Medical Polymer Products Branch of CAMDI held GB8368-2018 Standard Publicity, Implementation & Training Meeting in Changzhou, Jiangsu Province

  • 2018-10-09
The GB 8368-2018 Infusion Sets for Single Use — Gravity feed Publicity, Implementation & Training Meeting was held by Medical Polymer Products Branch of CAMDI in Changzhou, Jiangsu on September 21, 2018.

Ms. Li Weiyang (the secretary-general), Mr. Zhang Honghui (the general adviser), Mr. Xu Yanruo (the division head & expert), representatives of regulation group of the Branch, Mr. Wan Min and Mr. Yao Xiujun (directors of Shandong Quality Inspection Center for Medical Device), and nearly 160 enterprise representatives attended the meeting.

The meeting was presided over by the secretary-general Li Weiyang. Ms. Li described the preparation and release of GB 8368-2018 Infusion sets for single use — Gravity feed. She highlighted that the purpose of the meeting is to offer profound interpretation of the new standard to make it clearer to the participants, and help enterprises tackle difficulties encountered in the implementation of the new standard.

Mr. Wan Min, the director of Physical Office, Shandong Quality Inspection Center for Medical Device, shed light on the GB 8368-2018 standard. He also explained the technical focuses and difficulties of injection parts, packages, and detection concerns, and the standard implementation guideline. Later, Mr. Wan and Mr. Yao answered the questions put forwarded by enterprise representatives on the spot.

Mr. Su Weidong, the deputy secretary general of the Branch and vice director of the regulation group, on behalf of the regulation group, communicated and shared with the participants the measures and suggestions on responding to the implementation of GB 8368-2018 standard. He briefed the foundation, number of members and main task of the regulation group of the Medical Polymer Products Branch. And then he compared the new standard with the old one on the 12 changed articles, and analyzed the impact of the change on enterprises concerning registration, system, equipment and marketing, and gave some workable suggestions.

At the end of the meeting, Mr. Zhang Honghui (general adviser of the Branch), Mr. Xu Yanruo (division head & expert), Mr. Gao Yicen (chairman of the Standardized Technology Management Committee of the Branch) and Mr. Su Weidong (vice director of the regulation group) answered the questions posed by the participants, in hoping to help enterprises understand and implement the new standard.

Participants took the meeting seriously and meticulously and considered it a timely and thoughtful publicity and implementation meeting on GB 8368-2018 new infusion sets standard. They believed the meeting will facilitate the implementation of the new standard.