The NMPA published “Implementation Plan for Supporting Hong Kong and Macao Drug Market Authorization Holders to Produce Drugs and Medical Devices in 9 Mainland Cities in the Greater Bay Area (GBA)” today, June 29, 2022. The document is to facilitate the urgent use policy in GBA in the manufacturing phase.
Urgent Use Policy
The Greater Bay Area – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen, Zhuhai, Foshan, Dongguan, Zhongshan, Jiangmen, Huizhou, and Zhaoqing. These nine cities are applicable of urgent use policy for medical devices and drugs starting in May 2021.
While not-yet-approved in the mainland, Hong Kong or Macao approved drugs and medical devices can be utilized in GBA. They can be used only if the significant clinical benefits with urgent needs can be demonstrated. Guangdong provincial NMPA will decide on import approval within 20 working days.
Market Authorization Holder GBA
The Market Authorization Holder GBA (MAH) system has major implications for the developers who have limited manufacturing capabilities. Companies that register devices do not have to be the manufacturers. They may commission one or multiple qualified contract manufacturing organization(s) to manufacture the approved medical devices.
On 5 January 2018, Shanghai became the first MAH piloting city. Later 18 provinces were added to the trial list published by the China State Council in 2019.
The MAH system helps incentivize the medical device developers to focus on research and development, and it accelerates the marketing process of the device. The first device approved though the system was the portable ECG recorder. It only took 26 working days from filing acceptance to final approval.
Responsibilities of MAH and contract manufacturers
The document also clarified responsibilities for foreign MAH and its designated contract manufacturers:
- Has device which was by in Hong Kong or Macau authority, and China NMPA
- Legally responsible for product design, clinical trial, manufacturing, sales and post-sales, recall and adverse event reporting, etc
- Apply medical device change registration before authorizing contract manufacturers
- The main raw materials, production processes and the quality management system should be kept unchanged when manufacturing in GBA
- Sign the contract production agreement. With reference to the “Guideline for Quality Agreements on Entrusted Production of Medical Devices” formulated by the NMPA, Hong Kong and Macao medical device registrants, agents and contract manufacturers jointly sign quality agreements and entrustment agreement
- Conduct periodical GMP audit for conduct manufacturers
- Ensure device traceability and conduct adverse event monitoring
- Perform obligations specified by “Medical Device Supervision and Administration Regulations” and Letter of Authorization and Quality Agreement
- Responsible for MAH on device quality
- Report quality issues to provincial NMPA where it is located.
For an English copy of the GBA MAH document with the application flow chart, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.