Regulation

Regulation

Regulation

Regulation with CFDA

Of course, for the first step of penetration into the Chinese Medical market required a CFDA certificate. This step can be tiring and not profitable for the company, in the regular way it can take 5 years! But with us you can save time and costs ; 1 – 2.5 years We will commit to the success of the process, otherwise we will refund your payment.

SinoSciences, especially its professional medical’s team and regulator’s team will register your company through a special process in the treatment department in a special Province – For your maximal comfort, managed by our local office in this strategic area that’s authorized to facilitate the issuance of the necessary permits. 

On condition for this process is a health certificate from a development country  (FDA / CE / Israeli health certificate / Japanese health certificate etc.). – If you are under the certificate process we can communicate and find a way to cooperate. We will also apply to the pilot zone’s local administration and continue submitting the provincial health administration’s approval. 

With us, foreign companies can leverage the new policies to establish a commercial site in China and expedite the China NMPA registration process, based on the Real-Life Big Data approach that’ll reduce great resources and valuable time.

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The general process that will lead by SinoSciences LTD

Province FDA approve
The importation gets approval from the Province Health Commission and Province FDA.
Import application
The treatment department of your field in a unique hospital applies to the Province Health Commission and Province FDA to import your medical product.
Commercial usage
The treatment department of your field in "Dedicated Hospital" will use your product on patients. It is a commercial usage within the unique area. However, mostly it is still in clinical tests to get more test data.
Real Life DB
The clinic data will be uploaded to the pilot zone database, which is connected to the China Health Commission and China FDA (NMPA system). With enough clinical cases and data, the provincial health administration will report to NMPA and request for evaluation.
NMPA / CFDA Certificate
Your product passes CFDA evaluation and gets a CFDA importation certificate.
Distribution Process
YOUR TECHNOLOGY WILL BE SOLD IN THE WHOLE OF CHINA. THE ACTUAL PERIOD CAN BE 1 - 2 YEARS. MOREOVER, DURING THIS YEAR, IT IS POSSIBLE TO START SELLING THE PRODUCT.

Advantages

1-2.5 years compare 5 years in regular way

Holding FDA / CE / AMAR etc.

Refund of unsuccessful process

Clinic trials to Real life big data

Pilot zone

Let`s Start

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