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Shu Guang Jian Shi

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The FDA will issue a new medical device regulatory policy for medical device units or benefit.

The FDA will issue a new medical device regulatory policy for medical device units or benefit.

The Shanghai Securities News reported that the reporter learned from the current State Food and Drug Administration yesterday that the drug administration will soon introduce two new medical device supervision policies, which will guide the registration of innovative medical device products and further simplify the re-registration requirements for medical devices. Industry insiders said that the introduction of relevant measures will help promote the merger and integration of the medical device industry and benefit the development of innovative medical device enterprises.

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The future medical device consumer market will further expand

The future medical device consumer market will further expand

Of the medical instruments and equipment owned by 175000 medical and health institutions across the country, about 15% were products around the 1970 s and 60% were products before the mid-1980s. This also indicates that they need to be updated, and in this process, it will ensure the rapid growth of China's medical device market in the next 10 years or even longer.

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Regulation on the Supervision and Administration of Medical Devices (Order No. 276 of the State Council)

Regulation on the Supervision and Administration of Medical Devices (Order No. 276 of the State Council)

Article 1 In order to strengthen the supervision and management of medical devices, ensure the effectiveness of medical devices, and protect human health and life, these regulations are formulated. Article 2 Units or individuals engaged in the development, production, operation, use, supervision and management of medical devices within the territory of the People's Republic of China shall abide by these regulations.

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Measures for the Supervision and Administration of Disposable Sterile Medical Devices (Provisional) (Bureau Order No. 24)

Measures for the Supervision and Administration of Disposable Sterile Medical Devices (Provisional) (Bureau Order No. 24)

Measures for the Supervision and Administration of Disposable Sterile Medical Devices (Provisional) (Bureau Order No. 24)

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Shu Guang Jian Shi

Measures for the Supervision and Administration of Medical Device Production (Order No. 12 of the Bureau)

Measures for the Supervision and Administration of Medical Device Production (Order No. 12 of the Bureau)

Measures for the Supervision and Administration of Medical Device Production (Order No. 12 of the Bureau)

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Notice on Issuing the Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices (for Trial Implementation)

Notice on Issuing the Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices (for Trial Implementation)

Notice on Issuing the Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices (for Trial Implementation)

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Shu Guang Jian Shi