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关于印发医疗器械生产企业飞行检查工作程序(试行)的通知

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关于印发医疗器械生产企业飞行检查工作程序(试行)的通知

国家食品药品监督管理局


关于印发医疗器械生产企业飞行检查工作程序(试行)的通知

国食药监械[2012]153号



各省、自治区、直辖市食品药品监督管理局(药品监督管理局):

  为加强医疗器械生产监督管理,规范医疗器械监督检查工作,根据《医疗器械生产监督管理办法》和《医疗器械生产日常监督管理规定》,国家局组织制定了《医疗器械生产企业飞行检查工作程序(试行)》。现印发给你们,请参照执行。


                            国家食品药品监督管理局
                             二○一二年六月十八日

  (公开属性:主动公开)


          医疗器械生产企业飞行检查工作程序(试行)


  第一条 为加强医疗器械生产监督管理,深化医疗器械监督检查工作,根据《医疗器械生产监督管理办法》和《医疗器械生产日常监督管理规定》,制定本程序。

  第二条 医疗器械生产企业飞行检查(以下简称“飞行检查”)是指食品药品监督管理部门根据监管工作需要,对医疗器械生产企业实施的突击性有因检查。

  第三条 飞行检查是食品药品监督管理部门对医疗器械生产企业实施监督检查的一种特殊方式。对于下列情形的监督检查,食品药品监管部门可采取飞行检查的方式实施:
  (一)对涉嫌违法违规企业的监督检查;
  (二)对发生重大产品质量事故企业的监督检查;
  (三)对国家质量监督抽验产品不合格企业的监督检查;
  (四)对质量管理体系存在严重缺陷企业的跟踪检查;
  (五)对生产企业信用管理记录中不守信企业的监督检查;
  (六)其他情形的有因检查。

  第四条 飞行检查过程中应对该企业前次质量管理体系检查中发现的缺陷或问题的整改情况进行检查确认。

  第五条 飞行检查由食品药品监督管理部门组织实施,包括检查准备、现场检查和检查结果处理三个阶段。

  第六条 检查准备阶段,飞行检查组织部门主要做好以下工作:
  (一)选派检查组。检查组一般由2名以上从事医疗器械监管的人员或具有医疗器械生产质量管理规范检查员资格的人员组成,必要时可邀请有关专家参加。
  (二)根据实施飞行检查的缘由,并参考企业日常监管档案中的有关信息,按照有关法规和文件的要求,制定详细的有针对性的检查方案。
  (三)确定检查时间。
  (四)填写飞行检查任务书(格式见附件1)。
  (五)组织检查组进行监督检查纪律学习。
  (六)必要时,适时通知企业所在地的下一级食品药品监督管理部门选派相关监管人员担任观察员协助检查。

  第七条 现场检查前,检查组成员应到指定地点集中,统一前往被检查的医疗器械生产企业。

  第八条 现场检查实行检查组长负责制。检查组长要组织检查组做好下列工作:
  (一)向被检查企业出示飞行检查任务书;
  (二)按照检查方案实施现场检查;
  (三)在检查过程中完成有关问题的调查、取证工作;
  (四)在现场检查记录表(见附件2)中如实记录现场检查发现的缺陷、问题及判定依据,并请生产企业负责人签字,加盖企业公章;
  (五)完成检查报告。

  第九条 现场检查过程中发现的缺陷或问题,被检查企业提出现场整改措施,经检查组确认可行的,允许企业现场整改;但检查组应在现场检查记录表中如实记录该缺陷或问题,并记录现场整改情况。

  第十条 现场检查过程中,如被检查企业对检查组发现的缺陷或问题有异议,检查组应听取企业的陈述、申辩。双方意见无法达成一致的,应如实记录有关情况,并请企业提交书面说明,作为飞行检查组织部门依据检查结果作出处理决定时的参考。

  第十一条 现场检查过程中,发现企业违法违规行为,应中止检查并将其移交企业所在地食品药品监督管理部门处理。

  第十二条 现场检查结束后,检查组应在3个工作日内向飞行检查组织部门提交检查报告(格式见附件3)。
  检查报告应至少包括以下内容:被检查企业信息、检查任务信息、检查过程及缺陷和问题的描述、对前次检查发现问题整改情况以及检查组处理建议等。
  检查任务书、现场检查记录表、企业说明材料以及现场检查过程中收集的证据等,应作为检查报告的附件一并提交。

  第十三条 飞行检查组织部门应根据检查组提交的检查报告,就检查结果进行评估,依法作出处理决定,并采取相应的处理措施。

  第十四条 知悉飞行检查任务的监管人员要严格遵守监督检查纪律,不得向无关人员或被检查企业提前泄露飞行检查信息。对违反有关工作纪律的人员,依法依纪处理。

  第十五条 本程序自发布之日起施行。


  附件:1.检查任务书
     2.现场检查记录表
     3.检查报告

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兰州市政务大厅收费项目缴费管理规定(试行)

甘肃省兰州市人民政府办公厅


兰州市人民政府办公厅关于印发《兰州市政务大厅收费项目缴费管理规定(试行)》的通知


兰政办发〔2005〕37号 二○○五年三月二十八日

市政府各部门,各有关单位:
现将《兰州市政务大厅收费项目缴费管理规定(试行)》印发给你们,请遵照执行。


兰州市政务大厅收费项目缴费管理规定(试行)

第一条 为加强对行政审批事项以及行政事业性收费(基金)或经营性收费(以下简称收费)的管理,维护国家利益,保护公民、法人和其他组织的合法权益,制止乱收费,提高办事效率,保证市政务大厅(以下简称政务大厅)的正常运转,根据国家有关规定,结合我市实际,制定本规定。
第二条 本规定所称收费是指经市人民政府批准进入政务大厅的各类审批事项所对应的,并且符合国家规定的收费。
(一)依据国家有关法律、省级地方法规的规定,经中央或省财政厅、省物价局法定程序批准的行政事业性收费,同意继续征收,保留的收费项目以财政、物价部门每年最新公布的目录为准;
(二)经物价部门批准的经营性收费;
(三)经市人民政府批准进入政务大厅收取的其他收费。
除以上规定的收费外,办理行政审批事项的部门不得向单位和个人收取其他费用。
第三条 所有经批准进入政务大厅的收费业务必须在政务大厅办理。对仍在原单位收费的,按违纪处理。
第四条 凡在政务大厅范围内有行政审批事项和收费活动的国家机关、事业单位(以下简称征管单位)和有缴纳收费义务的单位和个人,均适用本规定。
第五条 政务大厅内收费严格执行“收支两条线”管理的各项原则,收费的执收单位、征收政策、资金缴纳渠道和资金使用性质按原规定维持不变。
第六条 行政审批按规定不能收费,个别行政许可项目确需收费的,收费业务应与行政审批事项保持对应,实行行政审批事项与收费的统一规范化管理。征管单位应将行政审批事项承办件与收费或减免资料一一对应保管,不得漏件、漏费。
第七条 收费减免按中央和省级相关规定执行。
第八条 市财政部门是行政事业收费的管理部门,对收费政策、收费依据具有解释和管理权限。
第九条 缴费单位和个人缴纳行政事业性收费(含纳入预算、预算外专户管理的收费),采取现金或支票两种交款方式。
(一)纳入预算外专户管理的行政事业性收费,对采取支票交款的缴费单位,由各执收单位在政务大厅开设的办事窗口(以下简称“办事窗口”)开具“票款分离缴款书”,缴费单位在市商业银行政务大厅分支机构(以下简称“市商业银行”)交款后凭银行回执到办事窗口换取“甘肃省行政事业性收费票据”;对以现金交纳的,由各办事窗口开具“兰州市政务大厅缴费通知单(预算外)”,由缴款人到市商业银行缴款后,凭银行回执到办事窗口换取“甘肃省行政事业性收费票据”。
(二)纳入预算管理的行政事业性收费,对采取支票交款的缴费单位,由各办事窗口开具“一般缴款书”,缴费单位在其开户银行以转帐方式交入国库后凭银行回执到办事窗口换取“甘肃省行政事业性收费票据”;对以现金缴费的单位和个人,由各办事窗口开具“兰州市政务大厅缴费通知单(预算内)”,由缴款人到市商业银行缴款后,凭银行回执到办事窗口换取“甘肃省行政事业性收费票据”。各办事窗口于当日或次日填制“一般缴款书”,将待解国库专户资金以转帐方式交入国库。
第十条 征管单位应严格按照国家规定的收费项目依据、标准和范围进行收费,不得擅自提高收费标准和扩大收费范围。
第十一条 各征管单位审批窗口要严格把关,对没有履行缴费手续的审批件,不得加盖行政审批专用章。
第十二条 征管单位收费开具“行政事业性票款分离缴款书”和“一般缴款书”时,必须完整、准确地填报以下信息:
(一)收款单位全称、帐号、开户银行;
(二)执收单位全称、编码;
(三)收费项目名称、编码、金额。
第十三条 办事窗口必须使用财政部门统一印制的行政事业性收费票据。大厅内市级各部门派出机构票据的购领和发放按原规定执行,并按照以票管费的要求,行政事业性收费收入应及时、足额上缴国库或财政专户。
第十四条 收费和管理应实行公开,包括以下内容:收费项目公开、依据公开、标准公开、执收部门公开、收费对象公开、减免公开、收入公开。财政部门负责编制收费手册,随国家政策定期调整。
第十五条 开设财政专户的市商业银行应根据市政府对行政审批以及缴费管理工作的要求,提供优质服务,承担经济风险,保证各项资金的安全。
第十六条 任何组织和个人有权对收费管理工作中的违法行为进行检举和控告。政务大厅管理办公室对检举和控告的有功人员给予适当奖励。
第十七条 监察、财政、审计、物价部门对收费实行年度审验制度。监察、财政、物价等部门须对收费的项目、标准、征收范围、减免、资金上缴,以及使用票据等情况进行定期或不定期的检查。被检查单位应如实反映情况,提供相应资料,不得拒绝、阻挠。
第十八条 对违反上述规定的人员,按照有关规定予以处理。
第十九条 本规定由市财政局负责解释。
第二十条 本规定自发布之日起施行。


国家税务总局关于境外团体或个人在我国从事文艺及体育演出有关税收问题的通知(附英文)

国家税务总局


国家税务总局关于境外团体或个人在我国从事文艺及体育演出有关税收问题的通知(附英文)
国家税务总局



各省、自治区、直辖市、计划单列市税务局、文化厅(局)、体委:
一九九三年九月二十日我局与文化部、国家体委联合下发了国税发〔1993〕089号《关于来我国从事文艺演出及体育表演收入应严格依照税法规定征税的通知》,现对外国及港、澳、台地区团体或个人在我国(大陆)从事文艺演出和体育表演所取得收入征税的具体政策业务问题
,明确如下:
一、外国或港、澳、台地区演员、运动员以团体名义在我国(大陆)从事文艺、体育演出,对该演出团体及其演员或运动员个人取得的收入,应按照以下规定征税:
(一)对演出团体应依照《中华人民共和国营业税暂行条例》(以下简称营业税暂行条例)的有关规定,以其全部票价收入或者包场收入减去付给提供演出场所的单位、演出公司或经纪人的费用后的余额为营业额,按3%的税率征收营业税。
(二)演出团体凡能够提供完整、准确费用支出凭证的,依照《中华人民共和国外商投资企业和外国企业所得税法》(以下简称企业所得税法)的有关规定,应对演出团体的收入总额减除实际支出的费用后的余额,按30%的税率征收企业所得税,并按3%的税率征收地方所得税;对
演出团体实际支付给演员或运动员个人的报酬部分,依照《中华人民共和国个人所得税法》(以下简称个人所得税法)的有关规定征收个人所得税。
(三)演出团体不能提供完整、准确的费用支出凭证,不能正确计算应纳税所得额的,在计算征收企业所得税时,根据企业所得税法实施细则第十六条规定的原则,应以其收入总额减除支付给演员、运动员个人的报酬部分和相当于收入总额30%的其他演出费用后的余额,依照企业所
得税法规定的税率征收企业所得税和地方所得税;对上述支付给演员、运动员个人的报酬部分,依照个人所得税法的规定,由演出团体支付报酬时代扣代缴个人所得税。对没有申报支付给演员、运动员个人报酬额的或未履行代扣代缴义务的,应以其收入总额减除上述相当于收入总额30%
的其他演出费用的余额视为该演出团体的应纳税所得额,依照企业所得税法计算征收企业所得税和地方所得税。对演员或运动员个人不再征收个人所得税。
(四)对本条第(二)、(三)款中所述演出团体支付给演员、运动员个人的报酬,凡是演员、运动员属于临时聘请,不是该演出团体雇员的,应依照个人所得税法的规定,按劳务报酬所得,减除规定费用后,征收个人所得税;凡是演员、运动员属该演出团体雇员的,应依照个人所得
税法的规定,按工资、薪金所得,减除规定费用后,征收个人所得税。
二、对外国或港、澳、台地区演员、运动员以个人名义在我国(大陆)从事演出、表演所取得的收入,应以其全部票价收入或者包场收入减去支付给提供演出场所的单位、演出公司或者经纪人的费用后的余额为营业额,依3%的税率征收营业税;依照个人所得税法的有关规定,按劳务
报酬所得征收个人所得税。
三、对演出团体或个人应向演出所在地主管税务机关申报缴纳应纳税款的,具体可区别以下情况处理:
(一)演出团体及个人应缴纳的营业税,应以其在一地的演出收入,依照营业税暂行条例的有关规定,向演出所在地主管税务机关申报缴纳。
(二)演出团体应缴纳的企业所得税和地方所得税,应以其在一地的演出收入,依照企业所得税法及其实施细则和本通知的有关规定,计算应纳税所得额及税款,并向演出所在地主管税务机关申报缴纳。按本通知第一条第二款所述依实际费用支出计算纳税的演出团体,在全部演出活动
结束后,可在与其签订演出合同的中方接待单位所在地主管税务机关,办理企业所得税结算手续。
(三)演员、运动员个人应缴纳的个人所得税,应以其在一地演出所得报酬,依照个人所得税法的有关规定,在演出所在地主管税务机关申报缴纳。属于劳务报酬所得的,在一地演出多场的,以在一地多场演出取得的总收入为一次收入,计算征收个人所得税。
(四)主管税务机关可以指定各承包外国、港、澳、台地区演出、表演活动的演出场、馆、院或中方接待单位,在其向演出团体、个人结算收入中代扣代缴该演出团体或个人的各项应纳税款。凡演出团体或个人未在演出所在地结清各项应纳税款的,其中方接待单位应在对外支付演出收
入时代扣代缴该演出团体或个人所欠应纳税款。对于未按本通知有关规定代扣代缴应纳税款的单位,应严格依照《中华人民共和国税收征收管理法》的规定予以处理。
四、各中方接待单位在对外签订演出或表演合同后的七日内,应将合同、资料报送各有关演出、表演活动所在地主管税务机关,对于逾期不提供合同资料的,可依照企业所得税法及有关法规予以处理。
本通知自文到之日起执行。

CIRCULAR ON THE QUESTION CONCERNING TAX ON ARTISTIC AND SPORT PER-FORMANCES GIVEN BY OVERSEAS TROUPES OR INDIVIDUALS IN CHINA

(State Administration of Taxation: 21 April 1994 Coded Guo Shui Fa[1994] No. 106)

Whole Doc.

To the tax bureaus of various provinces, autonomous regions and
municipalities and cities with independent planning, to cultural
departments (bureaus) and to State Commission for Physical Culture and
Sports:

The Circular Concerning the Levy of Tax Strictly in Accordance With
the Stipulations of the Tax Law on the Incomes Gained From Artistic and
Sports Performances Given in China, was issued on September 20, 1993
jointly by our Administration, the Ministry of Culture and the State
Commission for Sports and Physical Culture, a document Coded Guo Shui Fa
[1993] No. 089. The concrete policy-related business questions concerning
tax levied on the incomes gained from artistic and sports performances
staged in China (Chinese Mainland) by troupes or individuals coming from
abroad and from the regions of Hong Kong, Macao and Taiwan are hereby
clarified as follows:

I. For performers and athletes from abroad or from the regions of
Hong Kong, Macao and Taiwan who stage artistic and sports performances in
China (Chinese mainland) in the name of organization; tax shall be levied
on the incomes gained by art troupes and their performers or by individual
athletes in accordance with the following stipulations:
(1) In line with the related stipulations of the Provisional
Regulations of the People's Republic of China Concerning Business Tax
(hereinafter referred to as Provisional Regulations Concerning Business
Tax), after subtracting the expenses paid to the units, performing
companies or brokers who provide performing venus from all income gained
from ticket price or from booking the whole theatre or stadium, the
balance shall be regarded as the business volume on which business tax is
levied at a 3 percent rate.
(2) For performing troupes which can provide complete and accurate
certificates showing their outlay of expenses, according to the related
stipulations of the Income Tax Law of the People's Republic of China on
enterprise with foreign investment and Foreign Enterprises (hereinafter
referred to as Enterprise Income Tax Law), enterprise income tax shall be
levied at a 30 percent rate on the balance of the performing troupes'
total income amount after subtracting the expenses actually paid and local
income tax shall be levied at a 3 percent rate; individual income tax
shall be levied on the remuneration actually paid by the performing
troupes to individual performers or athletes in accordance with the
related stipulations of the Individual Income Tax Law of the People's
Republic of China (hereinafter referred to as Individual Income Tax Law).
(3) For performing troupes which cannot provide complete and accurate
certificates showing the outlay of expenses and cannot correctly calculate
the amount of taxable income, while calculating and levying enterprise
income tax, in accordance with the principle stipulated in Article 16 of
the Detailed Rules for the Implementation of the Enterprise Income Tax
Law, enterprise income tax and local income tax shall be levied at the tax
rate stipulated in the Enterprise Income Tax Law on the balance of their
total income amount after subtracting the remuneration paid to individual
performers and athletes and other performing expenses equivalent to 30
percent of the total income value; with regard to the remuneration paid to
individual performers and athletes as mentioned above, individual income
tax shall be withheld by the performing troupe when it pays the
remuneration in accordance with the stipulations as set in the Individual
Income Tax Law, with regard to performing troupes which have not declared
the amount of payments of remuneration to individual performers and
athletes or fail to fulfill the withholding obligations, the balance of
their total income value after subtracting other performing expenses
equivalent to 30 percent of the total value of income as mentioned above
should be regarded as the amount of payable income of that performing
troupe, enterprise income tax and local income tax shall be calculated and
levied in accordance with the Enterprise Income Tax Law. No more
individual income tax shall be levied on individual performer or athletes.

(4) In regard to the remunerations paid by the performing troupe as
mentioned in Clauses 2 and 3 of this Article to individual performers and
athletes, the performers and athletes who are invited temporarily and are
not employees of the performing troupe, individual income tax shall be
levied on the income from labor service remuneration after subtracting the
prescribed expenses in accordance with the stipulations of the Individual
Income Tax Law; for performers and athletes who belong to employees of the
performing troupe, individual income tax shall be levied on the wage and
salary incomes after subtracting the prescribed expenses in accordance
with the stipulations of the Individual Income Tax Law.

II. For the incomes gained from performances staged in China (Chinese
Mainland) by performers or athletes from abroad or from Hong Kong, Macao
and Taiwan in personal name, the balance of incomes from all ticket price
or from booking whole theatre or venues after subtracting the expenses
paid to units, performing companies or brokers who provide performing
venus is regarded as the business volume on which business tax shall be
levied at a 3 percent rate; in line with the related stipulations of the
Individual Income Tax Law, individual income tax shall be levied on the
income from labor service remunerations.

III. With regard to performing troupes or individuals who should
declared payments of payable tax to competent tax authorities in the
location where performances are staged, the matter shall be dealt with
concretely in accordance with the following different situations:
(1) Performing troupe and individuals shall pay business tax, they
shall declare payment of business tax to the competent tax authorities in
the location where performances are staged on the income from performances
staged at one locality in accordance with related stipulations of the
Provisional Regulations on Business Tax.
(2) For the enterprise income tax and local income tax which the
performing troupe should pay, the amount of taxable income and tax payment
are calculated on the basis of the income from performances staged in one
locality in accordance with the related stipulations of the Enterprise
Income Tax Law and the Detailed Rules for its Implementation and this
Circular, the performing troupe shall declare tax payment to competent tax
authorities at the location where performances are staged. The performing
troupe which calculates tax payment on the basis of the outlay of actual
expenses as mentioned in Clause 2 of Article 1 of this Circular shall,
after the end of all performing activities, perform the procedures for
settlement of enterprise income tax with the competent tax authorities at
the location of Chinese reception unit with whom it signs the performing
contract.
(3) For the individual income tax which performers and athletes
should pay, they shall declared tax payment with competent tax authorities
at the location where performances are staged in accordance with the
related stipulations of the Individual Income Tax Law for the
remunerations gained from performances given at one locality. For income
belonging to labor service remuneration and performances staged on several
occasions at one locality, the total income gained from performances given
on several occasions at one locality is regarded as a lump sum income on
which individual income tax is calculated and levied.

(4) Competent tax authorities can designate various venues, halls,
theatres or Chinese reception units to contract to provide spaces for the
performing activities staged by performing troupes or individuals from
abroad, or from Hong Kong, Macao and Taiwan, they should withhold various
payable taxes for the performing troupes or individuals from the incomes
settled with these troupes and individuals. If the performing troupes or
individuals who have not yet cleared off various payable taxes in the
locality where performances are staged, when paying for the income from
performances to other units, the Chinese reception units should withhold
the payable tax owed by the performing troupes or individuals. Units which
fail to withhold the payable tax in accordance with the related
stipulations of this Circular shall be dealt with strictly in accordance
with the stipulations of the Tax Collection and Management Law of the
People's Republic of China.

IV. Various Chinese reception units shall, within seven days after
signing performance contracts with units from outside, send the contracts
and materials to competent tax authorities at the location where
performing activities are staged, those who fail to provide contracts and
materials by exceeding the time limit shall be dealt with in accordance
with the Enterprise Income Tax Law and related regulations.
This Circular goes into effect from the day of receipt of the
document.



1994年4月21日