On May 26th, UL’s Health Sciences division and engineers from The Shanghai Testing & Inspection Institute for Medical Device (CMTC) are teaming up to present an industry opportunity to learn more about cFDA regulations and testing. The seminar topics will focus on the introduction of new cFDA regulations, cFDA registration testing & key points, preparing a product’s technical requirements file, the execution of IEC 60601-1 3rd edition in China, as well as, the CMTC testing process.
In addition to the morning seminar, attendees will also have the chance to register for a 1:1 meeting with one of the two engineers to discuss specific product related questions. Space is limited and is filled on a first come, first served basis.
See below for additional event details.
Event Date & Time
Tuesday, May 26th
Seminar Presentations: 10 am- 3 pm
1:1 Reserved Meetings: 3 pm- 5 pm (30 minute sessions, 1 per company)
UL Northbrook Campus- Main Building 6 - Mezzanine Room
333 Pfingsten Rd.
Northbrook, IL 60062
Seminar Registration fee: $50 before May 19th, $75 after May 19th (Additional registrations will receive a $10 discount.)
1:1 Meeting Fee: $50
10:00 – 10:05 – Introductions
10:05- 10:45 - Introduction of cFDA registration testing and key points need notice such as critical component requirement, et al
10:45 – 11:30 - Brief introduction of cFDA new regulation
11:30 – 12:15 - How to prepare product technical requirements file before cFDA registration testing? (Product technical requirements file includes detailed product information, applicable standard, test method and criteria, CMTC will base on it to perform test. Product technical requirements file is required in new cFDA regulation which was executed in June 1, 2014)
12:15 – 1:00 - Lunch
1:00 – 1:45 - Updated information of the execution of IEC60601-1 3rd edition in China
1:45 – 2:30 - CMTC testing process
2:30 – 2:55 - Public Q&A
2:55 – 3:00 – Closing remarks and instructions
3:00- 5:00- Scheduled 1:1 Meetings
Mr. Liu Jiong, Ph.D. Senior testing engineer of CMTC with over nine years’ experience of cFDA testing, familiar with imaging products such as X-ray, CT, MRI etc. He has expert knowledge of GB&IEC standards for medical devices, risk analysis and risk management procedures, statistical methods, and has expertise in analyzing the uncertainty of measurement.
Mr. Tao Kan, Senior testing engineer of CMTC with over six years’ experience of cFDA testing, is familiar with ultrasound devices, patient monitors etc. Mr. Kan’s expertise is in GB, IEC, YY standards for medical devices, cFDA regulations and ISO 17025. He has performed cFDA testing for GE, Siemens, Philips and Toshiba products.