In order to further promote the full implementation of the production quality management standards of medical devices and set up the exemplary role of normative enterprises, the on-site promotion work of the production quality management standards of medical devices of the whole province was held in Hangzhou a few days ago.Su Zhiliang, chief engineer of the provincial bureau, responsible person of the equipment department of the provincial bureau, responsible person of the medical device supervision department of the municipal bureau, and responsible person of the medical device supervision of hangzhou district, county (city) attended the promotion meeting.
At the propulsion ShengJu notified by the provincial medical equipment production and the quality control standard for demonstration enterprises create conditions and five specifications, city bureau of hangzhou, wenzhou city bureau respectively for the exchange of experience in promoting meeting, introduced a second class of equipment manufacturing enterprises and the quality control standard for advancing the implementation of other city bureau to report the standard measures to promote the progress and future work within their respective jurisdictions.After that, the provincial and municipal medical device supervisors visited a second-class medical device manufacturer -- Zhejiang Ganevi Medical Technology Co., LTD., and investigated its quality system guarantee operation.
Chief Engineer Su Zhiliang affirmed the current progress of the implementation of local standards, and stressed that the full implementation of GMP in medical device manufacturers from January 1, 2018 is an important requirement for the General Administration of China to comprehensively promote the assurance of medical device quality system and promote supervision, and local regulatory authorities pay close attention to on-site inspection.He once again stressed that although the task of standardized verification is heavy and intensive this year, all regulatory authorities cannot relax the verification standards. In particular, a class of production enterprises should also be implemented in accordance with the requirements of the standards. The rectification should be carried out and the suspension of production should be suspended.