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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.

The series

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?

The series

On New Medical Device Regulations in China

On Clinical Evaluation and Clinical Trials

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.

The series

On New Medical Device Regulations in China

On the Medical Device Registrant System in China

On Online Sales of Medical Devices in China

On 18 March 2021, the State Council promulgated the Regulations on Supervision and Administration of Medical Devices, which will take effect on 1^st June 1st, 2021 (the “2021 Regulations”).

Compared with the existing Regulations on Supervision and Administration of Medical Devices (lastly revised in 2017), the 2021 Regulations focuses more on innovation and development of the medical device industry, as well as quality and safety of medical device products.

We briefly summarize the amendments brought by the 2021 Regulations in this newsletter.

This newsletter is the first newsletter of our serie 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

The series

Medical Devices – Clinical Evaluation and Clinical
Trials

On the Medical Device Registrant System in China

On Online Sales of Medical Devices in China