How to Apply for Measurement

I, the reporting conditions of the mechanical name:

medical device production sites, qualified samples, mature formulas, perfect plant and equipment

Second, the process of the declaration of the consumer name

signing the contract - to confirm the formula - to provide the material - to prepare and improve the material - expert review - testing - to prepare the finalized material - on-site review - the Provincial Bureau of the audit

Third, the mechanical name Declaration will encounter problems

1. Classification issues, to confirm whether the category of medical devices, and need to confirm that the first class, the second or third class

2. Declaration of the main body does not meet the declaration of the main body must be a perfect medical device manufacturers

3. Declaration of the material is not standardized, irregularities often exist, but before the formal submission of the issue, this is all by our customs

4. Policy changes, the state will be based on the existing actual situation, adjust the policy, do not have to panic too much, the state in making adjustments, there must be a transition period, has been declared how to deal with the product, is declared how to deal with the product

5. do not have their own brand name that is the trademark, you can synchronize the application, basically does not affect the declaration

Fourth, whether the cream can apply for a medical device number

The answer is certainly not, plasters generally contain Chinese medicine ingredients, and medical devices are instrument products, medical devices are directly or indirectly used for the human body instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items, including the need for computer software.

Efficacy is obtained primarily by physical means, not by pharmacologic, immunologic, or metabolic means, or when these means are involved but only in an ancillary manner.

The purpose is the diagnosis, prevention, monitoring, treatment, or mitigation of disease; the diagnosis, monitoring, treatment, mitigation, or compensation of injury; the examination, replacement, modulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the examination of samples from the human body to provide information for medical or diagnostic purposes.

The combination of the above explanations, ointment is certainly not declare the mechanical name.

The approval number of the drug is: State Drug License (H, Z, B, J, S) 8 digits, divided into prescription drugs and non-prescription drugs.

H---- chemicals. Z---- Chinese medicine. J---- imported drugs. S---- biological drugs OTC - over-the-counter drugs

The approval number of health food is: State Food and Health Word Year Number Number

The others are non-drugs and non-health food; such as: XX Wei Food Word XX Food and Health Word XX Consumption Word, etc.