Isabelle Doyon's legal and international news

Since the enactment of the Personal Information Protection Law (PIPL), enterprises anticipate that this new law may provide a solution to legitimize the cross-border transfer of personal information.

According to item 2 of Article 38 of the PIPL, when a controller needs to transfer personal information outside of China, it may choose to obtain an personal information protection certification issued by a professional institution in accordance with the relevant requirements set by the Cyberspace Administration of China.

Who are the relevant service providers in China? If so, are they qualified to meet Article 38 of the PIPL as personal data protection certification service providers? What is the scope of this draft standard and what are its requirements?

According to Zhang Beibei and Isabelle Doyon from our Shanghai office, a draft national standard released in late April 2022 provides some guidance.

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

Web crawlers (web spiders, web robots) are programs or scripts that automatically browse a website, grab information and build an index.

In our Data Economy, web crawlers permit companies to obtain and exploit large volumes of data which, once analyzed, can have a significant impact on their productivity and profitability.

The question is: Can web crawlers freely crawl any type of data from any website?

In this edition of our China newsletter, Zhang Beibei and Isabelle Doyon offer provide answers on the technical and legal limitations to the use of web crawlers.