Blog

September 13, 2017

CFDA Released 8 Medical Device Industry Standards and a Modification, Including the “Intravascular Catheter and Disposable Sterile Catheter, Part 1: General Requirements”

CFDA Release Recently, CFDA released 8 medical device industry standards and a modification including the “Intravascular Catheter and Disposable Sterile Catheter, Part 1: General requirements” and YY 0669-2008, the first […]
September 11, 2017

CFDA Update: iCAD’s Xoft Axxent Balloon Applicators Approved for Early-Stage Breast Cancer

CFDA UPDATE CFDA Update: CFDA has approved iCAD Inc.’s Xoft Axxent balloon applicators for the treatment of early-stage breast cancer. This approval makes the complete suite of Xoft System products […]
September 8, 2017

This Brand New Tekni-Plex Facility in China Starts Production to Meet Rising demand from Asia’s Medical Device Markets

Tekni-Plex Facility This brand-new factory in Suzhou, China belonging to Tekni-Plex, a US-based packaging company, recently opened it door for business. It is now producing tubing and other custom compounds […]
September 7, 2017

CFDA Released 4 Industry Standards for Medical Devices

CFDA recently issued the No. 99 Announcement of 2017, which issued YY / T 1574-2017 “The guide of the alginate gel fixation or microencapsulation of the tissue engineering medical device products” and other […]
September 7, 2017

CFDA announced the new “Medical Device Classification Catalogue”!

On August 31, CFDA announced the new “Medical Device Classification Catalogue”. This new catalogue will be implemented on August 1ST, 2018. The revised medical device classification directory has significant implications for medical […]
September 7, 2017

Our CEO, Grace Fu Palma, Will be Speaking on 2017 RAPS Regulatory Convergence!

China Med Device, LLC Founder and CEO, Grace Fu Palma, will be speaking on CFDA approval and updates at the upcoming 2017 RAPS Regulatory Convergence in DC.  Ms Palma, a […]
September 6, 2017

The 8th China International Medical Device Regulatory Forum (CIMDR) was held in Hangzhou

The 8th China International Medical Device Regulatory Forum was held in Hangzhou in August. Xiao Hong, deputy director general of China Food and Drug Administration, attended the forum and delivered […]
September 1, 2017

CFDA Updates: Notice on “Requirements of Using Chinese Language for the Name, Resident and Production Address of Applicants, Registration Agents and Filers on Import Medical Devices”.

On August 8th, CFDA issued a drafted notice on “Requirements of Using Chinese Language for the Name, Resident and Production Address of Applicants, Registration Agents and Filers on Import Medical Devices”. In this […]
August 30, 2017

A Shanghai JV Is Created To Invest In International Medical Device Companies

A Shanghai JV Is Created To Invest In International Medical Device Companies The Trendlines Group is an Israeli medical technology incubator that focuses on developing and commercializing medical and agricultural […]
August 28, 2017

CFDA’s Approval Of Gilupi’s CellCollector for In-Vivo CTC Isolation Signifies The Importance of Partnership Between International Medical Device Manufacturers and Chinese Local Firms

To enter the Chinese market, partnership forged between international medical device manufacturers and local Chinese firms is on the rise. In such partnership, the medical device companies are working with […]
August 27, 2017

Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 4 of 4)

The Review and Approval of Innovative Medical Devices In 2016, China Food and Drug Administration received a total of 197  applications for  approval of innovative medical devices, organized expert to […]
August 27, 2017

Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 3 of 4)

1. The Review and Approval of Medical Device Registration Applications In 2016, China Food and Drug Administration completed a total of 9336 technical reviews of medical device registration applications. Compared […]