What Is FDA Product Code MQG?
Accessory, Assisted Reproduction is FDA product code MQG, Class 2, 21 CFR 884.6120.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 3 clearances under this code; the FDA took a median of 258 days from receipt to decision on them.
What Has Gone Wrong With It?
The FDA has recorded 9 recalls under this product code since 2018. None was by a company in China. The root causes the FDA records most often are Device Design (4) and Nonconforming Material/Component (2).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.