What is QSR820?

It is 21CFR PART 820, i.e. the FDA’s QUALITY SYSTEM REGULATION - (QSR820), in which the requirements of the US for the current quality management standards of medical devices (CGMP) are described.

What enterprises need to establish the QSR820 system?

The Class I, Class II and Class III medical devices sold to the US need to have a quality management system established that meets the requirements of QSR820.

When should the QSR820 system be established?

It can be established when the product is registered or listed.

What is the necessity of establishing the system?

As the FDA’s supervision becomes more and more strict, the chance that China’s medical device enterprises registered with the FDA are spot-checked will be increasingly higher. If the factory inspection fails, your enterprise will be drawn into a “blacklist” or be issued a “warning letter”. As a result, your enterprise will not be able to deliver goods normally. Therefore, it is necessary to establish a system that meets the requirements of QSR820 after the medical device is registered or listed with the FDA.

As a global technical service provider that is professional in the field of medical device regulations, SUNGO can provide the following services:

1.  Establish a quality management system that meets the requirements of 21 CFR part 820, protect you from mistakes, and reduce the risk of being issued a warning letter or being drawn into a “blacklist”

2.  Perform the difference analysis to find the differences between your enterprise and QSR820

3.  Provide the suggestions for improvement

4.  Simulate the audit, and train the ability to respond to the audit

5.  Provide the targeted training to help the enterprise improve continuously


SUNGO service process


Specific task

Division of work



Establishing and improving the system that meets QSR820

Both parties

2-4 weeks


Identifying the differences between the enterprise’s current system and QSR 820 and proposing the rectification suggestions

Both parties

2-4 weeks


Inspecting the rectification of the differences

Both parties

2-4 weeks


Training the ability to respond to the audit

Both parties

About 2 weeks


Providing the targeted training

Both parties

About 2 weeks