CE Mark Certification Consultants in South Korea

CE mark certification in SOUTH KOREA is a product certification which is frequently known as passport to Europe. It seems to be very complicated but it’s just a process where you have to understand the steps, treat new products as a project, create plan and follow the plan in order to comply with the standard requirements. The standard focuses on below mentioned areas which have to be focused on an hour to get certified:

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ISO Certification Consultants in South Korea
  • CE Mark Certification Consultants in SOUTH KOREA specifies the requirement of classification – the questions to ask what are the products, what are the characteristics of the product, what are the EU legislation that are applicable to the product and what are the requirements under applicable legislation. The most important things to evaluate, what are you as a manufacturer claim the product is intended to do, product fulfilling the intended purpose. Product classification is one of the soul and entire responsibility of the manufacturer.
  • CE Mark Certification Consultancy in SOUTH KOREA specifies the requirement on identification- identify and determine the essential safety and health requirements then you identify the conformity assessment procedures, European harmonized standards, ensure product compliance, define and identify if the European approved authorized representative is required, determine if the notified body is required in order to get certified and identify if notification for the authorities is required.
  • CE Mark Certification Agency in SOUTH KOREA specifies the requirement on technical documentation – the manufacturer to execute the conformity assessment procedure, testing, assessments, evaluation, audit, inspections Etc. To document all the in the form of evidence of conformity. Responsibilities of proving the conformity is on the manufacturer. Issue declaration of conformity, technical documentation should be available for the EU regulation.
  • CE Mark certification Consultancy in SOUTH KOREA specifies the requirement for certification – the questions the manufacturers should ask is it required for my product type, can I certify myself or should I designate third party to get certification,, what application process what will I receive after completion of audit.
  • CE Mark Consultancy in SOUTH KOREA specifies the requirement for product packaging – once audit has been completed and you received a certification you can mention or a fix the logo on the packaging material. It is confirm it from a manufacturer that it is free from danger and it meets the safety and environmental aspects as mentioned by EU regulations.
  • CE Mark audit services in SOUTH KOREA specify the requirement of national requirements – Europe is not yet a single country there are 28 different nations that requires the national requirements. This requirement can be made post completion of CE certification.

There are three ways to get your products certified which are mentioned as below:

  1. Self-certification or self-declaration – this standard is a very beautifully designed and drafted where the manufacturer can himself self-declared or certify that it meets all the standard requirement and it is free from danger.
  2. notified body certification – This certification will be achieved after completion of test conducted on your product, After successful clearing the test your product will be certified from a notified body.
  3. non notified body certification of a compliance certification – this is a third party certification where a certification body or a third party inspection company will certify your product as she certified based on the declaration of conformity submitted by the manufacturer. Will not be any test conducted on the product neither the technical documentation shall be written for the same.

CE Mark Consultants in SOUTH KOREA is one of the product certification which shall be recommended post investigating the product on its risk and other factors to ensure that it is safe and healthy for the end user to use it. CE Mark certification in SOUTH KOREA is one of the certification what is very much essential for all of the manufacturers to stay active and profit it within the competitive market edge. End users as per the analysis in the recent time tend get attracted towards the product which are certified to International standards. Earlier if you had to export your products to European markets you should have mandatory got your product certified into CE Mark Certification in SOUTH KOREA. We help you to make you understand in depth about this certification and its requirement. In order to know more about the product certification you should first have a clear understanding that there are three ways with which you can get your product certified namely:

1) self-certification our self-declaration: This is one of the way in order to get CE Mark certification registration in SOUTH KOREA which provides the flexibility to the manufacturers who manufacture no risk products can get their products certified by this methodology. Manufacturer by preparing the self-declaration or declaration of conformity stating that as a manufacturers taking the soul responsibilities on the performance of the product in a safe and healthy way and accountable for all the health and safety issues if occurred in future on usage of this product. CE certification registration services in SOUTH KOREA by this methodology ensures the end user that the product is free from danger and it is absolutely safe to be used. This is one of the methodology which is used on a rare case to case. Manufacturers are aware that with this type of CE registration in SOUTH KOREA brand value will always have an effect. Some of the small scale industries manufacturing products with no risk and budget use this mode of certification for their product. When there is no Assurance from any of the third party CE registration services in SOUTH KOREA will not have that much effect on the marketing of the product so it is best advised that it is always better to avoid this kind of certification which will not have any of the impact on marketing techniques.

2) Non notified body certification: CE Mark Certification Registration in SOUTH KOREA provides the next version of the self-certification as compliance certification. This is one of the methodology where a third party inspection agency or certification body issues a certification or a recommendation that the manufacturers is following all the CE services in SOUTH KOREA and Standards which is free from danger and can be used safely. In this type of methodology manufacturers will submit the declaration of conformity document and take the soul responsibilities on health and safety issues which might cause in future. This is just an assurance by a third party organisation stating that CE audit in SOUTH KOREA has been successfully completed on the product performance and it needs the standard venturing haft generic equivalent requirement. This type of certification will not involve any of the involvement from the notified body. CE Mark certification in SOUTH KOREA will be briefly explain to you after you have a clear understanding on what is a notified body certification. The cost of CE Mark certification in SOUTH KOREA for notified or non-notified body depends upon the criticality of the product. Also time duration required to complete this process depends upon the risk and other factors involved.

3) Notified body certification: CE Mark Certification consultants in SOUTH KOREA should provide the necessary training’s on what are these bodies known as notified body. These are a third party inspection and certification body based out in European markets registered themselves with EEA regulations having unique number provided who have the authority to conduct a certification services post inspecting the product. Notified body certification becomes very much mandatory for all the medical products as European markets demands for a certification to be recommended by a notified body. CE Mark Certification in SOUTH KOREA has to provide the necessary guidance to the manufacturer that which type of methodology can be used in order to get your product certified for this International standard.

CE consultant services in SOUTH KOREA provides us the complete process as described below:

Firstly as a CE Consulting service provider in SOUTH KOREA you have to understand about the product functionality, intent of usage and technical specification so that you have a clear Idea on the product performance and other factors which will be helpful in the upcoming process of certification.

  1. CE consulting services in SOUTH KOREA has to next classify the product on the directives which are made available within the EEA regulations. All the information about the product directives are made available on various websites which can be referred in order to identify the applicable directives.
  2. Next if the product has been classified as a medical product under 93 / 42 /EEC directives then the CE certification consultants in SOUTH KOREA has to help the manufacturer to classify the products which are namely:

Class 1: These are those medical devices which have been classified as low risk. Some of the example for this classification would be hospital beds, wheel chairs, stethoscope, hospital furniture etc.

Class 2 : These are those medical devices as per consultant of CE Mark certification in SOUTH KOREA having medium risk for the end users on its usage and some of the example for this kind of products would be gloves, condoms, needle of syringe, contact lens, feeding pumps, dental filling materials etc.

Class 3: These are those medical devices as per CE consulting agencies in SOUTH KOREA having high risk on usage of this product and sum of the examples are surgical laser, infant incubator, contact lens solution, infusion pump, insulin pen, linear accelerator, steam sterilizer, electrosurgical unit etc.

Class 4: These are those medical devices as per consulting CE Mark Certification in SOUTH KOREA which have very high risk on the usage of this product and sum of the examples for this kind of products would be biopsy kit, breast implants, neuron endoscopy, iliac stent, implantable infusion pump etc.

  1. Next step as per CE consultancy in SOUTH KOREA would be to identify an accredited Laboratories with which you have to make sure that you test your product into end based on this standard requirement. It has to be insured that test reports are made available after certain test being performed on the performance of the product.
  2. Next very important step as per CE consultancy services in SOUTH KOREA is to document the technical files based on the performance and specification of the products. In order to build a document a technical file you can utilize the in-house available employees or help of Consultants.
  3. You have to understand if a non-notified body or notified body has to be involved for auditing your product based on the Standard requirements. Post clearing the audit non notified or notified body will provide the recommendation to the manufacturer that the product all the standard requirements and is free from danger.
  4. Post achieving the recommendation from the certification body the manufacturer has to make sure that as per CE Mark certification in SOUTH KOREA logo has to be affixed. There are certain rules and regulation in order to affix a logo and the consultants has to make sure that the necessary training’s has to be provided on affixing the logo.

Majority of the manufacturer’s within the city or confused on how to get CE Mark Certification in SOUTH KOREA who can guide on end to end standard requirements. For your question on how to get CE Mark Consulting services in SOUTH KOREA we are one of the leading Consulting organisation with a vast knowledge on product certification. In order to know more about the product certification and its requirement we request you to register your certification requirements with us today so that our expert can analyse your product and its performance so that we can have a clear Idea on the intend usage and other factors in order to provide you the plan with which we can get your product certified so that you can claim your products as certified.

How to get certified under CE Mark certification in SOUTH KOREA?

We one of the market leaders on consultation and certification of all the international standards on process and products which are available in market. We help our customers to identify whether your products needs to get certified in order to be sold in European market. Once identifying the requirement we help our customers to document process, identify the required EU directives and applicable standard for the product. With us the cost of CE certification in SOUTH KOREA is always feasible for our customers. We believe in customer satisfaction and help our customers to get certified at affordable and minimum time in order to export the product to European market and increase the profit margin.

How to get CE Certification in SOUTH KOREA?

If you are looking how to get CE mark certification Consultants in SOUTH KOREA you can write to us at [email protected] or visit our official website at www.certvalue.com in order to understand about our services and global presence. Our help desk personnel will be available 24/7 to assist you on your certification requirements and queries in order to make an arrangement for call conversation or face to face meeting in your office to help your product get certified. Our certification experts will understand your certification requirement better and provide best available solution in market.

 

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