Blog

September 18, 2020

Hainan Medical Pilot Zone: Device Importation Processing Time Shortened to Three Days

Hainan government published “The System Integration Innovation Reform Plan of Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port”, unveiling first-of-its-kind policies on permission to import drugs […]
September 9, 2020

NMPA: Seven Guidelines Issued in August

NMPA published seven pathology and clinical chemistry guidelines in August, to direct manufacturers for clinical trial, local type testing and regulatory approval: Clinical trial guideline on anti-tumor companion diagnostics (CDx) […]
September 7, 2020

Two AI Software Approved for Diabetic Retinopathy

NMPA granted Innovation Approvals of two diabetic retinopathy (DR) assistant diagnosis software, to Shenzhen Guiji and Shanghai Yingtong. It is the first time that AI technology is approved for ophthalmology […]
September 3, 2020

China UDI Database Launched: 97,258 Device Identifiers Already Uploaded

NMPA launched Unique Device Identification (UDI) Database on its website on August 10, 2020, facilitating the implementation of China UDI system for the first group of devices which will take […]
August 31, 2020

China MRI Draft Guideline Published

NMPA published “Clinical Evaluation Guideline on Medical Magnetic Resonance Imaging (MRI) System Comparing the Similar Device (draft)” on August 13, 2020. The 19-page document provides manufacturers detailed pathway for clinical […]
August 21, 2020

NMPA News Roundup July 2020

Here’s the latest NMPA regulatory and clinical affairs news for medical device and IVDs pros for July 2020. These updates are presented by China Med Device, LLC, your partner in […]
August 18, 2020

NMPA on IVD Equipment and Hemodialyzer

NMPA published two Q&A on IVD equipment and hemodialyzer respectively, addressing two frequently asked issues: Q: When applying for an in vitro diagnostic equipment registration change, is it necessary to […]
August 13, 2020
China Med Device

NMPA: Fourteen Guidelines Issued in July

NMPA issued fourteen guidelines in July. The guidelines cover indications of ophthalmic, orthopedic, gastroenterology and urology, anesthesia, and immunology, etc. Full List of Guidelines General Technical review guideline on modification […]
August 13, 2020

Allergan’s Dermal Filler Began RWD Pilot in China

The unapproved devices can be clinically used in Hainan to collect real world data (RWD) and support its regulatory approval from NMPA. Under the policy, the scale-up usage and clinical […]
August 12, 2020

Two Devices Obtain Fast-Track Status in July

NMPA granted Fast-Track Status to two medical device manufacturers in July: Innovation approval status: Clinical Chemistry Shenzhen Guiji Chuangan: continuous glucose monitor Priority review status: Radiology Mingfeng Medical: X-ray computerized […]
August 11, 2020

More Class II & III Medical Devices and IVDs to be Exempted from Clinical Trial

NMPA published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 29, 2020 for feedback. It is an effort to implement risk-based clinical evaluation, and to […]
August 6, 2020

NMPA approved BRAF mutation detection kits

Oncology biomarker testing, as an important tool to guide the treatment of targeted therapy, has been one of the hottest areas for IVD manufactures world-wide. BRAF gene mutations are one […]