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Zhejiang: focus on the production of third types of medical devices

2015-10-19

Medical network in October 19th, Zhejiang province food and Drug Administration issued the "comprehensive advance medical equipment production quality management standards implementation work plan", which requires that since January 1, 2016 and January 1, 2018, the province's third types of medical equipment manufacturing enterprises and all medical equipment production enterprises must meet the requirements of medical equipment production quality management standards.

"Plan" in:

Efforts to do a good job of the third types of medical equipment manufacturing enterprises, the implementation of the "standard"

Steadily promoting the implementation of the first and two kinds of medical instrument manufacturing enterprises "standard"

Concrete measures:

First, the provincial drug certification inspection center in accordance with the "standard" and the relevant appendix of the requirements, the development of inspection and acceptance criteria, detailed examination of the contents of the unified inspection standards, on-site inspection personnel, corporate legal representative and quality management personnel training

Two enterprises to carry out self-examination

Three is the certification center organization inspector to carry on the spot check

Four is to do a good job in the implementation of the. At the same time, in order to promote the province's medical device industry transformation and upgrading, to enhance the level of encouragement and guidance of enterprises in the implementation of the norms of mergers and acquisitions, bigger and stronger to do business. In accordance with the regulation of medical devices regulations, provincial bureaus will in product registration and licensing of the convergence of the system actively, be supported.

In order to ensure the smooth progress of the work of the implementation of the "standard", the Bureau of Zhejiang Province will strengthen "standard" implementation of the guidance, around the timely resolution of the difficulties and problems encountered in the process of policy and technology advance, progress of work throughout the inspection and supervision, and regular reporting.

Chinese medical devices believe that: the training of personnel should not only be implemented in the oral, should spend more time and energy on the actual combat drills. So that the inspectors in-depth understanding of each link and steps, at the same time to simulate actual combat exercises, so as to achieve the desired results.

Medical network in October 19th, Zhejiang province food and Drug Administration issued the "comprehensive advance medical equipment production quality management standards implementation work plan", which requires that since January 1, 2016 and January 1, 2018, the province's third types of medical equipment manufacturing enterprises and all medical equipment production enterprises must meet the requirements of medical equipment production quality management standards.

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