Certease is one of the renowned & leading professional CE Consultant in Malaysia, providing CE mark certification services in Malaysia & other major cities such as Kuala Lumpur, George Town, Ipoh, Johor Bahru, Kota Kinabalu, Kuching, and Shah Alam.
With our extensive experience and in-depth knowledge of legal & regulatory compliance of the CE standard in Malaysia, we offer tailored solutions to ensure a seamless certification process which covers the end-to-end requirements of CE certification in Malaysia.
Our services include consultation, technical documentation, testing, inspection & certification. Whether you’re a small start-up or a large enterprise, Certease is committed to helping you achieve CE Marking certificate in Malaysia In the most efficient and Fast-track CE certification in Malaysia.
The CE mark, short for Conformité Européenne (European Conformity), is a symbol placed on products which are sold within the European Economic Area (EEA). This is a mandatory conformity marking on the products which are to be sold within the European Economic Area (EEA) since 1985.
CE mark Malaysia signifies that the product complies with health, safety, and environmental protection standards set by the European Union (EU). The CE mark is mandatory for certain product categories, including machinery, electronics, medical devices, toys, and construction products.
To obtain CE certification services in Malaysia, manufacturers must ensure their products meet all the relevant EU directives and regulations requirements through a conformity assessment process, which may involve testing, documentation review, inspection and quality control procedures to make sure the product is safe for the end user.
The CE mark in total has around 24 European directives & it is required in all 27 member states of the EU, and other countries such as Iceland, Norway, and Liechtenstein, Switzerland & Turkey also want some of the products to be CE Mark certified in Malaysia.
A CE directive in Malaysia is a set of rules by the European Union ensuring products sold in Europe meet safety and quality standards set by a specific directive.
For example: for a battery to be CE certified in Malaysia it has to adhere to the requirements set by Electromagnetic Compatibility (EMC) Directive 2014/30/EU. If a product meets these rules & requirements of the applicable directive, it receives a CE mark certificate, indicating it’s safe for sale within the EU & fit for usage.
Whereas a CE regulation in Malaysia is a legal framework established by the European Union (EU) unlike directives, regulations become directly applicable law across all EU member states without needing to be transposed into national legislation.
The simple answer is Yes! More than one or more directives or regulations can applied to a single product let again take an example of a battery, here at least 2-3 different directives are applicable.
CE mark consultants in Malaysia play a vital role in guiding businesses through the complex CE mark certification process and help companies in obtaining CE certificates for their products.
The main reason to hire a CE consultant is that they can assist businesses in understanding the specific requirements applicable to their products based on relevant EU directives or regulations based on which consultants can conduct a thorough assessment of product design, manufacturing processes, product drawings and documentation to identify areas of non-compliance and recommend if there are any changes to be made within the product design or CE documentation in Malaysia.
Moreover, CE mark consulting services in Malaysia include valuable assistance in preparing technical documentation or technical file creation, risk assessments, and conformity assessment reports required to apply for CE marking in Malaysia. Our CE consultants ensure that all documentation & reports meet the necessary criteria set by EU authorities, facilitating a hassle-free CE mark application process in Malaysia.
Additionally, Certease consultants provide value addition services which include training and support to internal teams & the staff to make sure the businesses maintain compliance beyond the initial certification. We provide continuous assistance 24/7 in monitoring regulatory changes and updating product documentation when needed to ensure continued conformity with changing EU standards.
Overall, CE mark consultants play a vital role in simplifying the CE certification journey for businesses across the globe, ensuring timely compliance, and enabling products to access the European market while minimizing risks and maximizing efficiency and safety.
The cost of obtaining CE certification in Malaysia depends upon various factors such as product category, location, complexity, the CE certification body in Malaysia which is chosen and other various factors.
The other fees may include are such as consultancy fees, testing & assessment charges, certification charges, documentation preparation & audit fees as well. On average, obtaining a CE certificate in Malaysia can range from a few hundred to several thousand euros.
If the product is critical or belongs high-risk category like CE certification for medical devices then the involvement of a notified body becomes mandatory the charges of a notified body are usually higher and require a longer time duration to get CE mark certification.
To get to know more details & exact cost of CE mark certification services in Malaysia you can fill out the enquiry form on our website with details one of our experts will share you detailed quote which will include end-to-end details about the process.
Below are the lists of products which require CE compliance in Malaysia:
Products which do not require CE marking:
The list includes the items below, but are not just limited to:
Let’s see how you can differentiate your products from others by obtaining a CE mark for your product. Getting your product CE Mark certified in Malaysia has numerous plus points. Below are some of the top benefits of CE certification in Malaysia.
1. Worldwide recognition: Getting CE marking ensures the free movement and marketing of the product in all EU countries, covering over 30 countries. Since CE in Malaysia is a globally known standard your product will have worldwide recognition
2. Continuous Improvement: Encourages ongoing quality improvements of the product and innovation to maintain CE compliance in Malaysia
3. Improved product & brand reputation: Having a CE mark on your product helps enhance brand reputation and credibility.
4. Health and Safety: The CE marking certificate in Malaysia ensures that products sold in the EEA meet the relevant health, safety, and environmental protection standards & requirements, hence protecting consumers, workers, and the environment.
5. Competitive Edge: Differentiates CE-certified products, boosting competitiveness & making your product stand out amongst your competitors.
6. Compliance with Legal & regulatory requirements: Ensures compliance with EU regulations & directives, and helps reduce legal risks and potential penalties.
7. Improved product safety: Prioritizes consumer safety through adherence to stringent EU health and safety standards. We are enhancing the overall quality & safety of the product.
8. Supplier Confidence: Getting your product CE compliant in Malaysia helps increase confidence among suppliers and partners, ensuring supply chain integrity
9. Increased Sales: Facilitates trade within the EEA, improving sales opportunities for certified products.
10. Consumer Trust: Having CE conformity on your product enhances consumer confidence by showing that your product meets strict safety and quality standards.
• An authorized CE mark certification agency in Malaysia or a EU authorized representative in Malaysia can only affix a CE marking on the product or issue a CE Mark certificate after the product is successful in meeting all the necessary CE mark requirements in Malaysia & clearance of audit or necessary inspections.
• A product cannot affix a CE logo in Malaysia unless it doesn’t fall or meet the applicable EU directives and regulatory requirements.
• The logo appearance of the CE marking should not mislead the relevant parties. The CE marking logo should be affixed on the product as per the prerequisites mentioned in the EU’s legislation. Logo assistance or help to be taken from a consulting firm to maintain integrity.
Wondering which directive applies to your product? The first step is to check & find out if your product is falling under one or more of the 24 CE directives which are mentioned below.
If your product falls under any of these directives, the next steps are to check the requirements of the directive and make sure your product fulfils all the needs of that specific directive or regulation. Once done you are good to get it CE marked in Malaysia.
An EU declaration of conformity (DoC) in Malaysia is a mandatory & most important document that you as a manufacturer or your authorised EU representative need to sign for your to declare that your products comply with all the necessary EU requirements.
By signing the DoC you or the EU authorised representative take complete responsibility for your product’s compliance with the applicable EU regulation or directive. This is one of the most important documents for your product to declare compliance with the CE marking.
The CE mark Declaration of Conformity document should include the following details – your or the EU authorised representative name and full business address, a Description of the product such as model, serial number, type & description of the product next it should include Directives and regulations used for the CE marking certification.
List of testing or harmonized standards used (If any), a written statement, stating that you take the entire responsibility that the product complies with essential requirements of the applicable European CE Directives or Regulations.
you also need to include the details of the notified body which carried out the conformity assessment procedure (if applicable), name, position and signature of you or the EU authorised representative, and the date of declaration when it was issued.
Below is the list of CE mark compliance checklists or CE mark documentation requirements in Malaysia to get your product CE compliant:
Step 1: Determine Applicable Directives & regulation to your product: find the specific EU directives or regulations that are applicable based on the product category and its intended use.
Step 2: Assessment of the product: Conduct a thorough assessment of the product to determine & understand its conformity with the requirements outlined in the applicable directives or regulations.
Step 3: Select the type of Conformity Assessment Module: based on the product category and level of risk select the suitable conformity assessment module, which may 3rd party compliance certification, involvement of a notified body, or type examination.
Step 4: preparation of technical documentation: Prepare detailed technical documentation of the product, which should include design specifications, product drawings, test reports, risk assessments, instruction or user manuals, and other relevant & necessary documents related to the product.
Step 5: Perform Tests on the product: Conduct applicable tests and inspections on the product to check performance and compliance with relevant EU standards and requirements. Testing may include mechanical, electrical, chemical, and safety assessments.
Step 6: Establish QMS in the organisation: To comply with European regulations, the organization needs to establish and maintain a Quality Management System (QMS). This system ensures adherence to industry standards. ISO 9001:2015 certification or equivalent quality standards may be mandatory.
Step 7: Declaration of Conformity (DoC) Creation: Create and sign a formal document called a Declaration of Conformity (DoC). In this document, you’ll declare and confirm that your product meets all the requirements outlined in the applicable EU directives and regulations.
Step 8: obtain the certificate & affix the CE Marking logo on the product: Affix the CE mark on the product, packaging, or other relevant documentation after obtaining a CE certificate from a CE certification body in Malaysia indicating conformity with EU requirements and enabling free movement of the product within the European Economic Area (EEA) market.
Step 9: Keep Records: Maintain records of all documentation, test reports, and compliance records for audit purposes and ongoing compliance verification.
Step 10: Surveillance & Continual Improvement: regularly monitor the performance of the certified product and promptly address if there are any non-compliance issues or safety concerns that may arise.
CE mark audit process in Malaysia involves a detailed assessment of a product’s compliance with EU directives or regulations governing product safety and quality.
The audit would be conducted by EU-recognised auditors and technical experts; it includes on-site inspections, documentation & technical file review, review of test reports or internal inspection reports, and interviews with key personnel. The CE auditor in Malaysia identifies any non-conformity and provides recommendations for corrective actions.
The company must develop and follow a corrective action plan, implement necessary changes if needed, and undergo follow-up audits when necessary. Upon successful clearance of the audit, the product receives a CE mark certificate, confirming adherence to EU standards & regulations and enabling the sale of products within the European Economic Area (EEA).
If you are looking to get Online CE certification services in Malaysia consider engaging a reliable & reputed third-party CE certification agency in Malaysia. Connect with Certease’s CE mark consultants to get professional-grade help regarding the CE mark certification process.
You can find the details on our contact page on our website www.certease.com or you can reach out to the following number +91 89517-32524 or email address contact@certease.com to get an instant response from our CE experts in Malaysia. We provide Cost-effective CE certification solutions in Malaysia.
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