicant cannot determine its management category, it should apply to the Standards Management Center for the classification. Manufacturers can also refer to the NMPA published Classification Results. For more information please click here

Latest Classification Results for Combination Products

NMPA Standards Management Center published the “First Batch of Combination Products Classification Results in 2021” on July 7. Worth noted that overseas manufacturers pay more attention to the combination products, such as J&J’S Soft contact lens and Abbvie’s Risankizumab pre-filled portable dispenser. Please click here for the complete list

Guidelines

NMPA Finalizes Artificial Intelligence (AI) Software Classification Guideline

NMPA issued the “Artificial Intelligence Medical Software Classification Guideline” on July 8, 2021, to direct manufacturers for the classification and the corresponding clinical data and regulatory submission.

Making sure the software processes the medical device data is the key to determine if it is a medical device; If the software is to be Class II, it must not provide decision-making assistance. For more information please click here

Fast-track approvals

Two Cardio Devices Proceed to Fast-Track Review

CMDE granted four fast-track statuses in July 2021, among them are two cardio devices from Corindus  and Shenyang Pengyue. Please click here for the complete list

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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