NMPA Roundup August 2023

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

Policies

NMPA Down-Classified Five Class III Medical Devices

NMPA reclassified certain neurosurgical, cardiac surgery, orthopedic, and hemodialysis, radiological equipment and devices and modified intended use for some with an announcement on August 21, 2023.

Among them, five devices are down classified from Class III to Class II. For the full list please click HERE

Great Bay Area (GBA) will be Impacted by New Hong Kong Medical Device Procurement

China’s Greater Bay Area is one of the most affluent and populated regions with close to 86.17M people, more than the entire size of Germany. To sell in GBA Hong Kong medical device needs China NMPA approval beforehand, the products need to be used in Hong Kong or Macau public hospitals. The Hong Kong Department of Health (DH) is implementing a new medical device procurement policy, effective from June 21, 2023. For our comprehensive article please click HERE

Four Foreign Manufacturers Registered Raw Materials in Master File in August

The NMPA issued a NMPA renewed the list of raw material master files on August 14, 2023. Four foreign manufacturers became master file owners for their raw materials or key components in August. For the full list please click HERE

Guidelines & Standards

NMPA Published Benefit-risk Assessment Guideline

NMPA released the “Medical Device Benefit-risk Assessment Guideline (2023 revised version)” on July 18, 2023. Through the benefit-risk judgment table in which standard review consideration factors are listed, the document aims to improve the predictability, consistency, and transparency of the pre-market review process. Please click HERE for benefit and risk factors and the examples NMPA gives.

Seventy-Six Standards of 9706 Series Listed by NMPA

The NMPA summarized 76 Medical Electrical Standards, GB 9706 Series, which is equivalent to IEC60601.

The standards have been effective since May 1, 2023. For active product manufacturers with existing NMPA certificates, grace period has been granted to comply by December 31, 2025. Click HERE for the complete list of GB 9706 standards.

NMPA Issued Eight Guidelines in August

The NMPA published eight device guidelines in August 2023, to direct manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Among them are four evaluation guidelines on predicate comparison. Click HERE for more information

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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• Source: https://chinameddevice.com/nmpa-august-2023/