China Supporting Hong Kong And Macao Medical Device Registrants To Produce Medical Devices In 9 Cities Of The Greater Bay Area

To promote the reform of the medical device registrant system (Market Authorization Holder, MAH for short) in the Guangdong – Hong Kong – Macao Greater Bay Area, Implementation Plan of Supporting Hong Kong And Macao Medical Device Registrants To Produce Medical Devices In 9 Cities of The Greater Bay Area was issued on June 29, 2022.
The Greater Bay Area – with a total population of approximately 78 million people – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen, Zhuhai, Foshan, Dongguan, Zhongshan, Jiangmen, Huizhou, and Zhaoqing.

Scope of application:

• Product scope: Applicable to the medical devices that are held and produced by enterprises legally registered in Hong Kong Special Administrative Region or Macao Special Administrative Region and have been registered for market in China with the Medical Device Registration Certificate.
• Applicable enterprises: If the medical device registrant is a Hong Kong or Macao enterprise, the legal person of a foreign-invested enterprise established in the Greater Bay Area shall act as an agent to handle the registration of medical device changes, assist the Hong Kong and Macao medical device registrants to perform their obligations and assume relevant responsibilities.

Work procedures

• Identify domestic agent;
• Sign the commissioned production agreement;
• Change the manufacturing address of the medical device registration certificate;
• The entrusted production enterprise fulfills its reporting obligations.

BradyKnows elite team has extensive experiences in medical device MAH and localization in China, please contact info@bradyknowsmedical.com for any questions.