Regulatory Open Forum

Many take contract manufacturing as granted since western countries have done this for decades. But it was a different story in China. Companies had to be certificate holders and, at the same time, manufacturers, until January 5, 2018 when Shanghai became the first Market Authorization Holder (MAH) piloting city.

Later Tianjin and Guangdong were added to the trial list published by the China State Council last year.

And on August 1, 2019, additional 18 provinces, including booming markets of Beijing, Zhejiang, Jiangsu and Shandong, were added to the system.

The 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.

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.

The document published on Aug 1 also clarified responsibilities for MAH and Contract Manufacturer:

MAH:

1. Legally responsible for product design, clinical trial, manufacturing, sales and post-sales, recall and adverse event reporting, etc;
2. Sign Letter of Authorization and Quality Agreement with contract manufacturer(s), and clarify both responsibilities in Product Technical Requirement (PTR), quality assurance and dischargement;
3. Conduct periodical GMP audit for conduct manufacturers;
4. Ensure device traceability and conduct adverse event monitoring;
5. Ensure data authenticity in clinical trial or clinical evaluation report (CER)

Contract Manufacturer:

1. Perform obligations specified by "Medical Device Supervision and Administration Regulations", Letter of Authorization and Quality Agreement;
2. Responsible for MAH on device quality;
3. Report quality issues to provincial NMPA where it locates.

 

If you want more info or have any plan to go by China MAH pathway, please leave comments here or email me at gpalma@ChinaMedDevice.com.

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

Have there been significant changes to the MAH rules in China regarding medical device contract manufacturers within the past few years?

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Samuel Brayton
South Glens Falls NY
United States
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Original Message:
Sent: 21-Aug-2019 16:32
From: Grace Fu Palma
Subject: NMPA (CFDA): MAH Available in 21 Provinces, Green-Lighting Contract Manufacturing

Many take contract manufacturing as granted since western countries have done this for decades. But it was a different story in China. Companies had to be certificate holders and, at the same time, manufacturers, until January 5, 2018 when Shanghai became the first Market Authorization Holder (MAH) piloting city.

Later Tianjin and Guangdong were added to the trial list published by the China State Council last year.

And on August 1, 2019, additional 18 provinces, including booming markets of Beijing, Zhejiang, Jiangsu and Shandong, were added to the system.

The 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.

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.

The document published on Aug 1 also clarified responsibilities for MAH and Contract Manufacturer:

MAH:

1. Legally responsible for product design, clinical trial, manufacturing, sales and post-sales, recall and adverse event reporting, etc;
2. Sign Letter of Authorization and Quality Agreement with contract manufacturer(s), and clarify both responsibilities in Product Technical Requirement (PTR), quality assurance and dischargement;
3. Conduct periodical GMP audit for conduct manufacturers;
4. Ensure device traceability and conduct adverse event monitoring;
5. Ensure data authenticity in clinical trial or clinical evaluation report (CER)

Contract Manufacturer:

1. Perform obligations specified by "Medical Device Supervision and Administration Regulations", Letter of Authorization and Quality Agreement;
2. Responsible for MAH on device quality;
3. Report quality issues to provincial NMPA where it locates.

 

If you want more info or have any plan to go by China MAH pathway, please leave comments here or email me at gpalma@ChinaMedDevice.com.

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