Established a small medical device trading company in Suzhou, mainly engaged in three types of medical devices. What's the procedure? Please explain in detail as much as possible. Thank you.

Three types of medical devices are the highest standards in the medical device industry and need to pass GMP certification of the State Bureau. Before that, there are still many things you need to do. Let me give you a brief list, hoping to help you.

Procedures for establishing a new factory: market investigation → project establishment → project planning → site selection → design → completion → evaluation → acceptance → use.

Project establishment: The work before project establishment is generally called pre-project (mainly including project planning, feasibility study, preliminary design, etc. ), and the work after project establishment is generally called project implementation (mainly including construction drawing design, bidding, signing, procurement, construction and completion acceptance, final accounts and post-project evaluation, etc.). Due to the differences in investment subjects, investment industries, investment scale and project nature (for-profit and non-profit, etc.), the government has different regulations on project approval. According to the above elements, the investment projects are divided into four categories: forbidden, restricted, allowed and encouraged. Except for the prohibition of construction, the rest are subject to examination and approval system, approval system and filing system respectively. The stage of project approval, the materials to be submitted for approval, and other administrative licenses that should be obtained before approval are all different. Pharmaceutical preparations must comply with national laws and regulations.

The plan is divided into two parts: one part is for government departments to review, that is, the research report. One is the actual operation plan of the factory preparation, that is, the project plan. This should include major events and specific project plans (including financial aspects), the purpose of the project, the specific work to be done in each stage of the project, the coordination within the preparation, the coordination with government departments, relevant laws and regulations, acceptance specifications, the design of each unit of the factory, and the detailed design can be written in URS(GMP factory preparation) respectively.

I. Expected objectives of the project establishment and investment construction party:

(1) program

1, the applicant applies to the provincial drug supervision and administration department where the proposed enterprise is located. Within 30 working days, the company will review according to the industry development plan and industrial policy, and make a decision on whether to agree to the preparation.

2. After the establishment of the proposed enterprise is completed, the applicant shall apply to the original examination and approval department for acceptance. The certification of pharmaceutical production enterprises that produce injections, radioactive drugs and biological products specified by the drug supervision and administration department of the State Council shall be the responsibility of the drug supervision and administration department of the State Council.

3, the acceptance, issued a "drug production license".

4, the newly established pharmaceutical production enterprises, pharmaceutical production enterprises to build a new pharmaceutical production workshop or new dosage forms, it should be within 30 days from the date of obtaining the pharmaceutical production license or approval of formal production. (Application for product production license)

(2) scale

1, site selection (land purchase or lease)

2. Short-term planning and long-term planning

3. What products are produced?

4. What is the expected scale (daily output)?

5, according to the dosage form and process requirements to establish a factory.

Second, determine and form a leading body.

1, set up GMP leading group.

2. Hardware and software:

Generally, there is a general manager (investor) and two project leaders, one of whom is responsible for hardware (i.e. project engineering and equipment and facilities system); A responsible software (GMP office) is composed of various functional departments or responsible persons. (GMP certification and software can also be entrusted to qualified consulting companies. )

3. Recruitment and training of personnel

Third, according to the intention and recognition of investors.

The preparation, examination and approval of all kinds of license application materials required in the whole preparation process shall be submitted to the relevant departments for examination and supervision. Including the competent drug supervision department, the co-management departments are: water, electricity, gas, communication, fire protection, urban construction, environment and so on. The supervision departments are fire control, safety supervision bureau and technical supervision bureau.

Fourth, the production process

Verb (abbreviation for verb) purchases equipment, facilities and instruments.

Six, determine the construction plan, organization plan and project implementation.