Class II medical device sales need medical device registration certificate?

If you are a manufacturer, then the production and sale of Class II devices need to go to the provincial Food and Drug Administration to register, obtain product registration certificate before production and sales.

If you are purchasing from a manufacturer, then you can ask the manufacturer for the product registration certificate, while your company needs to have the "Class II Medical Device Business Record Certificate" in order to sell. The "Class II Medical Device Business Record Certificate" can go to the municipal Drug Administration where your company is located to apply for

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