Blog

October 29, 2018

Rare Disease Device Guideline: Imported Device Exempt from Clinical Trial If Meeting Certain Requirements

CFDA issued Registration Guideline on Medical Device for Rare Disease on October 18th, 2018 in an effort to address the huge unmet medical needs. The guideline lists three situations when […]
October 26, 2018

NMPA (CFDA) Monthly Roundup (September)

October 24, 2018

AstraZeneca and 5 Others Caught for Violating China’s Human Genetic Regulation: Clinical Data Rejected

The Ministry of Science and Technology of China imposed penalties today (Oct 24th) on 6 companies for violating regulations on human genetic resources. AstraZeneca and 5 domestic companies are on […]
October 16, 2018

Grace Palma to Present on ASQ and RAPS Boston

Wednesday, 24 October 2018 3:00-7:00 pm EST The Conference Center at Waltham Woods 860 Winter Street Waltham, MA 02451   Don’t miss this unique opportunity to engage with regulatory and […]
October 16, 2018

CFDA: Record Number of Guidelines and Standards Issued in September

In the month of September, unprecedented number of medical device guidelines and industry standards issued by CFDA to expedite your registration and renewal.   Guideline CFDA issued 12 Technical Review […]
October 14, 2018

Siemens, Medtronic Found Incompliance in CFDA Clinical Audit

For the first time in 2018, NMPA (formerly CFDA) issued clinical trial incompliant companies report.  In this Medical Device Clinical Audit Notice on September 12th, Siemens and Medtronic, along with […]
October 8, 2018

Thank You for Visiting Us at RAPS!

Thanks for taking the time to visit China Med Device at the RAPS Convergence in Vancouver.  I appreciate the opportunity to share some of the latest developments at NMPA (CFDA) […]
October 4, 2018

Price of consumables fell by more than 80% in China

The price of high-value medical consumables is relatively high. These consumables are usually used for special treatments like cardiac intervention therapy, peripheral vascular intervention, artificial joints replacement, and other organ […]
October 1, 2018

Faster and Lower-Cost Entry into China: CFDA New Clinical Exemption Catalog Issued

NPMA (formerly CFDA) published the “Clinical Exemption Catalog for Medical Devices” yesterday (Sep 30th), in which a total of 855 medical devices and 393 IVDs exempted from clinical trial. It […]
September 27, 2018

China Med Device Exhibits at RAPS Annual Conference

Visit China Med Device at RAPS October 1 – 4th in Vancouver and Get the Latest Update on NMPA (formerly CFDA) and a Glamor Shot! China Med Device, LLC is […]
September 26, 2018

China Med Device, LLC Won Contract with China Telecommunication Giant

NORTH ANDOVER, Mass. – July 27, 2018 – China Med Device, LLC (CMD), a leader in helping medical technology companies enter the Chinese marketplace, received the contract to guide China […]
September 21, 2018

New Trends in Medical Artificial Intelligence – Part 2

Disease Risk Management A hot application scenario of medical artificial intelligence is disease risk management. When applies to a specific disease treatment area, AI can improve the diagnosis accuracy and […]