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DuPont China plays key role in regulatory activities

The medical packaging industry has been getting increased attention from regulatory bodies in China, with new standards being adopted to promote the safety and efficacy of medical devices. 

In 2005, ISO 11607:20003 was adopted as GB/T 19633:2005. The final draft of the revision of GB/T 19633, which is adopted from ISO 11607:2006, has been submitted to the local regulatory body for final approval. In addition, 13 ASTM test methods have been adopted as local industry standards to support the implementation of GB/T 19633 (ISO 11607).

The Center for Medical Device Evaluation of the Chinese State Food and Drug Administration (SFDA) has issued a guidance principle requesting that local medical device manufacturers (MDMs) provide evidence of compliance with GB/T 19633 or ISO 11607 when submitting a medical device for registration. 

To help MDMs in adopting and adhering to these new standards, a medical packaging working group was formed in March 2012 by the Medical Macromolecular Product Branch of the China Association for Medical Device Industry (CAMDI).

DuPont China was named as deputy leader of this new medical packaging working group because of its demonstrated leadership and expertise in the medical packaging industry. Park J. Qian, regulatory and standard advocacy competency manager, DuPont Protection Technologies China, and Selena Qin, senior technical marketing specialist, DuPont Medical and Pharmaceutical Protection Asia Pacific, will represent DuPont China in this working group.

Qian, who joined DuPont in 1995, is a member of the China National Standards Technical Committee of Infusion Equipment for Medical Use. He earned a master’s degree in material science and technology from China Textile University. He had been working as a lecturer of the university for 5 years prior to joining DuPont.

Qin joined DuPont in 2011 with 17 years of experience in medical industry. She graduated from Fourth Military Medical University and had practiced medicine as a radiologist and a surgeon for seven years. She holds a MBA from Xi`an Jiaotong University in 2002 and worked for two global MDMs in product and business management prior to joining DuPont.