国产一区二区精品传媒,DAY6麻豆传媒映画现,爱豆传媒赵一曼作品大全

首頁 // 目標(biāo)市場(chǎng) // 中國(guó)市場(chǎng) // Medical Devices // The administration and regulation of medical devices

美國(guó)市場(chǎng)

歐盟市場(chǎng)

中國(guó)市場(chǎng)

香港市場(chǎng)

日本市場(chǎng)

Certificate of new medical devices and clinical trails

時(shí)間: 2020-10-21

New medical devices refer to the kind of brand new product varieties which have not been available in the domestic market, or for which the safety, effectiveness and product mechanism have not been recognized domestically.

New medical devices that have completed clinical trials and passed experts evaluation and review organized by SFDA under State Council, shall receive a new product certificate after being approved by the same organization. Clinical trial or verification shall be conducted in the medical institutions designated by the drug regulatory authorities of the government at provincial level and above. The qualification of medical institutions engaged in the clinical trial or verification shall be certified by the drug regulatory authority, jointly with the health authority under the State Council.

l Class II and Class III medical devices:

Clinical evaluation must be conducted before they are put into production. The regulatory authorities of provinces, autonomous regions and municipalities directly under the central government are responsible for the inspection and approval of the clinical trial or verification of class II medical devices in their own administrative regions, while the SFDA is responsible for the inspection and approval of clinical trial or verification of class III medical devices.

l Class I medical devices:

Class I products are exempt from clinical trails.

For more information please contact 86-755-83997910 or email to wrr@sist.gov.cn