One, site: office space of at least 30 square feet, there should be certain office equipment office furniture, etc., the warehouse is at least 15 square feet, there should be appropriate storage facilities and equipment.
Second, the personnel: the actual inspection, the requirements of at least three people present: the person in charge of the company - the person in charge of quality - quality inspectors
"The person in charge of the company": there is no educational requirements, no professional requirements, require familiarity with the industry, know business management, required to be the industry
"Head of the company": no educational requirements, no professional requirements, required to familiarize themselves with the industry, know how to operate and manage, required to be in the industry, really say how the company is actually operating.
"Quality": clinical medicine or related medical graduates. This person is required to graduate from a college or university; the actual check needs to provide the original. And provide this person's personal resume.
"Quality officer": the same requirements as the quality officer.
(The quality person is required to be in full-time employment, which means that you need to provide a certificate of separation)
The actual inspection, the above three people must be present.
Three, materials:
1, a copy of the product registration certificate, each medical device products need to get a copy of the product registration certificate.
2, the general agent to provide the "Medical Device Business License", the manufacturer to provide the "Manufacturing License", registration certificate, product registration form, while providing a copy of the business license, tax registration certificate and so on.
3, the general agent or manufacturer to the customer's "distribution contract" or "authorized distribution letter".
4, the distribution of product standards, national standards, industry standards, it is best to provide all, provide some can also, but must provide some.
All of the above copies need to be stamped with the other company's red seal.