Drug Administration sampling results: These medical devices can not be sold for the time being (with list)

Pharmaceutical Network November 20, 27 batches of products unqualified November 17, the State Drug Administration issued a national medical device supervision sampling results notice, in the semiconductor laser treatment machine, ultrasonic cleaning equipment, surgical clothing and other 5 varieties of products for quality supervision sampling, a total of 27 batches (Taiwan) products do not meet the standards.
medical device products that do not meet the standards of the sampling project include: Semiconductor Laser Treatment Machine 1 product: produced by Sano Show, USA, involving emergency laser terminators that do not meet the standards.
ultrasonic dental cleaning equipment 1 product: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Production, involving external marking of equipment or equipment components, input power does not meet the standards.
Surgical clothing 6 batch products: JilinFran Medical Technology Co., Ltd., Jiangxi Shulan Golden Ring Medical Technology Co., Ltd., Nanchang Demeikang Medical Devices Co., Ltd., Changdong Medical Devices Group Co., Ltd., Xinxiang City Rongjun Medical Devices Co., Ltd., Henan Province Yu'an Medical Technology Development Co., Ltd. production, involving Strong-dry (product key areas), swelling-strong-wet state (product critical areas), fracture-strong-dry state (product critical areas), fracture-strong-wet state (product critical areas), impermeability (non-critical areas of the product) do not meet the standards.
hemodialysis device 1 batch of products: Shanxi Huading Xinquan Medical Device Manufacturing Co., Ltd. production, involving removal rate does not meet the standards.
Medical skimmed cotton 18 batches of products: Cixi City Huabao Medical Supplies Industry and Trade Development Co., Ltd., Zhende Medical Supplies Co., Ltd., Henan Gore Medical Devices Co., Ltd., Henan Xinhuan An Gaoke Co., Ltd., Henan Yadu Industrial Co., Ltd., Xinxiang City HTC Weiss Co., Ltd., Xinxiang City Huakang Wei materials Co., Ltd., Xinxiang Huaxi Wei materials Co., Ltd., Exin Medical Devices Co., Ltd., Taizhou City Yonghong Health Materials Co., Ltd., Yangzhou City Yucheng Medical Devices Co., Ltd. production, involving acidity, sinking time, water absorption, surfactant substances do not meet the standards.
Unqualified products in accordance with the regulations of the State Drug Administration pointed out that the above-mentioned sampling found in the non-compliance with the standards of the products, the State Drug Administration has asked the provincial drug supervision and administration departments where the enterprise is located in accordance with the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Production and the Measures for the Administration of Medical Device Recalls and other regulations and regulations, timely administrative decisions and public announcement to the community.
the provincial drug supervision and administration department where the enterprise is located shall urge the relevant enterprises to carry out risk assessment of products that do not meet the standards for sampling, determine the recall level according to the severity of the medical device defects, actively recall the products and disclose the recall information;
According to Cypress Blue Equipment Observation, the State Drug Administration recently issued a number of notices on the flight inspection of enterprises, found that the enterprise quality management system is mainly flawed, mainly related to institutions and personnel, production management, quality control, adverse event monitoring, analysis and improvement, equipment, design and development.
way to see the real thing by not hitting the public, not greeting, and going straight into the business.
is this way, so is flight inspection.
for the flight inspection, is mainly concerned about the production quality management system of enterprises, professional inspection team not far from thousands of miles to the enterprise's purpose is to point out the problem, urge enterprises to carry out continuous improvement of the production quality management system.
In the inspection mode, the inspection will take the way of not informed in advance, do not say hello, do not listen to the report, do not accompany the reception, go straight to the grass-roots level, directly plug in the scene, to find the outstanding problems and weak links existing in the enterprise.
are there any other priorities in flight inspection when it has become normal? Below is a summary of the flight inspection terms compiled from public data collection for reference.
six major inspection points of medical devices (38 sub-projects) (i) Finance Department 1, payment accounts - to the public payment account.
2, payment vouchers - relevant personnel signed for approval.
3, account classification - monthly printing account categories (receivables, payables, balances).
4, the tax ticket and the accompanying document amount is the same.
5, with the goods peer document variety details and tax list varieties, the amount is consistent.
6, check the salary scale - pay record details.
(2) Administrative Department 7, check the roster of employees - personnel education.
8, training files - annual training plan, training papers, training courseware.
(iii) Procurement Department 9, supplier qualifications - licenses, GSPs, account opening banks, business licenses, general taxpayer qualifications, scope of entrustment, commission time, entrustment area.
10, suppliers with the goods peer list - color, document content, document fresh chapter style.
11, seal filing and the most recent purchase of bills check.
12, account opening license and transfer account number and tax ticket account number.
13, supply units - business scope (procurement site operation system to do procurement planning: check the scope, the system can be controlled).
(4) Sales Department 14, downstream customer information - medical institutions license, business license, power of attorney, copy of the principal's identity card, entrustment time (all stamped with fresh seal).
15, containing special drug mouth compound preparation (egg peptide) receipt ---sa delivery man, shipper, reviewer, delivery to the conseor, time."
16, cold chain drugs - transportation records, handover records, self-collection records, handover receipts (receipt document content - supplier unit, purchase unit, purchase time, shipping time, shipping temperature, delivery temperature, quantity of drugs purchased, amount, manufacturer, approval number, transporter, reviewer, salesman, ticket opener, purchase unit receipt signature, time, seal).
17, sales flow details--- including special drugs compounding Liu (compound licorice oral solution, aminophen cause, etc.) in recent months a large number of single purchases (20 bottles / box or more).
18, sales flow with details - termination (purchase unit - certificate "license" principal ID card copy, power of attorney).
(v) Quality Management Department 19, the company GSP documents - system, responsibilities, operating procedures.
20, drug quality files - the first camp variety files (the original electronic version of the document is not recognized).
21, the first enterprise - approval process (on-site exercise) random extraction of archival data.
22, acceptance - cold chain drug operation, inspection report, system operation process.
23, supplier file approval - approval form (relevant personnel system review, actual operation).
24, verification - cold car verification information, payment details, signed joint action, participate in the verification personnel.
25, verification - field operation.
26, cold car, insulation box - verification unit information, payment vouchers, taxes.
27, internal audit - special internal audit (signature, participants ask questions).
28, information administrator - ask questions (maintenance, use, set permissions, UPS) to assist in quality audit computer permission control (check permission management for vulnerabilities).
(6) The storage and transportation department 29, the drug classification --- the whole part of the cargo area (on the shelf).
30, treasury area - cool? At ambient temperature? 31, the total area of the reservoir area - shady library? M2 room temperature library? M2 Chinese medicine tablet bank? ㎡.
32, pharmaceutical stacking - mixing situation, spacing (off the wall, ground, pipe).
33, treasury equipment - temperature and humidity controller, dehumidifier, wind curtain machine, generator.
34, cold storage - use, drug classification stack code, cold chain drug receipt, acceptance, review, delivery.
35, insulation box - on-site drill operation box (questions).
36, drug storage conditions -- room temperature? Cool? 37, special management of drugs - storage management, receipt, acceptance, review, shipping operations.
38, cold chain drugs - receipt, acceptance, delivery, review, delivery site operation.
eight inspection key points (20 sub-projects) (i) quality management personnel 1, quality responsible for - hanging on (on-site system to take questions, ask wages).
(ii) Quality Management Department 2, the responsible person of the quality organization - hanging on (questions participated in the internal audit time, verification of participants, verification of the company's name).
(3) Finance 3, receivables, payables, balances (check whether there is any ticketing behavior).
4, employee salary scale - check and rely on the actual operation.
(4) special drug compound preparation 5, supplier information (business scope, tax tickets, vouchers, details).
6, purchase unit information A, cash purchase - check documents (signed by the corresponding principal).
B, check the 2015 purchase details - the purchase quantity is larger: re-check - qualification, sales notes, receipts.
7, extracted goods in the warehouse A, a batch of purchase quantity, sales quantity, inventory quantity.
B, provide details, corresponding batch with-shipment documents, tax tickets, transfer vouchers.
C, supplier information - business scope, account opening license number and transfer number and tax ticket account number is consistent.
D, inspection report, registered batch, drug quality file.
(v) Refrigeration 8, suppliers - data, modes of transport, means of transport, records (data, handover documents).
9, refrigeration emergency - how to deal with unexpected situations (car broken, insulation box temperature is too low too high, robbed, etc.).
10, on-site operation of refrigerated drug delivery drill.
11, on-site drill refrigeration drug delivery link (delivery operation, data how to buy units).
12, refrigerated drugs - delivery methods (test quality, transporter, salesman) how to choose both effective and quality of transport.
(vi) computer rights control - print paper files (corresponding to each person viewing system) 13, information administrator - feel free to modify the data (recorded?) Is there approval? 14, quality management department - how to review the authority of each post can effectively prevent non-overseer? A, suppliers - procurement (manager, in-house attendance; supplier business scope.
B, purchase customers (sales manager, salesman, sales Neller), business scope.
(seven) egg peptide drugs 15, insulin -- purchase, sale, inventory flow; upper house information, next home information; first batch of drug quality information, 16, special inspection of imported products - registration batch (first-time documents "first camp varieties" cardboard and system approval are seen) (eight) facilities equipment 17, verification - adventure head (how many), back-office operation management system (how to enter, how to operate, who can modify the data? )。
18, verification of participants - random sampling (see if there is fraud) verification time, participants.
19, verify all the information to inquire in detail.
20, check equipment purchase information, payment, and original tax tickets.
。