Comprehensive medical device solutions for your organization and products: Certifications, regulations and compliance
Expertise in MDR requirements
Navigate the complexities of MDR compliance confidently with SGS. We specialize in various device classes, ensuring your products meet stringent standards.
ISO 13485, UKCA, and MDSAP certification
Achieve certification for ISO 13485, UKCA mark, and MDSAP with SGS. Our comprehensive services guarantee compliance and market access.
Benefit from our global presence and local market understanding. Our experts speak the language and understand the culture, providing you with unparalleled support.
Integrated audit solutions
Save time and resources with our integrated audit solutions. We streamline the certification process, helping you achieve compliance efficiently.
Receive personalized support from our dedicated account management team. We tailor our services to meet your specific needs, ensuring a smooth certification process.
Benefits
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Ensure your medical device quality management system (QMS) meets ISO 13485 certification requirements with SGS.
Demonstrate your ability to consistently meet customer and regulatory requirements and your commitment to quality and patient safety.
United Kingdom Accreditation Service (UKAS)
What is ISO 13485?
Given the complex nature of the medical device industry, an effective QMS must be more technically driven and requires extensive documentation. ISO 13485 is the QMS standard that provides medical device manufacturers & allied supply chain partners with a framework to demonstrate that they consistently meet customer and regulatory requirements, and are committed to quality and patient safety.
ISO 13485 uses the process-based approach to ensure the quality of medical device design, manufacturing, installation and service – for all stages of the product life cycle.
ISO 13485 is a minimum requirement for medical device manufacturers and at the core of numerous international market access programs, such as the Medical Device Single Audit Program (MDSAP), CE and UKCA marks.
ISO 13485 scheme is applicable to:
- Manufacturer of Finished Medical Devices & In-Vitro Diagnostic Devices (IVD’s)
- Manufacturer of Components & Raw materials for medical devices
- Developers of Software as a Medical Device (SaMD)
- Service provider to medical devices like Sterilization services, Design, Packaging services
- Distributors, Warehousing & Logistic companies handling medical devices
We independently assess your Quality Management System (QMS) against ISO 13485 requirements and provide the certification required for market access.
At SGS, we can offer:
- ISO 13485 under NABCB accreditation, India
- ISO/EN ISO 13485 under UKAS accreditation
National Accreditation Board for Certification Bodies (NABCB)
European Notified Body CE1639
Medical devices accreditations we are notified for:
ISO 13485: Quality Management Systems
ISO 13485 is essential for medical device manufacturers, demonstrating their commitment to quality and patient safety. It uses a process-based approach to ensure consistency in design, manufacturing, installation, and service throughout the product life cycle. This standard is pivotal for organizations involved in design, development, installation, and services of medical devices. It facilitates regulatory compliance in areas such as management responsibility, resource management, product realization, and measurement analysis. Moreover, ISO 13485 forms the foundation of the Medical Device Single Audit Program (MDSAP).
Regulation (EU) 2023/607, released on 15th March 2023, provides extended timelines for certifying medical devices under the new MDR. The transition period extension is subject to conditions ensuring product safety and manufacturers' steps towards MDR compliance.
How can SGS India help?
SGS is the world’s leading Testing, Inspection and Certification company.
We operate a network of over 2,700 laboratories and business facilities across 119 countries, supported by a team of 99,250 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, safety and compliance.
EU Medical Device Regulation (MDR)
Global resources, local understanding
Dedicated account management
Updated timelines of EU MDR transition
SGS India offers a globally recognized ISO 13485 certification service, enhancing your business credibility in the medical devices industry.
Global Certification
Our worldwide presence ensures audits are conducted by local-language auditors, facilitating clear communication and understanding
Local-Language Auditors
We provide guidance to help you adhere to necessary regulations, ensuring your products meet all legal requirements.
Regulatory Compliance
We assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets.
Local Regulatory Certification
Benefits of Medical Device Certification and Regulatory Check
Navigating EU MDR, ISO 13485, MDSAP, Article 117 and UKCA mark requirements can be complex. Trust SGS to provide the expertise and support you need for a smooth certification process. Our comprehensive services cover all aspects of medical device compliance, ensuring your products meet national and international quality standards.
Contact us today to learn more about our services and how we can help you achieve compliance. Let SGS be your partner in ensuring the safety and quality of your medical devices.
Let SGS guide you through medical device compliances
EU MDR
The EU MDR 2017/745 came into effect in May 2021. All medical devices certified under the previous Medical Device Directive (MDD) must certify to the new requirements to ensure that they can continue to be sold in the European market. Our MDR certification services provide a one-stop solution for all your medical device certification needs.
As a medical device Notified Body (SGS Belgium NV – Notified Body 1639), we are accredited to certify almost all types of medical devices. Once certified with us, you will be entitled to use the CE 1639 mark on the devices and their labeling before placing the devices on the European Union market.
The certification process comprises of various steps starting from Application submission & review, contract agreement, onsite audits, technical file review, certificate issuance and ongoing annual audits & review.
Benefit from our global presence and local market understanding. Our experts speak the language and understand the culture, providing you with unparalleled support.
Discover the secret to effortless MDSAP compliance
MDSAP enables medical device manufacturers to undergo a single audit that is accepted by MDSAP member countries. As an Auditing Organization (AO), our MDSAP services help you to comply with the quality management system (QMS) regulatory requirements for the medical device regulatory authorities of Australia, Brazil, Canada, the United States and Japan.
The MDSAP audit process provides complete coverage of the requirements of ISO 13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes), the Quality Management System requirements of the Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169), the Quality System Regulation (21 CFR Part 820) and other specific requirements of medical device regulatory authorities participating in the MDSAP programme, including registration, licensing, technical documentation review and adverse event reporting.
How does MDSAP differ from ISO 13485?
MDSAP is based on ISO 13485:2016 but also covers the medical device regulations enforced in the following territories:
- Australia – Therapeutic Goods Act and regulations
- Brazil – ANVISA regulations for pre-market approval, GMP, and the requirements for product registration and post market surveillance
- Canada – Food and Drug Act and Medical Devices Regulation
- Japan – MHLW Ministerial Ordinance No. 169
- United States – FDA Quality System Regulation and the associated regulations for medical device reporting, recall, registration, device tracing and labeling
For medical device manufacturers, this means that compliance with one auditing program, MDSAP, will give them access to five markets.
Canada was the first country to require compliance to MDSAP. It initially began extending applications under the Canadian Medical Device Conformity Assessment Scheme (CMDCAS) in 2017 but since January 1, 2019, MDSAP compliance has been a mandated requirement.
Establish trust in global healthcare markets
Article 117 NBoP
To gain EU market access, drug-device combination medical products need to meet MDR Article 117 requirements. As a Notified Body, we provide MDR Article 117 assessments and certification to verify the compliance of drug-device medical products, such as:
- Pre-filled syringes
- Pre-filled pens
- Nebulizers pre-charged with a specific medicinal product
- Patches for transdermal drug delivery
- Pre-filled inhalers
Article 117 of the MDR
- Ensure that your drug-device combination medical products meet MDR Article 117 requirements
- Confirm that your device complies with the relevant General Safety and Performance Requirements (GSPR)
- Gain a conformity assessment statement for inclusion in the Market Authorization Application (MAA)
- Ensure free trade in EU markets
Why choose MDR Article 117 assessment services from SGS?
A holistic approach to EU MDR, ISO 13485, MDSAP, Article 117 and UKCA mark
Get your organization and products certified for:
MDR Article 117 (Notified body opnion)
EU MDR
Medical Device Single Audit Program (MDSAP)
Certifications
MDR Article 117 assessment
EU MDR and ISO 13485
ISO 13485/ EN ISO 13485
NABCB/UKAS
MDSAP
IVDR
To place medical devices or in vitro diagnostic (IVD) medical devices on the Great Britain (GB) market (England, Scotland and Wales), you must comply with UKCA mark regulations, including requirements from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
In addition, you must meet the UK Medical Device Regulations (UK MDR) 2002 requirements. The UK MDR currently mirrors the EU Medical Device Directives for medical devices and IVD devices. It applies to all medical device types, including Class I (sterile and measuring), Class IIa, Class IIb (implantable and non-implantable) and Class III devices, as well as IVD devices under List A, List B and self-test classifications.
As a UK Approved Body (0120), we can certify your quality system and technical documentation to verify that they meet the MHRA and UK MDR 2002 requirements and are ready for UKCA marking.
UKCA Marking
UKCA Mark
UKCA Marking
Contact
SGS India Private Limited, 4B, Adi Shankaracharya Marg, Vikhroli (West), Mumbai, Maharashtra, 400083, India
UKCA Mark
What is IVDR and why is it critical for your market access?
The In Vitro Diagnostic Medical Device Regulation (IVDR) – EU 2017/746 sets the standard for placing in vitro diagnostic (IVD) medical devices on the EU market. Replacing the previous IVDD, this regulation introduces stricter classification rules, enhanced scrutiny, and greater transparency, ensuring patient safety and robust device performance.
If your IVDs are not certified under IVDR, you cannot legally market them in the EU.
Key IVDR changes include:
- A broader scope of regulated devices
- Risk-based device classification (Class A to D)
- Increased oversight from Notified Bodies
- Enhanced post-market surveillance requirements
- Mandatory registration in EUDAMED and UDI system
Whether you're developing diagnostic kits, software-based tools, or genetic tests — IVDR compliance is non-negotiable.