Medical network - February 22 February 14, 2017, the description should be immersed in the rose the masses in atmosphere, in the evening but was caught by the death of Kim jong-nam eyeball; By contrast, issued by the administration of state food and drug supervision and administration on the same day of the notification regarding the medical equipment management enterprise results (no. 22, 2017), "natural ability to absorb eyes decreases, but for YiXie business colleagues, really?
YiXie regulation thinking how to change?
When we read the related content, the deepest impression is the following two sections:
"State food and drug administration has asked the relevant provincial food and drug administration of the enterprise's illegal conduct investigation, serious processing in accordance with the law. If the circumstances are serious, shall be ordered to shut, the medical equipment business license until revoked. If the case constitutes a crime, shall be investigated for criminal responsibility according to law. The above illegal business case, the state food and drug supervision and management of administration will be rigorous."
"State food and drug administration has asked the relevant provincial food and drug administration shall be ordered to rectification within a time limit, the enterprises and supervise the enterprise earnestly rectification in place."
"Serious", "order" and "suspended" these words of practitioners formed a strong visual impact, the "national team" (the state food and drug administration bureau) what is the formula? After analysis, the writer tries to share with the reader to make the following --
1, continuity, promote step by step
Practitioners must not forget announcement no. 2016, 2016 (medical equipment management enterprise audits), surely that means "national team" to a baseline screening for the industry, has been completed, in order to verify the "city" "provincial" (the provincial food and drug administration, similarly hereinafter) work, organization flight check immediately, to work in 2016 is summarized; Then choose released in 2017 at the beginning of the lunar nodes of the content, the universality and effectiveness at the same time announcement in guarantee warning effect (dare I say, most of the enterprise staff only after February 14, is basic to enter work status).
2, regulators, and practitioners to combine
This announcement involving enterprise of guangdong province (2), (1) in heilongjiang province, Beijing (1), jilin province (1) and (2) in jiangsu province, guizhou (1) (2), tianjin, Shanghai (2) and (1) and a series of medicine of hunan province, the equipment management big province, was flying, province of some enterprises is even more than a dozen not conform to the requirements of clause (" medical equipment management and the quality control standard "), the operator of the high-pressure situation, but in another Angle to think, the "provincial and municipal team" to see their jurisdiction was flying inspection enterprise, have the feeling of shame and beaten face? So, in fact, regulatory pressure is not small. So, after valentine's day, around the regulatory situation how will shift from don't have to say.
3, the focus is turning to fly
If you don't often focus on administration site medical instrument flight check module, might as well now into the state food and drug administration website look at 2016 flying inspection notice, violations of most of the medical device manufacturing enterprise, while flying inspection has suddenly turned to business, the direction key need not say oneself.
Moreover, familiar with the laws and regulations readers should know that, in view of the medical equipment management industry, national way about the following:
2013-2014: began to gradually improve the rules and norms
In 2015: laws and regulations to promote
2016: a baseline screening, source operation (registration and production)
So 2017? Must start to optimize industry structure. An important direction in optimization of must be eliminated, and the flight check again just is an effective means of elimination, isn't it?
How YiXie fly inspection content?
Talk about the intent, might as well talk to check content.
We take the CFDA about profit good biological technology co., LTD., 13 medical equipment management enterprise results announcement no. 22 (2017) in the guangdong hexin biological technology co., LTD., the case of violation of terms and conditions:
A careful analysis of the enterprise in violation of provisions, will find that the following features:
1, check to carefully
Was found in the enterprise are involved in the quality system documents very detailed content, in order to not lucky hexin biological technology co., LTD. Of guangdong province as an example, is to "create the" reagent and instrument purchasing management system "(document number: HX - ZZ - 08-00) and the reagents and equipment sales and after-sales service management system" (document number: HX - ZZ - 11-00) expressly procurement and sales record retention time ".
, word for word, from the general administration of writing, apparently came to the conclusion after we see the quality management system, and before that, the depth of the verification is not so, so, "with a piece of the sky, the same set of system" or "the same province, two or three sets of templates" may be a thing of the past.
2, wide range of cold chain for verification
Eight was serious processing enterprise, two for cold chain management have been under the terms and conditions, and the inspection range is not only in the medical equipment management and the quality control standard, also involves easily neglected the medical equipment cold chain (transportation, storage) management guide; Such as "not an enterprise developing cold chain management of medical equipment in the temperature control in the process of storage, transportation emergency plan" that violations of article, from the medical equipment cold chain (transportation, storage) management guide article 9. So, cold chain products enterprises, beware of "combination" laws and regulations.
3, highlighting "the seven key"
See the announcement, longitudinal throughout mastered the seven key points, as follows:
Legitimacy: 1. The personnel, warehousing and business address
2. System requirements: have, whether the actual
3. The cold chain and equipment validation and calibration (note: the category of calibration is not only cold chain equipment, also need to normal temperature measuring equipment)
4. "the four big record" : procurement, acceptance, outbound review with sales
5. The first camp qualification: is there, whether the record, is controllable
6. The computer system: whether is perfect
7. Handle non-conforming product: destruction of records
So, the individual thinks, the enterprise from the several points to start the rectification of oneself, should be a good way.
Industry development always has a timeless routines - early unfocused, lover's honeymoon, the bondage of the family.
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