Regulatory Open Forum

Guangdong government released the "Guideline on Registration of Approved Class II Medical Devices Moving into Guangdong Province (Trial)" to encourage medical device and IVD manufacturers to transfer the registration certificates into Guangdong province.

Guangdong MPA will allow the manufacturer to share the previous submission dossier, even the testing report, and use the fast path to finish the technical review in 5 working days in most cases.

Overseas manufacturers of Class II medical devices and IVDs are also encouraged to register the products in Guangdong with reference to the same fast path.

 

Advantages of Registration Transfer and Device Conversion

1. Transfer the registration certificate to Guangdong to enhance the competitiveness of the device in Guangdong market.

As Guangdong being the most populous province with prosperous economy in China, and Guangdong hospitals are giving preference to Guangdong local products during public tenders. Obtaining exposure in the Guangdong market is beneficial for gaining self-competitiveness and product development.

2. Convert the import products into domestic products to be qualified for public tender.

If the main raw materials, key production processes and quality management system of the medical devices remain unchanged, the applicant may use the self-inspection report to show the compliance of its quality management system. If the production conditions of the device remain unchanged, the applicant may also reuse the information submitted when the original registration certificate was obtained. The expedited and simplified pathway will greatly facilitate the localization of these devices.

However, the new Product Technical Requirements and new Product Registration Testing Reports are still required.

 

Highlights in Guideline

• For registration, applicants shall follow the "Medical Device Registration Dossier Requirements and Document Format" and "In Vitro Diagnostic Reagent Registration Dossier Requirements and Document Format".
• For summary data, non-clinical data (excluding registration test reports), and clinical evaluation data, the original dossier can be utilized for the transfer.
• During registration inspection, inspectors will focus on the consistency and traceability of the quality management system regarding the production technology and material, etc.

If you have any challenge to localize your product in Great Bay Area, please email us for a further discussion.

------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
------------------------------

This message was posted by a user wishing to remain anonymous

Hello Grace,
could you leave the link of "Guideline on Registration of Approved Class II Medical Devices Moving into Guangdong Province (Trial)"?

I want to scan with english translation tool. 

Actually the policy of approved foreign MD is not new, and it applies to all provinces.

ths
Original Message:
Sent: 11-Oct-2022 18:27
From: Grace Fu Palma
Subject: China Guangdong Offers Faster Approval for Overseas Medical Devices Conversion to Domestic Product

Guangdong government released the "Guideline on Registration of Approved Class II Medical Devices Moving into Guangdong Province (Trial)" to encourage medical device and IVD manufacturers to transfer the registration certificates into Guangdong province.

Guangdong MPA will allow the manufacturer to share the previous submission dossier, even the testing report, and use the fast path to finish the technical review in 5 working days in most cases.

Overseas manufacturers of Class II medical devices and IVDs are also encouraged to register the products in Guangdong with reference to the same fast path.

 

Advantages of Registration Transfer and Device Conversion

1. Transfer the registration certificate to Guangdong to enhance the competitiveness of the device in Guangdong market.

As Guangdong being the most populous province with prosperous economy in China, and Guangdong hospitals are giving preference to Guangdong local products during public tenders. Obtaining exposure in the Guangdong market is beneficial for gaining self-competitiveness and product development.

2. Convert the import products into domestic products to be qualified for public tender.

If the main raw materials, key production processes and quality management system of the medical devices remain unchanged, the applicant may use the self-inspection report to show the compliance of its quality management system. If the production conditions of the device remain unchanged, the applicant may also reuse the information submitted when the original registration certificate was obtained. The expedited and simplified pathway will greatly facilitate the localization of these devices.

However, the new Product Technical Requirements and new Product Registration Testing Reports are still required.

 

Highlights in Guideline

• For registration, applicants shall follow the "Medical Device Registration Dossier Requirements and Document Format" and "In Vitro Diagnostic Reagent Registration Dossier Requirements and Document Format".
• For summary data, non-clinical data (excluding registration test reports), and clinical evaluation data, the original dossier can be utilized for the transfer.
• During registration inspection, inspectors will focus on the consistency and traceability of the quality management system regarding the production technology and material, etc.

If you have any challenge to localize your product in Great Bay Area, please email us for a further discussion.

------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
------------------------------