Not authorized to the unqualified factory processing production, you ask this question, specifically to ask the business administration department will be more secure.
Based on the supervision and management of medical devices regulations, no medical device licensing business license and production, management of medical devices without obtaining a medical device registration certificate of the second class, the third class of medical devices, or engaged in the production of the second class, the third class of medical devices, or engaged in the operation of the third class of medical devices, or not licensed to engage in the operation of medical devices, the supervision and management of the department of the drug administration may be subject to administrative penalties. For the illegal medical device business enterprise, the possible administrative responsibilities include: confiscation of illegal income; confiscation of production and operation tools, equipment, materials, instruments and other items; if the amount of goods is less than 10,000 yuan, and at the same time impose a fine of 50,000 yuan or more than 150,000 yuan. If the amount of goods is more than 10,000 yuan, a fine of more than 15 times the amount of goods and less than 30 times the amount of goods shall be imposed at the same time; and the production shall be suspended and the license cannot be reapplied for 10 years. For the main responsible personnel of the offending unit includes the following penalties: confiscation of illegal income; impose a fine of more than 30% of the income of more than three times the following fine; in the relevant industry sectors of the lifelong ban on the practice.