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NMPA Roundup October 2022

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

Policies

Registration Certificates Become Paperless

The electronic registration certificate for medical devices will be fully implemented, starting on November 1, 2022. The electronic certificate has functions such as instant delivery, SMS reminder, license authorization, code scanning query, online verification, and network-wide sharing.

It does not include product technical requirements, IFU and other accessories. Enterprises must first register in the online service hall of the NMPA and have real-name authentication. More information on Electronic Registration Certificates.

New China QMS Inspection Guidance Published

The NMPA issued the “Guidance on Inspection of Quality Management System for Medical Device Registration” on October 10, 2022, implementing from the day of release.

It stipulates the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. The applicant should establish QMS that is compatible with the entire product life-cycle process. It emphasizes QMS in the design process, articulating the requirements for each device category. View our comprehensive review on the QMS inspection guidance.

Guidelines & Standards

Six Draft Guidelines for Predicate-Comparison Ask Feedback

The NMPA published 24 draft guidelines in October soliciting public opinions. It includes six guidelines on clinical evaluation for predicate-comparison, affecting hip prosthesis, interbody cage, CT equipment, Class III X-ray diagnostic device and soft contact lens, etc. See the full list of predicate-comparison guidelines.

Twenty Industry Standards Issued in One Day

NMPA published 20 industry standards on October 17, 2022, to guide manufacturers for local type testing and regulatory approval. It includes four mandatory standards for contact lens, intraocular lens, radiofrequency ablation equipment and laser photocoagulation device. Check out the full list of the mandatory and recommended standards.

Fast-Track Approvals

Proton Therapy Equipment Gains Innovation Approval

Proton Therapy Equipment, by APACTRON Particle Equipment Co., received innovation approval on September 26, 2022. Read more information.

The NMPA released the final version of “Guideline on Clinical Evaluation of Proton/Carbon Ion Therapy System” on January 4, 2018. View our comprehensive review on the clinical guideline.

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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