LOREM IPSUMXXX

N° X • XXXXXXXX 2008XXX MAY • 2013MEDICAL DEVICES NEWS

INMETRO – HOW TO GET YOUR ELECTRICAL MEDICAL PRODUCT ONTO THE BRAZILIAN MARKET?

SGS MEDICAL DEVICES WEBINARS

SGS MEDICAL TECHNOLOGY SYMPOSIUM 2013

MEDICAL DEVICES SYMPOSIUM 2013: SGS SHARES EXPERTISE IN MEDICAL DEVICE REGULATIONS IN JAPAN, KOREA AND TAIWAN

SPECIAL POINTS OF INTEREST:

MEDICAL DEVICES NEWS MAY 2013

EDITORIAL

Dear Reader,

Welcome to the latest issue of our Medical Devices Newsletter.

Within this issue you will find the latest information on current MD issues, including:

• The necessary requirements to bring products onto the Brazilian market

• Where to view our two most recent webinars: ‘Preparing for the New Changes in Notified Body Audits and Technical File Reviews’ and ‘How to Undertake and Document a Clinical Evaluation’

• Information on the upcoming ‘SGS Medical Technology Symposium’ event being held in Munich on June 20

• SGS experts with the Medical Devices industry and influencers in Japan, Korea and Taiwan

We hope you find this issue informative and useful.

Best regards,

SGS Medical Devices Expert Team

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P. 2N° X • XXXXXXXX 2008XXX P. 2MAY • 2013

INMETRO – HOW TO GET YOUR ELECTRICAL MEDICAL PRODUCT ONTO THE BRAZILIAN MARKET?

MEDICAL DEVICES NEWS

For commercialisation of electrical medical products in the Brazilian market, the national health surveillance agency ANVISA requires certification as part of the requirements prior to granting registration. The marking obtained by this process is given by CGCRE – General Coordination for Accreditation of INMETRO (the National Institute of Metrology, Standardization and Industrial Quality) via accredited bodies. The INMETRO seal is mandatory and guarantees the quality, safety and efficacy of marketed products in the country.

MEET REGULATORY REQUIREMENTS FOR MEDICAL DEVICES

It is important to know that the reasoning for the certification process is intended primarily to inform and protect consumers, particularly with regard to health, safety and the environment. In addition, the product certification seeks to promote fair competition between the manufacturers and encourage continuous quality improvements in products. Globally, the certification provides adequate control with regards to international trade, while at the same time strengthening Brazil’s internal market.

HOW DOES ANVISA DEFINE MEDICAL DEVICES?

ANVISA defines medical devices as appliances, materials or accessories whose use or application is related to safeguarding individual or collective health, personal hygiene or cleanliness of surroundings; for diagnostic and analytical purposes; including cosmetic and perfume, as well as dietetic, optical, medical acoustic, odontology, and veterinary products.

Specifically:

• Diagnostic equipment

• Therapy equipment

• Medical-hospital support equipment

• Disposable materials and devices

• Implantable materials and devices (certification process not mandatory)

• Medical-hospital support materials and devices

• In-vitro diagnostic products (certification process not mandatory)

• Beauty and aesthetics devices

HOW DOES THE CERTIFICATION PROCESS WORKS?

Regulatory compliance

Medical devices intended for sale in Brazil must be prior approved by ANVISA and accredited by INMETRO via an approved certification body. ANVISA has developed a set of essential requirements for medical device compliance, similar to those in the EU, which gives two routes to ANVISA approval: i) Cadastre and ii) Registration.

Two routes to approval

i) Cadastre is for lower risk devices, and the simplest and quickest route to approval.

ii) Registration is a more complex process

Cadastre and Registration require similar documentation during the approval process.

APPROVAL PROCESS FOR CADASTRE AND REGISTRATION

The following steps are required to follow:

• Step 1 Conduct an ANVISA Good Manufacturing Practice (GMP) audit. The GMP audit is performed directly by ANVISA and must be done before the registration submission, because the GMP certificate issued is a pre-requirement for the registration submission for products class III, IV and some products class I and II (according to the Brazilian regulations). It is necessary to classify the product for registration first to determine if GMP will be required or not.

• Step 2 Electromedical devices covered by any standard included in the Normative Instruction No3 issued by ANVISA must be certified by an INMETRO accredited ‘Organization of Certification of Product’ and display the INMETRO mark.

This process includes:

• Initial factory inspection against ISO 13485 plus additional requirements of ORD 350

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Please Note:

Brazil uses international standards to guide their rules; however, these naturally undergo an adaptation to local requirements. Regarding the transition to the third edition of the series of standards IEC60601-x there is a large commitment from all sectors involved. It is expected that from 2014 the third edition of the series of standards IEC60601-x will be mandatory.

• Product testing of all INMETRO marked goods conducted by IEC accredited laboratories (accredited by a member of ILAC, IAAC or EA)

• Product test reports must be no more than two years old for initial certification and repeated at renewal, if the test reports are older than five years

• Annual surveillance inspections based on ISO 13485 and ORD 350 requirements to ensure standards continue to be met

• Step 3 Technical documentation is submitted to ANVISA.

• Step 4 Approval achieved.

OTHER REQUIREMENTS IN ADDITION TO THE APPROVAL PROCESS

• Import controls

Customs agents check medical devices transported to Brazil against the ANVISA database. This is to ensure all medical devices comply with the registration requirements before they are allowed entry into the country.

• Local representation

To sell your products in Brazil you must meet the ANIVSA approval requirements and have a local representative within Brazil who can act on your behalf in all product-related matters.

FURTHER INFORMATION

SGS has more than 70 years experience in the Brazilian market. As an accredited INMETRO certification body, we offer an unrivalled expertise in facilitating market approval for electrical and electronic products classed as medical devices.

Contact medicaldevices@sgs.com today to see how we can help your business.

P. 4MAY • 2013MEDICAL DEVICES NEWS

SGS MEDICAL DEVICES WEBINARSSGS has two complimentary webinars now available for playback on the latest developments in the medical devices industry. These webinars are part of the SGS service to keep manufacturers up to date with changes in the regulatory framework. Read on to find out the full details and links for each webinar.

WEBINAR ONE: PREPARING FOR THE NEW CHANGES IN NOTIFIED BODY AUDITS AND TECHNICAL FILE REVIEWS

The objective of this 45-minute complimentary webinar is to inform manufacturers of the likely changes they will start to experience in audits and technical documentation reviews from Notified Bodies. These changes, started in 2012, will continue to be introduced during 2013.

These changes are not those that will be introduced by the revision of the medical device directives but the more immediate tightening of conformity assessment following the PIP breast implant scandal and acknowledgement that Notified Bodies and certification bodies are not operating to the same standard.

The influence of the EC Commission, the Notified Bodies Code of Conduct and the IAF Mandatory Guidance MD 9 will be discussed. The actions that manufacturers should take to prepare for these changes will also be covered.

Topics

The webinar covers five topics:

1. Why is change needed?

2. Where and how are these changes being agreed?

3. Changes to audits and actions for manufacturers

4. Changes to technical file reviews and actions for manufacturers

5. Opportunity for Q&A

P. 5N° X • XXXXXXXX 2008XXX P. 5MAYY • 2013

SGS MEDICAL TECHNOLOGY SYMPOSIUM 2013

MEDICAL DEVICES NEWS

SGS Germany is hosting the annual ‘SGS Medical Technology Symposium’ event at its Munich branch on June 20, 2013.

The proposed symposium agenda includes presentations by several guest speakers from the medical devices industry including experts from Siemens, SGS and the University of Applied Sciences (Münster), who will be discussing current and internationally related topics. This one-day SGS event concludes with a comprehensive tour of SGS’ state-of-the-art testing lab in Munich.

SYMPOSIUM EVENT PRESENTATIONS

The following presentations are being held in Munich:

1. National Approval Process

• The CB process

• National approval requirements (practical examples: USA, Brazil and Russia

Speakers: Armin Hudetz and Thomas Mencke, SGS Germany GmbH

2. Electrical Product Safety in the Field of Medical Technology

Speaker: SGS

3. EMC Requirements for Electrical Medical Devices/Systems

• Changes expected to the new edition of EN 60601-1-2

Speaker: Robert Sitzman, Siemens AG

4. The Usability of Medical Devices, In-vitro Diagnostics and Laboratory Equipment

Speaker: The University of Applied Sciences Münster

5. RoHS – Requirements for Medical Devices

Speaker: Steffen Heycke, SGS Germany GmbH

FURTHER INFORMATION

• Event language: German

• Event timing: From 10:00 to 16:30 on June 20, 2013

• Event location: SGS Munich branch office (Hofmannstraße 50, 81379 München)

EVENT REGISTRATION

To register for this event please email: anita.sperlich@sgs.com

Contact medicaldevices@sgs.com today to see how we can help your business.

P. 6MAY • 2013MEDICAL DEVICES NEWS

MEDICAL DEVICES SYMPOSIUM 2013: SGS SHARES EXPERTISE IN MEDICAL DEVICE REGULATIONS IN JAPAN, KOREA AND TAIWAN

In April, SGS experts met with the Medical Devices industry and influencers in Japan, Korea and Taiwan to share the latest updates on medical device regulations. Education, we believe, is the key to successfully navigating the complexities of medical device regulations. Whether it is Chinese regulators easing market approvals via an online system, the EU and US FDA draft proposals for tightening of pre- and post-market surveillance respectively, or registrations in Russia being temporarily suspended – our focus is keeping you up-to-date, wherever in the world you operate.

KEEPING UP WITH CHANGE

Medical devices is one of the world’s fastest growing industries. We realize that staying up-to-date on how to gain market access in specific regions, and other key global markets, is crucial to manufacturers. With this in mind, we have created a comprehensive white paper outlining the market entry requirements and regulatory frameworks of 13 individual regions in a simple and easy to understand manner.

GLOBAL INFORMATION

As part of bringing this message to a global audience, SGS’ international team of medical devices experts travelled to Japan, Korea and Taiwan for a series of three educational events. The trip allowed us to connect directly with 350 delegates and discuss the challenges faced by manufacturers and other organisations in the medical devices supply chain. Topics ranged from specific market regulatory requirements for Russia, China, Saudi Arabia, the

European Union, Japan, Taiwan, Brazil, the US and Canada; through to seminars on the Asian Harmonisation Working Party (AHWP), the International Medical Device Regulators Forum (IMDRF), life-cycle management related to medical devices software and the introduction of the EN 62304, and the clinical evaluation of medical devices.

SUCCESSFUL SYMPOSIA

The symposia proved very popular and offered the chance to exchange information in a relaxed and interactive environment. The delegates remarked on the scope, depth and relevance of the topics covered. For the future, we were asked by delegates to continue making available any new changes in medical device regulations. Our team are already working hard to make sure this successful first step is just the beginning of long-term education program from SGS.

FURTHER INFORMATION

To download the SGS white paper mentioned in this article please visit the White Paper Library.

Contact the Medical Devices Team today to see how we can help your business. Kindly click on the “Email Us” link on this page.

P. 7N° X • XXXXXXXX 2008XXX P. 7MAY • 2013MEDICAL DEVICES NEWS

Target audience

This webinar is aimed at medical device manufacturers and organisations who have certification under one of the European medical device directives or who plan to obtain such certification. The relevant directives are Active Implantable Medical Devices, 93/42/EEC Medical devices and 98/79/EC In Vitro Diagnostic Medical Devices. The webinar topic is relevant for anyone involved with or responsible for quality systems, regulatory affairs, product design, manufacture or clinical activities.

Presenter

Mr. Chris Jepson BSc., FCQI, MIMMM, C Eng SGS Global Manager- Medical Devices

Mr. Jepson manages the SGS global medical devices activities and is currently Chair of NB MED, the forum of Medical Device Notified Bodies, Industry, EC Commission and other interested parties. In this role, he is involved with the ongoing European discussions on changes to current Notified Body policy and the future revisions to the medical device directives. He is a chartered materials engineer and fellow of the Chartered Quality Institute.

Webinar link

Please find the recording of the webinar by following this link:

https://sgseventcenter.webex.com/sgseventcenter/lsr.php?AT=pb&SP=EC&rID=51421987&rKey=2C60C91E80F6FC82

WEBINAR TWO: HOW TO UNDERTAKE AND DOCUMENT A CLINICAL EVALUATION

The objective of this one-hour complimentary webinar is to inform manufacturers of current challenges in meeting the needs of Annex X of 93/42/EEC, and utilisation of European Commission guidance to address requirements.

The impact of the recent high profile issue with metal-on-metal hip replacements has highlighted the need for robust clinical evaluations to be performed, and Competent Authorities are focusing on the clinical evaluation process and vigilance.

The basic requirements set out within Annex X of the directive will be discussed, and using MEDDEV guidance best practices will be described, addressing pre and post CE marking clinical activities.

Topics

The webinar covers five topics:

1. Essential requirements and Annex X

2. Current issues identified with clinical evaluations

3. Pre CE marking requirements for clinical evaluation

4. Post market clinical follow-up activities

5. Opportunity for Q&A

Target audience

This webinar is aimed at medical device manufacturers and organisations who have certification under one of the European medical device directives or who plan to obtain such certification. The relevant directives are 90/385/EEC Active Implantable Medical Devices and 93/42/EEC Medical Devices. Those people involved with or responsible for quality systems, regulatory affairs, product design, manufacture or clinical activities will find the subject relevant.

Presenter

Mr. Adrian Keene, SGS Clinical Affairs and Regulatory Manager.

Adrian Keene has responsibility for conformity assessment activities of all high-risk (class III) devices under the Medical Device Directive for SGS. He has over 19 years experience in the medical device industry, and previously held the role of Technical Manager – Medical Devices at the UK Notified Body LRQA. Prior to that, he worked

in the medical device industry, most recently in the areas of product safety and risk management. He joined the medical devices industry following postgraduate research and an honours degree in Toxicology and Pharmacology. He also holds a Diploma in Managing Medical Product Innovation from the Scandinavian International Management Institute. Adrian is a UK expert for ISO/TC 194 (Biological Evaluation of Medical Devices), and is an active participant in the forum of Medical Device Notified Bodies, NB-MED.

Webinar link

Please find the recording of the webinar by following this link:

https://sgseventcenter.webex.com/sgseventcenter/lsr.php?AT=pb&SP=EC&rID=53567412&rKey=62E5318F50A25E6B

Further Information

SGS webinars are part of the our on-going commitment service to keep manufacturers up to date with changes in the regulatory framework, contact us for more information on up coming webinars and how to register.

Contact medicaldevices@sgs.com today to see how we can help your business.

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