Which is more strictly regulated, medical devices or otc drugs?

Both are very strict.

Medical devices are more difficult to regulate than drugs, the market is chaotic, and the threshold of entry for class I and II devices is low.

Laws and regulations are not sound, there are many loopholes, and there is no GMP, GSP similar to drugs.

China's OTC drugs are direct consumer-oriented, consumer-centered, consumers buy on their own, do not need to go through a doctor, and show more characteristics of general consumer goods than prescription drugs, and are more responsive to consumer wishes and needs, thus the market has a very large potential.