I. General principles
(a) According to the "supervision and management of the production of medical devices" (State Food and Drug Administration Decree No. 12), the "Beijing Medical Device Software Product Supervision and Management Interim Provisions," combined with medical device software The actual situation of on-site review of enterprises, the development of this standard.
(b) This standard applies to the new medical device software enterprises to apply for the "medical device manufacturer license", "medical device manufacturer license" production address and production scope of the change and "medical device manufacturer license" renewal of the on-site review.
(C) the production of on-site review of the enterprise according to the "& lt; Medical Device Manufacturer License & gt; on-site review of the score sheet", the review score sheet is divided into four parts, of which the veto provisions of the two, the total score of 100 points, the content of each part and the score:
1. 40 points of qualification of personnel
2. 10 points of the site
3. Data 30 points
4. production equipment 20 points
(d) Passing standard:
"veto" a failure, that is, the review fails;
"veto" passes and the score rate of each part of 80% or more.
"Veto" qualified and all parts of the score rate of 80% or more as qualified;
"Veto" qualified and all parts of the score rate of 60% or more, of which, a part (or parts) less than 80%, the enterprise is required to rectify and re-examine the review is still unqualified, that is, the review fails;
"Veto" a failure, that is, the review fails;
"Veto" a failure, that is, the review fails "Veto article" qualified and a part (or parts) of the score is less than 60%, that is, the review is unqualified.
Two, scoring method
(a) according to the review of the scoring table in the review of the method of scoring; deduction of points, up to the points deducted until the article.
(B) according to the general rules of scoring: scoring is not suitable for quantitative provisions, according to the general rules of scoring scores. The actual score is equal to the full score of each provision multiplied by the score factor.
Score coefficients and meaning:
1.0 fully meet the requirements;
0.8 better implementation, but still need to be improved;
0.7 basically meet the requirements, part of the implementation of the better;
0.6 basically meet the requirements
0.5 has been carried out, but there are still some gaps;
0 did not work! The following is a summary of the results of the study.
(3) On-site review of the record of each part of the score rate = each part of the actual score / the sum of the part X100% . The "total" in the on-site review record should include the total real score and the total score rate. The total score is the actual score of each part of the total score rate = total score / total score X100%
Three, the review of the conclusions
After the on-site review, fill out the on-site review records in a timely manner. According to the review criteria, the on-site review concluded that qualified or unqualified, the reviewer should fill in the on-site review record of the "review conclusions" column review comments; on-site review
Conclusion of the rectification, the reviewer should fill in the on-site review record of the "rectification requirements" column rectification requirements
Conclusion of the on-site review, the reviewer should fill in the on-site review record of the "rectification requirements" column. "column fill in the rectification requirements, to be completed after the completion of rectification enterprises to fill in the completion of rectification and review conclusions. Reviewers, the person in charge of the enterprise
should be on-site review records signed and stamped with the official seal of the enterprise (if any).
Four, other
(a) The State Food and Drug Administration otherwise provided, according to its provisions.
(B) on-site reviewers shall not be less than two people. Reviewers must comply with the medical device approval work discipline.
V. "Medical Device Manufacturer License" on-site review records
Review matters: start-up change change
Reviewed by the enterprise:
Reviewed by the site:
Proposed production of products and specifications of the model number:
Serial number
Review team position
Name
Work unit
Position/Title
1
Team Leader
2
Team Member
3
Team Member
Review:
Serial No.
Review Items
Total Score
Actual Score
Rate
Reviewed Actual Score
Score rate
Review actual score
Review score rate
1
Personnel qualification
40
2
Site
10
3
Regulatory information
30
4
Production equipment
20 <
5
Total
100
Rectification Requirements:
Reviewers: , , the person in charge of the enterprise on January
Enterprises to complete the rectification:
Reviewers: , , the person in charge of the enterprise on February
Review Conclusion:
Reviewers: , , month
Enterprises to the conclusions of the review:
Reviewers: , , month
Remarks
I. Personnel qualifications (40 points)
1. Enterprises should have a reasonable organizational structure, with sufficient human resources.
(1) check the organization chart of the enterprise;
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(2) check the quality responsibilities of the relevant departments;
5
(3) check the list of registered personnel of the enterprise in charge of the enterprise and the head of each department.
5
2. The person in charge of development and testing should have a college degree or above or an intermediate title or above.
(1) Check the documents of education or title;
(2) Check the labor contract;
(3) The specialty studied should be similar to the technical discipline of the enterprise's production products;
(4) The person in charge of quality shall not be the person in charge of production at the same time.
(5) The developer should be able to compile the source program.
Veto
3. Enterprises should have licensed quality system internal auditors (applicable to the third category of production enterprises).
(1) no less than two internal auditors;
(2) check the labor contract;
(3) internal auditors can not be part-time between enterprises;
(4) check the content of ISO9000 and YY/T0287 internal auditor certificate.
Veto
4. Enterprises should have full-time software testers.
(1) check the labor contract;
(2) check the appointment letter;
(3) not less than two people;
(4) testers are not allowed to engage in development work.
(None, 10 points; 1 less 5 points.)
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5. The person in charge should be familiar with the "Regulations for the Supervision and Administration of Medical Devices", "Supervision and Administration of Medical Devices Manufacturing Enterprises" and other medical device-related regulations.
Ask at least 2 people in charge, which should include the person in charge of the enterprise.
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6. The proportion of engineering and technical personnel with junior titles or junior college education or above in the enterprise to the total number of employees is not less than 10%, and the third type of production enterprises should have no less than 2 full-time technical personnel with intermediate titles or junior college education or above in the relevant professions.
(1) check the roster and title (or certificate of secondary school education or above), calculate the ratio and record;
(2) check the labor contract.
(2 points for every 1% less, and 5 points for one less in the third category of enterprises.)
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Terms
Inspection Content and Requirements
Review Methods
Standard Score
Actual Score
Remarks
II. Site (10 points)
1. The management, development and should be independently set up by the enterprise; the storage warehouse storage space should be relatively independent;
2. The production site should be environmentally clean, well lit and compatible with its products and scale of production;
3. Enterprises should have a documented warehouse management system to ensure that the requirements of the inventory of products, and its content should include at least: according to the actual need for fire, dust, rodent, moisture, insect-proof corresponding provisions; inventory of products classified partition placement requirements. The actual operation of the enterprise should be consistent with the warehouse management system.
(1) check whether the three sites are independent;
(2) verification of the production site and the conformity of the production site documents;
(3) observation of the environment of the production site and the lighting situation;
(4) check the management system of the warehouse, which should include the "Inspection Content and Requirements" of the content. The contents mentioned in the "inspection content and requirements" should be included.
(5 points will be deducted for each non-compliance.)
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Third, regulations and quality management documents (30 points)
1. Enterprises should keep the production of products of the national, industry standards or registered product standards.
Check the product standards based on the products produced by the enterprise, such as not the national standard, line standard, should be registered product standards. The standard should be a valid version.
(No standard or version of the invalid deduct 10 points)
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2. Enterprises should be preserved with the production of products related to technical standards.
Check the standards cited in the enterprise registered product standards, the standard should be a valid version.
(Each less than 1 standard deduction of 5 points, no standard or version of the invalid deduction of 10 points.)
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3. Enterprises should save the laws, regulations, administrative regulations and regulatory documents related to the production and operation of medical devices.
Check whether the enterprise has collected and preserved the laws, regulations, administrative rules and normative documents related to medical devices.
5
4. Enterprises should keep quality management documents related to the production of products.
Check the enterprise production quality management documents catalog and document compliance.
(5 points for each missing copy.)
5
Clause
Inspection content and requirements
Review method
Standard score
Actual score
Remarks
Fourth, production equipment (20 points)
1. Enterprises should have sufficient development and testing equipment.
(1) check whether the development and testing of computers are separate;
(2) the development of software such as network version, should have more than one test equipment.
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2. Enterprises should have a documented management system for computer use, including at least regular data backup, virus checking and antivirus, encryption, master disk management.
(1) check the computer management system, should include "check the content and requirements" mentioned in the content;
(2) check the actual operation of the enterprise should be consistent with the computer management management system
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