NMPA Roundup June 2023

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

Policies

China Human Genetic Resources Rules Updated

China’s Ministry of Science and Technology published the “Details for the Implementation of the Human Genetic Resources Regulations” on June 1, 2023, effective from July 1, 2023.

The document optimizes the scope of application and reporting for collection, preservation, and international clinical trials. It also clarifies situations that do not require the filings to human genetic resources office. Read our comprehensive review.

Guidelines & Standards

How to Classify a Device? Guidance Reveals

The NMPA issued the “Guidance on Application Materials for Classification of Medical Devices” on June 14, 2023. It is applicable to both domestic and overseas manufacturers.

The guidance requires that, for imported devices, the approval certificate, IFU and other relevant materials should have the original version and Chinese translation. The approval certificate should include key information such as the classification in that country, the validity period of the document, etc.

View other material requirements and the pathway to fill your classification.

Twenty Standards Issued in One Day

NMPA published 20 industry standards on June 28, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions.

The mandatory standards include those for hemodialysis concentrates, implantable neurostimulators, and positive pressure breathing apparatus, etc. Check the full list.

Fast-track Approvals

Allurion’s Gastric Balloon Landed in Hainan

Allurion’s weight loss gastric balloon completed the first implantation in China at Hainan Ruijin Hospital on June 27, 2023. Overweight patients with a body mass index (BMI) greater than 27 can apply for this non-invasive treatment at the hospital.

China Med Device helped Allurion enter Hainan Real World Data program. We also connected Allurion with commercial partners.

Read more about what the device is and how to utilize the Hainan RWD program for your innovative or life-saving devices.

Review Report Released for Corindus’s Coronary Surgery Control Accessories

On May 16, 2023, the NMPA granted innovation approval to Corindus Inc., for its interventional coronary surgical control system accessories. It is the fifth imported innovative device approved by the NMPA so far in 2023, after Medtronic, Alcon, Ubiosis, and Conavi Medical’s approvals.

The NMPA issued the review report for the device on May 22, 2023. See our full report.

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-june-2023/