Contract manufacturing of Hong Kong & Macao medical devices and drugs in the Greater Bay Area (GBA) is now supported by the China NMPA (National Medical Products Administration) following its implementation plan announced on June 29, 2022. The implementation plan supports Hong Kong and Macao medical device and drug market authorization holders (MAHs) to entrust cross-border production in the 9 cities of the Greater Bay Area, which includes Guangzhou, Shenzhen, Zhuhai, Foshan, Huizhou, Dongguan, Zhongshan, Jiangmen and Zhaoqing.
Scope of Application
The plan is applicable to proprietary Chinese medicines, chemical drugs and medical devices that fulfill the following conditions:
| Scope |
| Drug |
Medical Device |
- Produced by legally registered Hong Kong or Macao enterprises
|
- Obtained the respective local market approval in Hong Kong or Macao
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- Obtained the "Drug Registration Certificate" from the China NMPA
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- Obtained the "Medical Device Registration Certificate" from the China NMPA.
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- The drug contract manufacturers should be a pharmaceutical manufacturer with the registered address and production site in one of the 9 GBA cities, and have obtained the "Drug Production License", as well as meeting the required production scope or compliant to GMP inspection.
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- The medical device contract manufacturers should be a medical device manufacturer with the registered address and production site in one of the 9 GBA cities, and its quality management system and production capacity should be compatible with the Hong Kong or Macao enterprise.
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Steps to contract manufacturing of Hong Kong/Macao medical device and drug in GBA
| Application Steps |
| # |
Drug |
Medical Device |
|
1
|
- The Hong Kong/Macao MAH shall designate a legal entity from the 9 GBA cities as the domestic agent
|
|
2
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- The Hong Kong/Macao MAH and the contract manufacturers shall sign the quality agreements and entrustment agreements
|
|
3
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- The drug contract manufacturers shall submit the application to the Guangdong MPA (Medical Products Administration) to add the Hong Kong/Macao MAH's entrusted production to their "Drug Production License"
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- The domestic agent shall assist the Hong Kong/Macao MAH in submitting the application to NMPA for changing the manufacturing address in the medical device registration certificate
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4
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- The Hong Kong/Macao shall submit the application to the NMPA to add the manufacturing site for domestic drug production
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- The medical device contract manufacturers shall report to the Guangdong MPA and submit information related to the entrusted production including the name of the Hong Kong/Macao MAH, product information, contract duration, etc.
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Responsibilities of MAH, domestic agent and contract manufacturers for drugs
- The Hong Kong / Macao MAH shall ensure the quality management of the entire product life cycle is well established, and the obligations for drug traceability, pharmacovigilance, annual reports, etc. are performed.
- The Hong Kong / Macao MAH shall supervise the contract manufacturers to ensure the obligations stipulated in the quality agreement and the entrustment agreement are being fulfilled.
- The contract manufacturer shall ensure the production process, quality standards and GMP is in strict accordance with the registration approval requirements, and must keep all documents and records.
- The domestic agent shall perform the obligations of the MAH and bear joint liability with the MAH
Responsibilities of MAH, domestic agent and contract manufacturers for medical devices
- The Hong Kong / Macao MAH shall ensure the quality management of the entire product life cycle is well established, and the obligations for adverse event monitoring and product recall, etc. are performed.
- The Hong Kong / Macao MAH shall supervise the contract manufacturers to ensure the obligations stipulated in the quality agreement and the entrustment agreement are being fulfilled.
- The domestic agents shall bear joint liability whilst assisting Hong Kong / Macao MAH in fulfilling their registrant obligations.
- If the production and business operation in the 9 GBA cities violates the Supervision and Administration of Medical Devices or other related regulations in China, the Hong Kong / Macao MAH shall bear the main responsibility whilst domestic agents bear joint liability and contract manufacturers bear the corresponding legal responsibility.
Victoria Caldy
Business Development & Marketing Director
Cisemavictoria.caldy@cisema.com