#CEMarking

[4-cconsulting]

UL and CE Certification: Ensuring Product Safety and Compliance

Ensure product safety and compliance with UL and CE certifications. Trust in our quality standards for peace of mind. Learn more.

[regulatorysolutionsindia]

Regulatory Pathway for In vitro diagnostics (IVD)

Registration in India: IVDs have become integral components of modern healthcare across the globe to support the diagnosis, monitoring, and personalized treatment of diseases. IVDs are also in very high demand in India, where the IVD market was worth about USD 2.64 billion in 2023 and expected to grow at a CAGR of 7.17% from 2024 until 2030 by Scania Analytics. As a result, the demand, interest, and enthusiasm of foreign IVD manufacturers to register and enter the Indian market have peaked. 

However, before IVD devices can be introduced to India, manufacturers and importers must navigate a complex regulatory pathway. Moreover, understanding the registration process is crucial for entry into the Indian marketplace. This blog will help manufacturer and importers understand the IVD registration process in India, discussing the critical components necessary obtain a market launch in India. Keep reading for details.

What are IVD Devices?

IVD Devices (in vitro diagnostics) are instruments employed to analyze biological samples (e.g., blood, tissue, urine, or other bodily fluids) outside of the human body. These tests are integral in providing valuable indications for the diagnosis of disease, monitoring a patient’s condition, quantifying certain substances, and identifying infections. More familiar examples of in vitro diagnostic devices are pregnancy test kits, COVID-19 test kits, blood glucose monitoring kits, immunoassays, and human genetic testing devices.

Which Authority Regulates IVDs in India? 

The authority in charge of licensing and regulating IVDS in India is the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.

How IVDs are classified?

IVDs are classified into four classes based on risk factors:

Class A: Low risk IVDs. Eg. Clinical chemistry analyzer (not near patient testing).

Class B: Low moderate risk IVDs. Eg. Pregnancy test strips, anti-nuclear antibody testing, urine test strips.

Class C: Moderate high risk IVDs. Eg. Blood glucose self-testing system, Human leukocyte antigen (HLA) typing, prostate-specific antigen (PSA) screening.

Class D: High risk IVDs. Eg. HIV blood donor screening,  ABO/Rh(D) blood grouping analyser (near patient testing).

Central Licensing Authority’s Role in Regulating IVDs 

The Central Licensing Authority is responsible for:

• Providing a license for the import of all classes of IVDs. 

• Regulating the manufacture of Class C and Class D (high risk) IVDs.

• Providing the approval for clinical performance evaluation studies for new IVDs before they are allowed to be marketed in India. 

• Working with State Licensing Authorities to ensure that there is consistent oversight of IVDs post-marketing.

Responsibilities of State Licensing Authority in Controlling IVDs

According to the Medical Devices Rules, 2017, the responsibilities of the State Licensing Authority are:

• To grant the licenses for the manufacture, sale or distribution of Class A or Class B (low risk) In Vitro Diagnostic medical devices in their state. 

• To regulate the sale, stocking, exhibition and distribution of IVDs of all classes in their states.

How to register an IVD in India?

A manufacturer, importer or distributor can register an IVD in India by following these steps:

• Identify the Class of IVD: Identify the risk class for the device/personnel E or fQA Yo can more work. 

• Designate the Authorized Indian Rep(s): Authorized agent if the applicant is a foreign manufacturer.

• Complete the Application Form: along with all supporting documents, for the developer or authorized agent on the SUGAM Portal:

Manufacturer: Applies for the Manufacturing license on Form MD-3orMD-4--Class A & B apply on Form MD-3 or MD-4. Class C and D manufacturers, MD-7 or MD-8.

More information about how to obtain a device manufacturing license can be read in our article, “5 Easy Steps To Obtain Your Medical Device Manufacturing License.”

Importers: Can apply for not only the manufacture device license but the device Import license using Form MD-14.The process of obtaining a licensing device can be perused at our blog, “Medical Devices Registration for Import.”

• Application for Review: The CDSCO will review the documents and may inspect overseas manufacturing. For example, review of importers data or evidence, while for manufacturers for India, will assign a State Licensing Authority (SLA)/ CLA a full site inspection process.

• License Issuance: Subject to all requirements being fulfilled, if the CDSCO is satisfied, a manufacturing or import license will be issued that is valid for five years unless otherwise noted. 

How Regulatory Solutions India Can Help You?

If you have not registered your IVDs in India yet, RSI can assist you through the whole process. Having more than ten years in the medical device regulatory process, we have completed over 450 medical device registrations in all categories. 

We have worked with clients in over 20 countries and can assist with everything from submission to regulatory approval in an effort to facilitate the approval process and secure your place in the market quicker. Let RSI help with gathering your IVD registration in India, contact us today!

[avajosheph]

Ensure your medical devices meet European standards with CE Marking. Stay compliant and gain market access across the EU. Maven is a regulatory consultancy providing one-stop solution for the CE marking of your medical devices, providing overall support with technical documentation, identification of external testing and coordination with associate laboratory partners, generating UDI’s, EUDAMED registration, appointment of EC REP (European Authorised Representative) and coordination with notified body.

[aa66]

Ce Marking For Medical Devices

At I3C Global, we specialize in CE Marking for Medical Devices. Our expert team ensures your product meets the stringent regulatory requirements, making the approval process smooth and efficient.

🔍 What We Offer:

Comprehensive regulatory guidance

Technical documentation preparation

Clinical evaluation

Post-market surveillance

📈 With I3C Global, you can navigate the complex landscape of CE marking with confidence and bring your innovative medical solutions to patients across Europe.

[thxnews]

Digital Leap Forward: UK Businesses to Embrace E-Labelling

A New Era for Business Compliance

UK businesses are on the brink of a significant transformation as new laws introduce digital labelling, marking a departure from traditional, physical labels for imports. This innovative move promises not only to reduce costs and regulatory burdens but also to align the UK's regulatory framework with the digital age. The initiative, made possible by Brexit, heralds a more flexible and modern approach to business regulations, ensuring the UK stays at the forefront of digital adaptation in global trade.  

The Drive Towards Digital Efficiency

For the first time, businesses will have the option to provide critical regulatory and manufacturing information online, eliminating the need for physical labels. This shift towards digital labelling is a response to industry demands for greater efficiency and cost-effectiveness in compliance procedures. It reflects a broader strategy to leverage digital technology in streamlining business operations, fostering growth, and enhancing the UK's competitive edge in the global marketplace.   Embracing Global Standards The move towards digital labelling is not just about cutting red tape; it's a step towards harmonizing the UK's regulatory standards with international practices. By adopting digital labelling, the UK aligns itself with other major economies, such as the United States, China, Japan, and South Korea, enhancing its trading relationships and positioning itself as a forward-thinking, digital-first economy.   Legislative Changes and Business Benefits The legislation to introduce digital labelling and the indefinite recognition of CE marking for a broader range of products underscores the government's commitment to supporting businesses. These changes aim to simplify compliance, lower costs, and offer greater flexibility in how companies operate and bring their products to market. The 'Fast-Track UKCA' process is another initiative that is poised to provide businesses with a streamlined route to demonstrate compliance, accommodating products covered by multiple regulations.  

Industry Reactions: A Collective Sigh of Relief

The response from industry leaders has been overwhelmingly positive, with key figures from the automotive, manufacturing, and tech sectors welcoming the reforms. The recognition of CE marking and the introduction of digital labeling are viewed as pragmatic decisions that will prevent businesses from incurring unnecessary expenses and complexity, ultimately benefiting consumers and ensuring high standards of product safety and quality.   Mike Hawes, SMMT Chief Executive: “Recognising CE marking indefinitely is very welcome and a common sense decision that will benefit the motorist and the competitiveness of the UK automotive industry. It means that thousands of aftermarket and supply chain businesses can continue to source vital automotive parts without unnecessary additional cost and complexity, keeping costs low for consumers and ensuring vehicles are built and maintained to the highest possible standards.”   Andrew Evans CEng MInstMC, Technical Director, The GAMBICA Association Ltd said: “UK suppliers of instrumentation, control, automation and laboratory equipment, within the membership of GAMBICA, appreciate the government’s engagement and practical steps to facilitate movement of goods across the GB border to ensure the long-term supply of critical components from a complex global supply chain.”   Stephen Phipson, CEO of Make UK, Stephen Phipson, said: “The addition of three further regulated sectors that will benefit from the indefinite recognition of current EU requirements including the use of CE marking, is a welcome move that manufactures who develop and sell products in these areas will very much welcome and support. “The added introduction of a ‘fast track’ process for products that are covered by multiple regulations, new permanent arrangements for labelling flexibility and an option for digital labelling, will all work together to help safeguard the competitiveness of manufacturers and aid the UK as a destination for investment. Make UK has called for the indefinite extension of a CE marking recognition for all UK manufactured goods to be a permanent change, and this should cover all goods and products sectors produced using a manufacturing process.”   Department Regulations in Scope of Announcement Regulations not in Scope of Announcement Department for Business and Trade Equipment for use in potentially explosive atmospheres Regulations 2016/1107 Construction Product Regulations 2013 Electromagnetic Compatibility Regulations 2016/1091 Lifts Regulations 2016/1093 Electrical Equipment (Safety) Regulations 2016/1101 Pressure Equipment (Safety) Regulations 2016/1105 Pyrotechnic Articles (Safety) Regulations 2015/1553 - Recreational Craft Regulations 2017/737 Radio Equipment Regulations 2017/1206 Simple Pressure Vessels (Safety) Regulations 2016/1092 Toys (Safety) Regulations 2011/1881 - Aerosol Dispensers Regulations 2009/2824 Gas Appliances (EU Regulation) 2016/426 - Supply of Machinery (Safety) Regulations 2008/1597 - Noise Emission in the Environment by Equipment for Use Outdoors Regulations 2001/1701 Personal Protective Equipment (EU Regulation) 2016/425 - Measuring Instruments Regulations 2016/1153 Non-automatic weighing Instruments Regulations 2016/1152 Measuring Container Bottles (EEC Requirements) Regulations 1977 Department for Environment, Food and Rural Affairs The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (‘The RoHS Regulations) - Department for Energy Security and Net Zero The Ecodesign for Energy-Related Products Regulations 2010 - Department for Work and Pensions (HSE) The Explosives Regulations 2014 - Department for Levelling up, Housing and Communities - Construction Product Regulations 2013 Department for Health and Social Care (MHRA) - The Medical Devices Regulations 2002 Department for Transport - The Railways (interoperability) Regulations 2011 Department for Transport - Merchant Shipping (Marine Equipment Regulations) 2016 Department for Transport - The Cableway Installations Regulations 2018 (SI 2018/816) and The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (SI 2019/1347) Department for Transport - The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 Department for Transport - Unmanned Aircraft Systems (UAS) Regulation 2019/945   In Summary The UK is setting a new standard in business regulation with the introduction of digital labelling, marking a significant shift towards modern, efficient, and cost-effective compliance measures. This change, enabled by the UK's exit from the EU, allows businesses to move away from traditional physical labels, opting instead to provide regulatory and manufacturing information online. This move not only cuts costs and reduces red tape but also places the UK in line with global digital practices, enhancing its trading relationships and bolstering its position in the international market. The legislation extends the recognition of CE marking across a wider range of products, providing businesses with greater operational flexibility and simplifying compliance processes. The introduction of a 'Fast-Track UKCA' process further streamlines the demonstration of compliance for products covered by multiple regulations, offering a more straightforward path for businesses to navigate regulatory requirements. Industry leaders have welcomed these reforms, emphasizing the benefits of reducing complexity and costs, which are expected to positively impact consumers and guarantee high standards of product safety and quality. They view the indefinite recognition of CE marking and the option for digital labeling as vital steps to maintain the UK's competitive edge and attractiveness as a destination for investment.   Conclusion The UK's initiative to introduce digital labelling and extend the recognition of CE marking represents a forward-thinking approach to regulatory reform. By embracing digital technology and aligning with international standards, the UK government is not only supporting business growth and innovation but also ensuring that the regulatory framework is adaptable, efficient, and suited to the needs of a modern economy. These changes underscore the UK's commitment to fostering a business-friendly environment that prioritizes the ease of compliance, reduces unnecessary expenditures, and promotes a competitive market. As the UK continues to navigate its post-Brexit landscape, these measures signal a commitment to regulatory excellence and economic resilience, setting a benchmark for others to follow.   Sources: THX News, Department for Business and Trade & Kevin Hollinrake MP. Read the full article

[elexesofficalblog]

FDA - Medical Devices Advisory Committee

The U.S. Food and Drug Administration (FDA) has 31 advisory committees responsible for the evaluation and regulation of drugs, medical devices, and biologics.

The advisory committee protects and promotes public health while meeting the requirements established in the Federal Advisory Committee Act.

Committees are either mandated by statute or established at the discretion of the Department of Health and Human Services.

The advisory committee has multiple roles in developing and evaluating New Drugs, Biologics, and Medical Devices.

Their primary goal lies in assisting the FDA to evaluate applications for Pre-Market Approvals (PMAs) of medical devices, New Drug Applications (NDAs), and Product Licensing Agreements (PLAs) for biologics. The committees include chairperson, members, a consumer, industry and sometimes a patient representative.

Medical Devices Advisory Committee

Medical Devices Advisory Committee supports the FDA to protect and promote public health. The committee consists of 18 panels with a maximum of 159 standing members.

The selection of members is carried out by the Commissioner or designee from among authorities in Clinical and Administrative Medicine, Engineering, Biological, and Physical Sciences, etc.

The panel advises the FDA on the safety and efficacy of the medical devices except for the Medical Device Dispute Resolution Panel.

According to the respective specialty area, the panel advises the commissioner of Food and Drugs regarding recommended classification or reclassification of devices into one of three regulatory categories.

For recommendations of medical devices with respect to regulatory aspects, the committee reviews and evaluates the issues related to clinical study designs on the safety and effectiveness of marketed and investigational medical devices.

Overall, the 17 panels except for the Dispute Resolution Panel (DRP) of the medical device advisory committee, advise the Commissioner in accomplishing the constraints in assuring the safety and effectiveness of the medical devices in accordance with their specialty ****area and authorization.

The advisory committee also plays a major supportive role to agency professionals and influence agency decisions. FDA calls meetings with the committee or with the advisory panel as necessary. Generally, each of the panels meet once a year or as per the requirements by the FDA and important regulatory decisions or discussions are carried out in these meetings.

It is important that Manufacturers have a regulatory and quality team that stays abreast of decisions concerning their products and any such decisions or discussions are preemptively taken into account for a speedy FDA clearance, approval or compliance activities.

[adamsbrown01]

In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA). To gain approval for a medical device technical file in Australia, manufacturers are required to create a Technical File or Technical Documentation, which contains detailed information about the design, manufacturing, and performance of the device. Consulting with regulatory experts or the TGA is advisable to ensure that your Technical File meets all necessary criteria.

[jonesmiller001]

Technical Files for medical devices in the UK are essential documents that contain comprehensive information about the design, manufacturing, and performance of a medical device. These files are a crucial part of the regulatory process and are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. It's important to note that the specific requirements for Technical Files can vary based on the classification of the medical device and any updates or changes in regulations. Consulting with our regulatory experts or agencies like the MHRA is advisable to ensure that your Technical File meets all necessary criteria.

[regulatorysolutionsindia]

Regulatory Pathway for In Vitro Diagnostics (IVDs) | FDA 510(k), EU IVDR, Compliance Guide

Are you working in MedTech or regulatory affairs and need clarity on how In Vitro Diagnostics (IVDs) are approved and brought to market?

In this post (and video), we explain the entire regulatory pathway for IVDs, covering:

🔹 What are IVDs? 🔹 Classification of IVDs (Class A, B, C, D) 🔹 FDA 510(k), PMA, and EUA pathways 🔹 EU IVDR and CE marking 🔹 Clinical evaluation, labeling, and compliance

Whether you're a beginner, student, or experienced professional, this breakdown will help you stay compliant and competitive in the medical device industry.

[allensmith01]

Technical Files for medical devices in the UK are essential documents that contain comprehensive information about the design, manufacturing, and performance of a medical device. These files are a crucial part of the regulatory process and are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Consulting with our regulatory experts or agencies like the MHRA is advisable to ensure that your Technical File meets all necessary criteria.

[moveleftslightly]

CE, March 24th 2019.

I have never been overly political but it was/is hard to ignore the furore surrounding Brexit. Back in 2019 I finally dismantled the kiddimoto our children started riding on. I noticed the CE mark on it, is this image a metaphor for the whole Brexit situation perhaps? The rot set in a while back and the handle bar snapped, I repaired that and got a little more use out of it. Finally it was too far gone and the wheels fell off. Will the kids ever understand the significance of these photographs? Time will tell.

[sushvin-consultancy-services]

CE Mark Extension in the UK: How Sushvin Consultancy Supports Medical Devices Regulatory Compliance Until 2030

The UK MHRA has extended the acceptance of CE-marked medical devices until June 30, 2030 under specific conditions. In our latest blog, Sushvin Consultancy breaks down what this means for manufacturers and how we can help ensure seamless regulatory compliance during the transition to UKCA marking.

💡 Learn how to stay compliant, manage certification changes, and prepare your technical documentation. 📌 Explore action steps, deadlines, and our expert guidance.

📖 Read now: https://www.sushvin.com/uk-ce-mark-extension-medical-device-compliance.html

[iso27001certificationinqatar]

What is CE Marking ? Understanding CE Marking for Qatar-Based Businesses

As Qatar continues to grow as a global business hub, companies looking to expand their reach into the European market must understand the importance of CE certification. Whether you are manufacturing electronics, machinery, medical devices, or construction materials, obtaining CE marking is essential for compliance with European standards. This guide will help Qatar-based businesses navigate the CE certification process and ensure smooth access to the EU market.

What is CE Certification?

CE certification, or the Conformité Européenne (European Conformity) marking, is a mandatory conformity mark for products sold within the European Economic Area (EEA). It indicates that a product complies with the health, safety, and environmental protection standards required by European regulations. For businesses in Qatar looking to export to Europe, CE certification is not just an advantage—it is a legal necessity.

Why is CE Certification Important for Qatar-Based Businesses?

Market Access �� CE certification in Qatar allows products to be freely traded within the 30 countries of the EEA, opening doors for increased business opportunities.

Compliance with International Standards – By obtaining CE certification, businesses align with globally recognized safety and quality standards, enhancing brand reputation.

Avoiding Trade Barriers – Non-compliant products can be rejected at European borders, causing financial losses and delays.

Customer Confidence – European consumers and businesses prefer products with CE marking, as it guarantees compliance with rigorous safety and performance standards.

Legal Requirement – For many product categories, selling without CE marking in the EU is illegal, which can lead to penalties or recalls.

Which Products Require CE Certification?

Not all products require CE marking, but some major categories include:

Electrical and electronic equipment

Medical devices

Machinery and industrial equipment

Construction materials

Toys

Personal protective equipment

Pressure equipment

Measuring instruments

Before starting the CE certification process, businesses must determine whether their products fall under the CE directives.

Steps to Obtain CE Certification

1. Identify Applicable Directives and Standards

Different products fall under different EU directives, such as the Machinery Directive, Low Voltage Directive, or Medical Device Regulation. Understanding which directives apply is the first step.

2. Conduct a Conformity Assessment

The assessment process varies depending on the product category and its associated risks. It may involve self-assessment or third-party testing by a Notified Body (NB).

3. Perform Product Testing

Products must undergo rigorous testing to meet EU safety and performance standards. Many Qatar-based companies collaborate with accredited testing laboratories to ensure compliance.

4. Compile a Technical File

A technical file must be prepared, including:

Product specifications and designs

Risk assessment reports

Test results

Compliance with relevant standards

User manuals and labeling details

5. Prepare the Declaration of Conformity (DoC)

The DoC is a legally binding document where the manufacturer declares that the product meets the EU requirements.

6. Affix the CE Marking

Once compliance is confirmed, the CE marking can be affixed to the product. It should be visible, legible, and permanent.

7. Ensure Ongoing Compliance

Compliance does not end after certification. Regular monitoring, quality control, and documentation updates are required to maintain CE certification status.

How Qatar-Based Businesses Can Facilitate CE Certification

1. Partner with Certification Experts

Many businesses work with CE consultant in qatar that specialize in CE marking. These experts guide manufacturers through the complex certification process.

2. Utilize Accredited Testing Labs

Testing in ISO-certified laboratories ensures that products meet EU standards before submission.

3. Stay Updated with EU Regulations

CE implementation in Qatar regulations evolve over time. Businesses must stay informed about changes to maintain compliance.

4. Implement Strong Quality Management Systems

Adopting ISO 9001 and other international quality standards enhances the certification process and reduces the risk of non-compliance.

Conclusion

For Qatar-based businesses aiming to export to Europe, CE certification is an essential step toward success. By understanding the requirements, conducting thorough testing, and working with certification experts, companies can ensure compliance and seamless market entry. Investing in CE marking not only facilitates EU trade but also enhances product credibility and customer trust worldwide.

If your business is considering CE certification, now is the time to take action and expand your reach into the European market.