Three Important Clinical Guidelines Issued in One Day

The NMPA published three new clinical guidelines on August 6, 2023, to direct manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions.

Three New Published Clinical Guidelines To Review

• Clinical evaluation regulation on predicate comparison of positron emission/X-ray computed tomography system
• Clinical evaluation guideline on predicate comparison of medical X-ray diagnostic equipment (Class III)
• Clinical evaluation plan on hemodialysis concentrates

For an English copy of any guideline above, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

About China Med Device

China Med Device 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, clinical standards, IVDs draft guidelines, eRPS, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

Feel free to contact us by email with any questions you may have about any related items.

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• Source: https://chinameddevice.com/clinical-guidelines/