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CFDA Medical Device Certification China

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CFDA Medical Device CertificationFor the CFDA Medical Device Certification the China Food and Drug Administration (CFDA) recently released the 2016 Annual Report for National Medical Device Adverse Event Monitoring, which includes the general situation of medical device adverse event reporting, the statistical analysis of medical device adverse events, the intensive monitoring of medical device adverse event,the quality assessment of medical device adverse event reporting, and the release of medical device vigilance newsletter in 2016. The report reflects comprehensively the performance of China’s medical device adverse event monitoring in 2016.

CFDA issues Provisions for Medical Device Standards

To implement the newly revised Regulations for the Supervision and Administration of Medical Devices, China Food and Drug Administration (CFDA) organized the revision of the Measures for Medical Device Standards (interim), and formulated the Provisions for Medical Device Standards. The Provisions for Medical Device Standards was adopted at the executive meeting of China Food and Drug Administration on February 21, 2017, and shall be effective as of July 1, 2017.

The promulgation of the Provisions for Medical Device Standards will play a positive role in guiding China’s standardized management of medical devices, regulating the formulation and revision of standards, promoting the implementation and improvement of standards, and improving the quality of medical devices

CFDA issues Amendment to the Provisions for In-vitro Diagnostic Reagent Registration

China Food and Drug Administration (CFDA) issued the Amendment to the Provisions for In-vitro Diagnostic Reagent Registration (CFDA Order No. 30) on January 25, 2017, which shall come into effect as of the date of promulgation.

YY/T0287-2017 “Medical devices–Quality management systems–Requirements for regulatory purposes” officially released

On January 19, 2017, China Food and Drug Administration issued YY/T0287-2017/ISO13485:2016 “Medical devices–Quality management systems–Requirements for regulatory purposes”, which will come into force as of May 1, 2017.

YY/T0287-2017 idt ISO13485:2016 further stresses regulation, emphasizes the importance and necessity of implementing regulatory requirements, improves the compatibility of regulations and the standard; defines that the quality management system standard is applicable to medical device organizations at all stages of the full life cycle industrial chain, further guarantees the safety and effectiveness of medical devices at all stages of the full life cycle; intensifies the new requirements based on risk analysis and risk management; advances new requirements to medical device supply chain and procurement; and adds new requirements on the post-market surveillance and improvement of medical devices.

CE medical with offices in China and official partner for Certification Experts can manage the complete certification process and requires procedures for registration in China

May 26th 2017, critical day for Medical Devices in Europe

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On May 5th 2017 the Official Journal of the European Union published the new Medical Devices Regulation (EU) 2017/45. According to the new Medical Devices Regulation the Regulation enters into force on May 26th 2017. The current legislation on medical devices, i.e. the Medical Devices Directive 93/42/EEC, will be repealed with effect from May 26th 2020. As such there will be a transitional period of three years for all parties concerned with medical devices to adjust their activities in order to comply with the new Medical Devices Regulation.

This means that until May 26th 2020 compliance with either the old Medical Devices Directive or the new Medical Devices Regulation is sufficient to bring a medical device onto the European market. After the aforementioned period of time compliance with the new Medical Devices Regulation is mandatory. However, please note that even though a product model or type has been supplied before May 26th 2020 in compliance with the old Medical Devices Directive, when individual units of the same model or type are placed onto the market after May 26th 2020 they must comply with the new Medical Devices Regulation.

The new Medical Devices Regulation is a regulation while the old Medical Devices Directive is a directive. The difference is that a regulation is directly applicable to all Member States while a directive first needs to be implemented in national legislation by the individual Member States.

Further, the new Medical Devices Regulation goes more in depth and is more descriptive. To give an indication, the old Medical Devices Directive entails about 60 pages and the new Medical Devices Regulation is about 175 pages. The new Medical Devices Regulation explains a lot more definitions which covers a broader scope of compliance procedures.

It could occur that with the entering into force of the new Medical Devices Regulation certain medical devices could be classified differently when classified according to the old Medical Device Directive. For example, an asthmatic inhaler would fall under Rule 5 of the old Medical Device Directive indicating that it is a Class I medical device where, when classifying the same inhaler in accordance with Rule 20 of the new Medical Devices Regulation it is classified, dependent on the intended use, as either a Class IIa or IIb medical device. Therefore it is essential for the parties concerned with medical devices to re-evaluate and re-classify the medical device in accordance with the new Medical Devices Regulation.

The essential requirements, to which medical devices must comply, are more extensive in the MDR. More attention goes to software, electronic safety of active devices and electronic means of supplying information.

What will the new Medical Devices Regulation mean for you as a medical device manufacturer?

  • There is a transitional period of three years starting on May 26th 2017.
  • The Medical Devices Regulation is more descriptive and more in-depth, e.g. with regard to software, electronic safety of active devices and electronic means of supplying information.
  • Existing medical devices can be classified differently according to the new Medical Device Regulation.Is your medical device correctly classified according to the new Medical Devices Regulation? Contact CE Medical to verify whether the classification of your medical device is correct in accordance with the new Medical Devices Regulation.

Telephone: +31 (0)294 41 75 81
E-mail: info@ce-mark-medical.com.

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Is Standalone Software considered as a Medical Device ?

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In order to determine whether your standalone software is considered to be a medical device it must first be determined what type of operating software is to be used. For example, is your software online  software that runs through an internet browser, standalone software that operates without internet connection, or a program running separate from all computer processes. Continue reading

Three Essential Elements to Comply with the EU’s Medical Device Directive (MDD)

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Medical device manufacturers who want to bring their devices onto the Union market, must understand three essential elements when complying to the MDD. Device manufacturers that want to enter into the EU Market  need to understand three essential ideas: the role of the competent authorities, contract with an EU Authorised Representative, and how to use harmonized standards.

Competent Authorities

The primary role of the competent authorities is to protect the public health by ensuring that medicines and medical devices, entering into their respective Member States are safe and effective. Competent authorities also provide guidance to  Notified Bodies that operate within the borders of each Member State. Another vital role for the competent authorities is the postmarket surveillance and vigilance reporting. Finally, it is imperative that competent authorities cooperate with each other. Exchanging of vigilance, incident, and post-market surveillance information is an important requirement of the Directive.

European Authorised Representative

Device manufacturers that do not have a manufacturing presence within the EU, must contract a European Authorised Representative. Similar to a requirement imposed by FDA, the EU Authorized Representative is essentially the registered agent for a medical device manufacturer.

The Authorized Representative must:

  • Be the interface with the competent authorities for device incidents (vigilance reporting).
  • Act as an intermediary between the medical device manufacturer and the competent authorities.
  • Be responsible for incident reporting and field safety corrective action (FSCA) reporting.
  • Register medical devices with the national competent authorities.
  • Authorise the device manufacturer, through contracting, the use of their name and address on the product labelling.
  • Maintain a file copy of the technical documentation and design dossiers.
  • Maintain reports associated with the execution and performance of clinical evaluations.

Harmonised Standards

One thing which is always certain when dealing with European Harmonised Standards, is that standards are constantly changing. Significant changes were made to harmonised standards in 2012 and early 2013.

According to the European Commission:  “compliance with harmonised standards provides a presumption of conformity with the corresponding requirements of harmonization legislation. Manufacturers, other economic operators or conformity assessment bodies can use harmonized standards to demonstrate that products, services or processes comply with relevant EU legislation.”

Yes, harmonized standards are optional however  trying to get a product application approved without using them, is nearly impossible.

Ce Medical 

Certification Experts has many experience in guiding and supporting companies in the CE Process.  We will investigate available documentation, test your medical devices and support you throughout the whole process.

For more information or to request a call back, use one of these four methods:

  • Call us: + 31 (0)294 41 75 81
  • Email us: Info@certification-experts.com
  • Request a call back
  • Fill in our contact form

Is my product a medical device (MD)?

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Is my product a medical device (MD)?

To know if your medical product falls within the scope of the CE marking legislation you must ensure if the product is classified as a medical device as defined in Directive 93/42/EEC.

In the Medical Devices Directive (93/42/EEC) a medical device is defined as:
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Additional requirements for RoHS Directive

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The new European Union RoHS Recast Directive that comes into force on July 22 applies to all medical devices. The devices have to comply with some restrictions on certain metals that can become toxic and leach into groundwater, or become hazardous ash when incinerate. The banned materials include lead, cadmium, mercury and polybrominated flame retardants, which are commonly found in the electrical components of medical equipment.

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Experts remain dubious of E-cigarettes safety

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E-cigarettes have been a topic of conversation lately since experts aren’t sure whether these electronic cigarettes are a harmful alternative for smoking. The vaporizer cigarettes are metal tubes that are designed to look like real cigarettes and contain a cartridge filled with a liquid that is vaporized by a battery-powered heating element. Manufacturers say they are a healthy alternative for tobacco smokers who want to avoid inhaling smoke. However government and health agencies think otherwise.

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Members of the European Parliament move to tighten controls after implant scare

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STRASBOURG – The European Parliament is aiming to tighten controls on the safety of medical devices in the wake of a worldwide scare over faulty breast implants from France.

More than 16,000 women have had breast implants removed since it was found in 2011 that those from France’s Poly Implant Prothese (PIP) were twice as likely to rupture as rival brands.
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