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Terms
I. Institutions and personnel
1001
Enterprises should set up an organizational structure that is consistent with the management of the actual situation, and clearly define its responsibilities.
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Mechanism
Structure
Establishment
Documentation,
Job
Capability
1002
Enterprises should set up a quality management department or a full-time quality control officer, to exercise the function of quality management in the process of the enterprise
Operation process of the quality of the medical device with the The quality of medical devices in the process of the enterprise
business has the right to rule.
Medical device business enterprises operating in a single category should have a full-time quality control officer.
Medical device business enterprises operating more than two categories (including two categories) shall set up quality management organization, under the
quality management group and quality acceptance group.
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Mechanism
Structure
Establishment
Documentation,
Job
Capability
1003
Enterprise leaders (general manager) should have a college degree, there is no serious violation of the regulations on the management of medical devices
behavioral records.
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School
Certificates
Certificates,
Titles
Certificates of the original
* 1004
Enterprises should have the scale of operation and business varieties of the quality of management personnel, including referring to the quality
quantity management personnel, the quality management organization person in charge, quality control officer.
Quality management personnel (refers to the enterprise quality management responsible person) should have with the business scope of the appropriate professional
college degree or intermediate title,
3
years engaged in the quality management of medical devices
work experience.
The person in charge of the quality management organization shall have a college degree or above or
intermediate title or above in a specialty appropriate to the scope of business, and have
2
years of experience in quality management of medical devices.
Quality control officer should have a college degree or above in a specialty appropriate to the scope of business or a junior or above
title, and have
1
years of experience in quality management of medical devices.
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Certificates
Certificates,
Titles
Certificates original
* 1005
In addition to quality management personnel, the enterprise should have enough professional and technical personnel, the number of which should not be less than
2
persons,
Applying for the operation of medical devices. p>
Application for business scope in
4
more than 4
categories of professional and technical personnel should be not less than
3
persons.
Professional and technical personnel should have a college degree or above in a specialty appropriate to the scope of business or a secondary
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Certificate
Calendar
Certificates,
Title
Certificates of the original
Titles
Titles of grade or above.
1006
Personnel engaged in the sales, acceptance and warehousing management of medical devices should have a high school (including)
or higher education. Maintenance positions or other positions with high technical requirements should be equipped with professional
technicians.
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School
Certificates
Certificates,
Title
Certificates original
1007
Over the state legal retirement age of the personnel to serve as the quality manager of the enterprise, the quality management organization responsible for
Responsible person or quality control, the age of the quality control shall not be over
65
years old.
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Body
Certificate,
Medical examination certificate
Ming
1008
Enterprise legal representative or person in charge of the quality management personnel should be familiar with the supervision and management of medical devices
Regulations, rules, as well as the food and drug supervision and management department of Hainan Province on the supervision and management of medical equipment
relevant provisions. Quality management personnel should also be familiar with the technical standards of the products operated.
May
be
examined
by
answer
paper
or
present
questioning
questions
in
methods
* 1009
In principle, the person in charge of the enterprise, the quality manager, the quality manager, the quality manager, the quality manager, the quality manager, the quality manager, the quality manager, the quality manager, the quality manager, the quality manager and the quality manager shall be familiar with the technical standards of the products they handle. The person in charge of the enterprise, the quality manager, the person in charge of the quality management organization, the quality control officer, and the
professional and technical personnel shall not hold concurrent positions with each other or work part-time in other units. If the business category is
3
or less (including
3
), the quality manager can also be the head of the quality management organization.
The salesperson may not also be the quality inspector.
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Flower
Name
Register
* 1010
Retail stores dealing with medical devices full-time quality management personnel should have a secondary school education in related disciplines
or junior titles;
Pharmacies that also deal with medical devices can also be a full-time quality management personnel by the drugs. The pharmacies that also deal with medical devices can also have a full-time quality officer for medicines.
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Certificates
Certificates,
Title
Certificates
Original
1011
Enterprises dealing with implantation, intervention, and artificial organ products should be staffed with qualified medical technicians or professionally-trained personnel.
This is the first time that a company is required to provide medical equipment to its customers.
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Academic
Certificates,
Title
Certificates of originality,
Proof of training
1012
Businesses dealing in products of fitting and dispensing shall be staffed with qualified medical practitioners or professionally trained personnel.
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certificates,
title
certificates,
proof of training
1013
The person in charge of the enterprise, the quality manager, the person in charge of the quality organization, the quality control officer, the professional and technical personnel
as well as personnel engaged in the management of the sales, acceptance, repair and warehouse management
And the provincial drug supervision department should be after professional training
And provincial drug supervision department exams, and obtain a certificate of post qualification before taking up their duties.
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Competent
Qualified
Certificate
1014
Enterprises should be organized annually on a regular basis on the staff of the relevant laws, rules and regulations, and product technology
Standards, knowledge of quality management, professional ethics training, and the establishment of files.
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Training
Training
Files
1015
Quality managers, quality agencies responsible for quality control staff should be subject to the provincial pharmacovigilance department each year
Continuing education organized. Technical personnel and personnel engaged in sales, acceptance, maintenance and warehouse management
positions should regularly receive continuing education organized by the enterprise. Continuing education
Education of the above personnel shall establish a file.