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

CFDA Monthly Roundup (September)

Monthly CFDA News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (, […]
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 […]