BEŞİNCİ BÖLÜMKayıt ve Uyarı Sistemi

BEŞİNCİ BÖLÜM
Kayıt ve Uyarı Sistemi, Koruma Önlemleri, Denetim ve Yaptırımlar
Kayıt sistemi
Madde 16- Bakanlık, piyasaya arz edilmiş olan cihazları ve bu cihazların piyasaya arzından
sorumlu kişilerin kayıtlarını, aşağıda belirtilen esaslara ve verilere göre standart bir formata uygun
olarak tutar ve takip eder:
a) Cihazı kendi adıyla piyasaya arz eden üretici ve bu Yönetmeliğin 11 inci maddesinde
belirtilen faaliyetlerde bulunan gerçek veya tüzel kişi, Yönetmeliğin 9 uncu maddesinin (a) ve (b)
bendlerinde belirtilen işlemlere uygun olarak, işletme adresini ve cihazla ilgili gerekli bilgileri
Bakanlığa bildirir.
b) Cihazı kendi adıyla piyasaya arz eden üretici ülke sınırları dışında ise, yetkili temsilcisini
Bakanlığa bildirir. Yetkili temsilci, şirket merkezinin adresini ve cihazla ilgili gerekli bilgileri
Bakanlığa bildirir.
c) Bakanlık, bütün IIb. Sınıf ve III. Sınıf cihazlar için, şayet bu cihazlar iç piyasada hizmete
sunuluyorsa, cihazların etiketi ve kullanım kılavuzu ile birlikte sözkonusu cihazla ilgili tanıtıcı bilgileri
de talep eder.
d) Yurt dışından kullanılmış olarak ithal edilen ve iç piyasaya arz edilmek istenen cihazların, iç
piyasaya arz edilmeden önce bu Yönetmeliğin temel gereklerini yerine getirmesi şartı aranır. Bu
cihazların kayıtları da Bakanlıkça tutulur.
e) Bakanlık, bu maddenin (a) ve (c) bendleriyle ilgili olarak, talep olması halinde Müsteşarlık
kanalıyla Komisyon’a bilgi verir ve ayrıca, gerektiğinde Komisyon’dan bilgi ister.
f) Bu Yönetmelik ile ilgili düzenleyici veriler, yetkili kuruluşların bu Yönetmelik
çerçevesindeki görevlerini yerine getirmelerini temin etmek için onların ulaşabileceği bir Avrupa Veri
Bankası’nda saklanır. Veri Bankası, aşağıda belirtilen unsurlardan oluşur:
1) Bu maddede düzenlenen üreticinin ve cihazın kaydıyla ilgili veriler,
2) Ek II-VII’de öngörülen yönteme uygun olarak verilen, değiştirilen, ikame edilen, askıya
alınan, iptal edilen veya reddedilen belgeler ile ilgili veriler.
Uyarı sistemi
Madde 17- Cihazın piyasaya arz edilmesinden sonra tespit edilen olumsuzluklara ilişkin uyarı
sistemi şöyledir:
a) Bakanlık, I., IIa., IIb. veya III. Sınıf bir cihaza bağlı olan ve aşağıda belirtilen olaylar ile ilgili
olarak bilgisine sunulan verilerin, bu Yönetmelik hükümlerine uygun şekilde değerlendirilmesi için
gerekli tedbirleri alır. Bunlar:
8
1) Cihazın özelliklerinin ve/veya performansının bozulması veya sapması, hastanın veya
kullanıcının sağlık durumunda ciddi bozulmaya veya ölüme yol açabilecek veya yol açmış olan
kullanım kılavuzu ve etiketteki yetersizlikler,
2) Aynı tip cihazların üreticisi tarafından cihazın piyasadan sistematik olarak geri çekilmesine
yol açan ve bu bendin (1) numaralı alt bendinde belirlenen sebepler için bir cihazın özelliklerine ve
performansına bağlı teknik ve tıbbî sebepler.
b) Üretici veya üreticinin Türkiye dışında olması durumunda onun yetkili temsilcisi, hekim
veya sağlık kurum ve kuruluşları, bu maddenin (a) bendinin (1) numaralı alt bendinde belirtilen
durumlar hakkında Bakanlığı bilgilendirmek zorundadırlar. Bakanlık, hekim veya sağlık kurum ve
kuruluşlarından gelen bildirimlerle ilgili olarak cihazın üreticisinin veya üreticinin Türkiye dışında
olması durumunda onun yetkili temsilcisinin bu durumdan haberdar olması için gerekli bütün tedbirleri
alır.
c) Bakanlık gerekirse, üretici veya üreticinin Türkiye dışında olması durumunda onun yetkili
temsilcisi ile birlikte, konuyu yerinde inceler ve değerlendirme sonucundan, bu Yönetmeliğin 18 inci
maddesindeki hususlar saklı kalmak kaydıyla, Müsteşarlık kanalıyla Komisyon’a bilgi verir.
Korumaya ilişkin tedbirler
Madde 18- Bakanlık; bu Yönetmeliğin 12 nci maddesinin ikinci fıkrasında belirtilen ve EK-
VIII’e uygun şekilde ısmarlama üretilen cihazlar hariç olmak üzere; beyan edilen amaca uygun olan
cihazların kullanımının hasta, kullanıcı, uygulayıcı veya üçüncü kişilerin sağlık ve güvenliği açısından
tehlike oluşturduğunu tespit ettiğinde, bu cihazların piyasaya arzını engellemek, piyasadan çekilmesini
sağlamak, hizmete sunulmasını yasaklamak veya kısıtlamak için gereken bütün tedbirleri alır ve
aşağıdaki hususları da gözönünde bulundurarak, alınan tedbirleri Müsteşarlık kanalıyla Komisyon’a
bildirir.
a) Bu Yönetmeliğin 5 inci maddesindeki temel gereklerin ihlâli,
b) Bu Yönetmeliğin 6 ncı maddesindeki standartların yanlış uygulanması,
c) Standartların kendisinden kaynaklanan eksiklikler.
Bu Yönetmeliğe uygun olmayan bir cihaz CE işareti taşıdığında, Bakanlık, işareti kullanana
karşı gerekli tedbirleri alır ve Müsteşarlık kanalıyla Komisyon’a bilgi verir.
Usûlsüz olarak iliştirilmiş CE işareti
Madde 19- CE işaretinin usûlsüz olarak cihaza iliştirilmiş olduğunun tespit edilmesi halinde,
bu Yönetmeliğin 18 nci madde hükümleri saklı kalmak kaydıyla; üretici veya üreticinin Türkiye dışında
olması durumunda yetkili temsilcisi, Bakanlıkça belirlenen şartlar çerçevesinde, ihlâle son vermek
zorundadır. İhlâlin devamı halinde Bakanlık, cihazın piyasaya arzını kısıtlayıcı veya yasaklayıcı gerekli
bütün tedbirleri alır ve cihazın piyasadan çekilmesini sağlar.
Red veya sınırlama kararları
Madde 20- Bakanlıkça, bu Yönetmeliğin uygulanması sırasında cihazın piyasaya arzına,
hizmete sunulmasına ve klinik araştırmalarına yönelik red veya sınırlayıcı nitelikteki veyahut cihazların
piyasadan çekilmesine ilişkin olarak alınan herhangi bir kararda, karara esas alınan gerekçeler açıkça
belirtilir.
Birinci fıkrada belirtilen bütün kararlar için alınacak tedbirin aciliyeti, fikir alışverişi suretiyle
değerlendirme yapılmasına imkan veriyor ise, üretici veya üreticinin Türkiye dışında olması durumunda
yetkili temsilcisi, görüşünü önceden belirtme hakkına sahiptir.
Cihaz veya cihazlara ilişkin red veya sınırlama veyahut piyasadan çekilmesi iş ve işlemleri ile
ilgili olarak ayrıca, 17/1/2002 tarihli ve 24643 sayılı Resmî Gazetede yayımlanan Ürünlerin Piyasa
Gözetimi ve Denetimine Dair Yönetmelik hükümleri de uygulanır.

結果 (英文) 1:

THE FIFTH PARTRecording and warning system, Protection Measures, Control and SanctionsRegistration systemArticle 16-the Ministry, having been the supply of devices on the market, and these devices on the market offeringthe person responsible for the records according to the following principles and data in a standard format, appropriateholds and as follows:a supply manufacturer on the market under his own name) and in article 11 of this Regulationthe specified activities in the natural or legal person, the 9th article of the Regulation (a) and (b)in accordance with the process specified in the bend, business address and the required informationReports to the Ministry.b) Device on the market under his own name that is outside the bounds of the country's manufacturers, authorized representativeReports to the Ministry. The address of the corporate headquarters and authorized representative, that contains the information required to the deviceReports to the Ministry.c) Ministry, all Iib. Class and III. Class for the devices, if these devices are put into service in the domestic marketIf you are offered, along with the relevant tag, and user's Manual of the device to the device identifier informationdemands, too.d) imported from abroad, as it was used and intended to be internal market devices, internalessential requirements of these regulations before being offered to the market meet its requirement. Thisthe devices records are also kept by the Ministry.e) Ministry, this article is (a) and (c) in the case of the claim in relation to the bend of the Uftprovides information to the Commission and also with the channel, when necessary, requests information from the Commission.f) this regulation regarding regulatory data, competent organizations of this regulationwithin the framework of their duties to ensure that they can get them to bring a European DataBank is stored. The Data Base consists of the following elements:1) held in this article provided that the manufacturer of the device and the data associated with the2) Appendix II-VII in accordance with the method prescribed in the given, amended, suspended the substitution,received, canceled or rejected documents and related data.Warning systemArticle 17-the device on the market after the negativity of the warningsystem is as follows:a) Ministry, I, Iia, Iib. or III. Class, to a device that is connected to and below the specified events associated withthe data that is presented to the information, in accordance with these regulations for the evaluation oftake the necessary measures. These are:81) properties of the device and/or performance degradation or deviation, the patient orthe health of the user in the case of serious deterioration could lead to or have led to the death or theuser manual and inefficiencies in the label,the leading manufacturer of devices of the same type 2) by the withdrawal from the market of the device as a systematicled and this paragraph (1) is a device for the reasons specified in the properties andDepending on the performance of technical and medical reasons.b in the case of the Manufacturer or the manufacturer of the Turkey outside) its authorized representative, physicianor health institutions and organizations, this article is (a) of subsection (1) in the specifiedare required to inform the Ministry about the situation. The Ministry, the physician or health institutions andOrganization in relation to the notification from the device manufacturer or the manufacturer's Turkey outsidein the case of his authorized representative that all necessary measures to be informedgets.c) Ministry, if necessary, in the case of the manufacturer or his authorized manufacturer of Turkey outsideRepresentative examines and reviews at the subject, with the result that the regulation 18thwithout prejudice to article subjects, provides information to the Commission through the Uft.Regarding measures to protectArticle 18-the Ministry; This regulation is specified in the second paragraph of article 12 and annexVIII in accordance to bespoke manufactured devices including; the declared purpose isthe device is the use of the patient, the user, practitioner, or third party in terms of health and safetydetects constitutes danger, these devices on the market on block, clunkersbe submitted to the service provide to prohibit or restrict all required to take the necessary measures andthe following points are also considering measures to the Commission through the Uftdeclares.a) this regulation violation of article 5, basic needs,b) of these regulations, the implementation of article 6 of the standard,c) shortcomings in the Standards themselves caused.This moves it to a non-regulation equipment CE mark, Ministry, sign usetake the necessary measures against the and returns the information to the Commission through the Uft.As the CE mark attached to the bids willArticle 19-CE mark is found to be attached to the device, as bids willThis regulation is without prejudice to the provisions of article 18; other than the manufacturer or producer of Turkeyin the event that the terms set by the Ministry, within the framework of the authorized representative, ihlâle endmust be shown. In the case of a continuation of the violation, the Ministry released the device supply on restrictive or prohibitive requiredall the measures and provides the device's clunkers.Red or restrictions decisionsArticle 20-during the implementation of this regulation, without prejudice to the supply of the device on the market,presentation and clinical research service geared towards red or restrictive nature or deviceswith regard to the withdrawal from the market of any decision taken, the rationale underlying the decision clearlyis specified.All decisions will be taken to measure specified in the first paragraph, the urgency, the exchange of ideas throughallows to evaluate the manufacturer or producer of Turkey in the event of outsideauthorized representative, have to specify in advance the opinion.If the device or devices related to the withdrawal from the market or limit red or business and operations withalso, in relation to the 17/1/2002 and released the Official Gazette No. 24643 Products MarketSurveillance and Control also apply the provisions of That Regulation.

結果 (英文) 3:

CHAPTER FIVE
recording and the Warning System, the Protection Measures, Control and Sanctions
Recording system
Article 16- The ministry is available for those devices that are available and the equipment arzından
people responsible for records, and the following principles and according to the data in a standard format and the
as follows the:
a) device which is available for your own name and the manufacturer of this regulation will be in Article 11 If the activities in the real or legal person, regulations of Article 9 (a) and (b)
bendlerinde in accordance with the procedures outlined, the property address, and device-related information is necessary If the ministry.
b) appliance to your own name that are available manufacturer's country is outside of the borders.If an authorized representative informs the ministry. An authorized representative of the company address, and device-related information is necessary If the ministry.
c) The Ministry, all IIb. Class, and III. For Class devices, if the devices are internal market Finally is put into service, the devices if they are available from label and instructions for use with this device with the identifying information requested in the
.
d) imported from abroad, which has been used and the internal market to be offered the devices offer the inner
before it can be launched this regulation in order to meet basic conditions are searched. If the records of Ministry is held in.
e) the ministry, this provision (a) and (c) in the bendleriyle, Deputy in the event of a request
channel provides information to the Commission, as well as the necessary information from the Commission, whether it's.
f) This Regulation and the regulatory agencies, the data by this Regulation
frame to fulfill their tasks in order to provide a European Data which can be accessed by their
Base is stored in. Data Base, is made up of the following elements:
1) This in this article, provided the manufacturer's and the related data,
2) Attachment II-VII, in accordance with the procedure described in the given, the changed, substitute, controlled by
the suspended, canceled or rejected, the data documentation.
Warning system
Article 17- the market after the car has been offered for the fallout warning
system are as follows:
a) The Ministry, I. , IIa, IIb.or III. The device is connected to a Class and all of the following events as If information related to the data, so that according to the provisions of this Directive for the assessment of
take the necessary measures. These are:
8
1) and/or the performance of corruption or deviation, the patient's or
If a user's health serious deterioration or death or a road that can lead to a2 for the currently logged-on user's guide and poor,
2) is the same type by the manufacturer of the device to be withdrawn are commercially available as a systematic
on a path to it (1), in the lower the causes for the features, and a
Performance technical and medical causes are connected.
b) manufacturer or the manufacturer's Turkey out of its authorized representative in the event of a physician, or If the health care institutions and organizations this article bendinin (a) (1), the number of cases of the
have to inform. physician or healthcare, the ministry and institutions
organizations are from the device to the manufacturer or the manufacturer's out of Turkey in the event of a
its authorized representative for the state to be aware of all the necessary measures for the
.
c) The Ministry if necessary, the manufacturer or the manufacturer's out of Turkey in the event of its authorized representative If a topic, along with reviews and assessment outcome in place,This regulation will be
provision of 18 points to be provided to the Deputy to the Commission through provides information on measures to be taken to Protect.

Article 18- The ministry, this regulation will be referenced in Section 12 of the second and ADDITIONAL-
VIII, to custom-made the devices, with the exception that, in accordance with the purpose of
of patient, user,implementing agencies or third parties for the safety and health hazard that it Finally when the stock market, these devices are commercially available, to prevent from being pulled
to inhibit, the service to be offered or to restrict all of the required and Finally take the necessary measures shall be taken into account in the following manner, taking into account the measures through Deputy to the Commission reports that it Finally.
a) 5 provision of this regulation violation of basic requirements are met,
b) This regulation Article 6, incorrect application of standards,
c) due to lack of him.
this regulation is a device that does not have CE mark when mark, the ministry, you are ready to Finally take the necessary measures and Deputy to the Commission through the information.
Contrary to regulations, If an embedded CE marking CE marking Article 19- in which the device is attached, in the
18 of this regulation shall be provided to, and whether you are a manufacturer or the manufacturer's Finally out of Turkey in the event of a Ministry authorized representative, in accordance with the conditions to end the violations must Finally. In case where it happened, the ministry (continued)The stock market or on off buzzer inhibitor required restrictive
all and take the necessary measures to be drawn to the market.
Red or limiting decisions
Article 20- Ministry, this regulation will be available during the application of the supplies offered,
is put into service and clinical researches for a red or limitation of, or
to be withdrawn from the market price of any decision in the decision is Finally made it clear that the reason is indicated in the first paragraph.
all decisions would be taken to the exchange of views by urgent situation
assessment to be made if it is a chance, and not the manufacturer or the manufacturer's out of Turkey in the event of a an authorized representative If theit has the right to pre-Specify device or devices.
red or limitation of the market price, or towing operations and business, and Finally, as well as on 17/1/2002, and published in the Official Gazette 24643 of Market Surveillance and Inspection of SpO2 provisions of the regulation also applies to.