DS China Newsletter
Fourth (and final) newsletter of our series dedicated to Medical Devices Regulation in China further to the promulgation of the Regulations on Supervision and Administration of Medical Devices, which entered into force on June 1st, 2021.
In this newsletter we focus on online sales of MDs and see what the regulatory requirements under the 2021 Regulation are.
Indeed, the on-line distribution model of MD (“Internet plus MD”) developed under the impact of Covid-19; therefore, it is crucial for companies involved in the business operations of MD to master the regulatory framework of online sales.
On New Medical Device Regulations in China
On Clinical Evaluation and Clinical Trials
On the Medical Device Registrant System in China
Third newsletter of our series dedicated to Medical Devices Regulation in China further to the promulgation of the Regulations on Supervision and Administration of Medical Devices, which entered into force on June 1st, 2021.
We have previously looked at the broad outlines of the 2021 Regulation, before detailing the provisions on clinical evaluation and clinical trials.
In this newsletter we will focus on the new registration system for Medical Devices (“MD”).
The introduction of the MD Registrant System in China is one of the key point of the 2021 Regulation. This corresponds to the concept of “marketing authorization holder” for pharmaceuticals.
What is the MD Registrant System? How does it work? What are the impacts of this new system for MD supervisions?
On Online Sales of Medical Devices in China
Second newsletter of our series dedicated to Medical Devices Regulation in China further to the promulgation of the Regulations on Supervision and Administration of Medical Devices, which entered into force on June 1st, 2021.
In this newsletter we will take a closer look at clinical evaluation and clinical trials.
The 2021 Regulations encourages, through different measures, innovation and development of the medical device industry, Chinese regulators intending to maintain the delicate balance between safety and innovation in this area. The rules related to clinical evaluation and clinical trial for medical devices are in this framework.
Les Brèves by DS Avocats
[Corporate Law] –
Following a decree promulgated on December 28th, 2020, the State Council issued a revised regulation on registering business names (the “Provisions”). These Provisions have come into effect on March 1st, 2021, with the purpose of standardizing business name registration, protecting the legitimate rights and interests of enterprises, maintaining social and economic order, and improving the business environment.
Xu Sissi and Isabel Moga Rella provide the highlights of these Provisions.
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