market access market access SEPT/07/OCT

market market access access sept/07/oCt 

www.us.tuv.com 

www.tuv.com 

Your KeYs to NatioNal aNd iNterNatioNal CompliaNCe 

The Wi-Fi 802.11n DraFT 2.0 

ProDucT cerTiFicaTion 

The righT call For Wireless TesTing 

The Inside View 2 

Overview From Our 

Telecom/EMC Division Manager 

Cover Story: 

Telecom 3 

Initiating Official Certification 

Testing On The Wi-Fi 802.11n 

Draft 2.0 Products 

Late-Breaking News 5 

Introducing New, 

User-Friendly Website 

Late-Breaking News 6 

Announcing The Monthly 

Customer Feedback 

Survey Winner 

Medical 7 

ISO 13485 Opens Global 

Marketplace For 

Medical Devices 

Medical 13 

Worldwide Market Access For 

Medical Device Manufacturers 

Seminar Information 

Product Safety 14 

Getting The Lead Out 

Product Safety 16 

The New EU Chemicals 

Policy Is Within REACH 

TÜVRheinland® 21 

Resources 

Tradeshows / Seminars

market access 

The Inside View 

Dear valued Customers, 

The Wi-Fi certification process has now achieved a new and 

unparalleled level of excellence with the emergence of the new 

802.11n draft 2.0 standard. Products compliant with this standard 

offer an improved Wi-Fi connection with up to double the range 

and five times the transmission speed. These new updates enable 

consumers to use the latest technology in multimedia applications 

without the constraints of more dated Wi-Fi systems. 

TüvRheinland ® recently met a challenging, yet equally rewarding 

deadline set by Wi-Fi to launch this new Wi-Fi CERTIFIED 802.11n 

Draft 2.0 Program and has succeeded in emerging as the first 

testing lab to offer the certification to one of the prime Wi-Fi member 

companies. In doing so, the worldwide certification agency was at 

the forefront of conducting all tests during the qualification phase 

at Wi-Fi labs in Santa Clara, CA. TüvRheinland ® provided Wi-Fi 

with the test engineers who had the most experience in conducting 

tests under previous test plans. The experts participated actively 

in finalizing the 802.11n draft 2.0 test plan to be ready in time for 

official testing. 

By leading all Authorized Test Labs (ATLs) in supporting Wi-Fi 

during the sensitive period of finalizing such an important test 

plan, TüvRheinland ® also gained the confidence of the “gold 

units” manufacturers who had their products selected to be the 

reference test bed equipment in the test plan. For this and other 

reasons, TüvRheinland ® was approached by many Wi-Fi member 

companies to conduct testing on their wireless products utilizing all 

tests in the 802.11n draft 2.0 test suite. 

The testing for one of the prime Wi-Fi member companies was 

conducted in two phases. The first is a pre-certification phase, where 

TüvRheinland ® has given its newly established test bed for 802.11n 

Draft 2.0. This was exclusively for this company’s usage during the 

time between Wi-Fi announcement of pre-qualification for ATLs and 

the official certification launch date. Consequently, the company 

was granted the unique chance to certify the first 802.11n Draft 2.0 

product that happened to be the first to its platinum customer, who 

pushed the certified products in the market soon after. 

In this issue of Market Access Dr. Farouk Zanaty, TüvRheinland ®’s 

Wireless Development Manager describes in technical terms the 

characteristics of the Wi-Fi CERTIFIED 802.11n Draft 2.0 testing 

and the advantages of 802.11n over the previous 802.11b and 802.11a 

technologies. His article also focuses on TüvRheinland®’s services 

as an authorized Wi-Fi test lab for all official test plans. Also, you 

will find an article covering the ISO 13485 regulatory standard 

and another on removing the deadly neurotoxin found in toys and 

jewelry, as well as a piece on the REACH (Restriction, Evaluation, 

Authorization of Chemicals) system. You’ll get to discover about 

timely news items, such as TüvRheinland ®’s new North American 

website at www.us.tuv.com, customer feedback contest winners 

and more. 

Sincerely, 

Dana Craig 

Telecom/EMC Division Manager 

sept/07/oCt 

Dana Craig 

TELECOM/EMC DIvISION MANAGER 

TüvRheinland ® 

Mission Statement: To provide our clients with a valuable service that 

exceeds their quality and efficiency expectation by consistently improving 

our processes, ensuring the highest level of technical expertise while 

maintaining our position at the forefront of industry advancements. 

2


Cover Story 

TELECOM 

Authorized Test Laboratory (ATL), TüvRheinland®, has 

been qualified by the Wi-Fi Alliance to conduct testing 

for the Wi-Fi CERTIFIED 802.11n draft 2.0 program. 

TüvRheinland® has facilities in Silicon valley and 

Yokohama, Japan that can perform testing for 

the more than 300 members of the Wi-Fi Alliance. 

TüvRheinland®’s one-stop testing facilities assess 

all types of wireless devices, including laptops, 

wireless routers and switches, PDAs, voIP 

telephones, printers, computers, game stations and 

computer accessories. 

With this 802.11n testing, TüvRheinland® becomes 

one of the first labs qualified by the Wi-Fi Alliance 

to perform the testing. Consequently, the worldwide 

testing agency can help clients across the globe 

meet the huge market demand that exists for the 

certification program. 

With TüvRheinland®’s involvement to help launch 

the certification testing on time, Wi-Fi was able to 

advertise to the public that a wide range of Wi-Fi 

CERTIFIED 802.11n draft 2.0 products is expected to 

be available in time for back-to-school purchases. 

When Wi-Fi launched the interoperability 

certification for high-performance 802.11n draft 

2.0 products, TüvRheinland® was the leading 

certification lab to conduct the testing. The tests 

conducted at TüvRheinland® for 802.11n draft 2.0 


Initiating Official Certification Testing On The Wi-Fi 802.11n 

Draft 2.0 Products 

One-Stop Testing Facilities Assure Interoperability For Wireless Devices 

Authored by Dr. Farouk Zanaty (USA) Wireless Development Manager 

802.11 b 

802.11 g 

802.11 a 

802.11 n 

conTInUeD on pAge 4 

devices assure interoperability between these 

devices manufactured by different companies and 

utilize different wireless security protocols. 

The wireless transmission speeds for 802.11n draft 

2.0 products can be as much as five times faster 

than the previous generations of Wi-Fi products 

with an extended range that could be twice as fast. 

As part of conducting official tests according to the 

802.11n Draft 2.0 test plan, TüvRheinland® executes 

testing on the products to assure quality of service 

as mandated by the Wireless Multimedia (WMM) 

portion of the test plan. 

Prior to launching the certification testing program 

for 802.11n draft 2.0 products, TüvRheinland® was 

also instrumental in finalizing of the test plan. This 

led to more hands-on experience in working with 

the “gold units” of the participating companies 

and consequently showed the Wi-Fi community the 

higher level of competency that TüvRheinland® has 

over other testing labs. Also, TüvRheinland® has 

worked very closely with other software companies 

supporting the various tests in this latest test 

plan from Wi-Fi. In one instance, TüvRheinland® 

managed to acquire the pre-launch release of 

the WildPackets Omni product, which allowed 

test engineers to sniff and decode the wireless 

communications on the air, analyze all contents, and 

make pass/fail decisions. This allowed for invaluable 

hands-on experience, assuring that TüvRheinland® 

was ready for the Just In Time (JIT) certification 

testing tasks.


Cover Story 

TELECOM 

With this level of expertise and trust in the 

certification agency’s engineers, prominent Wi-Fi 

member companies have pre-qualified and tested 

their 802.11n draft 2.0 products at TüvRheinland® 

labs in Pleasanton, California. These companies have 

commended the TüvRheinland® test engineers who 

conducted all the challenging tests that led to official 

certification of the products under the new program. 

TüvRheinland® in Tokyo, Japan was also among the 

first accredited labs to conduct pre-testing and official 

certifications on the 802.11n draft 2.0 products. 

The certification testing for 802.11n draft 2.0 products 

is particularly important, because it contains testing 

for other legacy modes of wireless operations and 

includes all security and negative tests. The negative 

tests assure the rejection of wireless devices 

attempting to join the wireless network without the 

proper authentication. 

Comparing the wireless speed of 802.11n with 

previous categories of the 802.11 standards, it is by 

far the most efficient way of transferring wireless 

data. Table 1 shows the theoretical throughput values 

of the different standards. Having an 802.11n Access 

Point (AP) on a LAN segment that connects to the 

Internet would allow the efficient live communication 

in Infrastructure mode of all wireless clients (laptops 

with 802.11n client cards), as shown in Figure 1. Figure 2 

indicates the same efficient communications network 

is possible where the AP is replaced by one 802.11n 

client card in Ad-Hoc mode. If the same networks 

were constructed with 802.11b, 802.11g or 802.11a, 

the functionality will still be the same. However, the 

significant difference is the bandwidth available with 

using the 802.11n standard to make the networking 

exceedingly efficient. 


Initiating Official Certification Testing On The Wi-Fi 802.11n Draft 2.0 Products 

(continued) 

Ieee Standard 

802.11b 

802.11g 

802.11a 

802.11n 

Theoretical Throughput 

11 Mbps 

54 Mbps 

54 Mbps 

> 200 Mbps 

Table 1: Theoretical Throughputs of different 802.11 standards 

Figure 1: possible wireless network utilizing 801.11n Ap 

Infrastructure mode 

Figure 2: possible wireless network utilizing 802.11n wireless clients 

Ad-Hoc mode 

For more information, please call 1-TuV-rheinlanD 

(1-888-743-4652).


Late-Breaking News 

Introducing New, User-Friendly Website 

Online Presence Offers Enhanced Navigational Capabilities 


TüvRheinland® is pleased to announce the redesign 

of its new North America-orientated website at 

www.us.tuv.com. The recently launched site was 

designed with an updated look and feel that keeps 

the customers in mind. With enhanced navigational 

capabilities, visitors can easily find the data they 

seek in the most expeditious manner. Clients can now 

readily access compliance information by industry 

sector. 

Customers who wish to learn about all the different 

products and services that TüvRheinland® offers 

can either click on the products and services tab 

or change the global contact page that they wish 

to view. 

TUvdotCOM certificate holders can now input their 

identification numbers right from the homepage to gain 

access to the invaluable online database management 

system. Consumers can research different company’s 

marketing materials and compliance information by 

this method as well. 

Quote and information requests are still available 

online, so that TüvRheinland® can provide you with 

more detailed information. By clicking on the related 

links and filling out a simple online form, your specific 

request will be answered. TüvRheinland® hopes that 

you will view our new website at www.us.tuv.com and 

find the navigational capabilities to your benefit. 

If you have any questions, please call 

1-TuV-rheinlanD (1-888-743-4652).


Late-Breaking News 

Congratulations to Robert (Bob) Pardue from Hella 

Lighting Corporation – the August winner of 

TüvRheinland®’s customer feedback survey for the 

Management System Certification (MSC) Division. 

Bob is the proud winner of a high-quality gift that was 

sent to him recently, compliments of TüvRheinland®. 

Providing customer service is critical to the MSC 

Division. The customer feedback survey is given to all 

customers at the completion of their audit. This tool is 

used to identify the following key points in providing 

good customer service through: 

• Response time of services 

• Quality of services 

• Communications with staff 

• Technical competence 

• Level of knowledge 

• Level of courtesy 

• Overall impression 

• Professionalism of auditor 

If you are a quality customer, please take a few 

moments to respond to this mutually beneficial 

survey. Other vehicles of feedback are available 

to TüvRheinland® customers through an online 

feedback form available at www.us.tuv.com. 

For any certification, testing, or compliance questions, 

please call 1-TuV-rheinlanD (1-888-743-4652). 


Announcing The Monthly Customer Feedback Survey Winner 

Management System Certification Response Yields Valuable Prize For 

Lucky Contestant


Medical 



ISO 13485 Opens Global Marketplace For Medical Devices 

A Regulatory Standard That Assures The Implementation Of A Quality 

Management System 

Reprinted with permission, this article originally appeared on QualityDigest.com as “ISO 13485: A Path to the Global Market,” by Tamas 

Borsai (newtown, cT) Medical Division Manager, Brian Ludovico (Boxborough, MA) Senior Technical Manager and certification officer 

and gregor Dzialas (Boxborough, MA) FDA Third-party Audit program Manager and certification officer 

The medical device industry considers compliance 

with the European Union (EU)’s Medical Devices 

Directive a passport to the European market. Not to 

be overlooked, however, is the global appeal of ISO 

13485—“Medical devices—Quality management 

systems—Requirements for regulatory purposes.” 

Although ISO 13485 doesn’t take the place of the EU’s 

MDD, or those of other countries, this regulatory 

standard assures authorities that a manufacturer of 

medical devices has developed and implemented a 

quality management system. As companies expand 

into other markets, they find that ISO 13485 lends itself 

to conformance requirements across the globe. 

The 27 members of the European Union, Canada and 

Turkey all open their markets only to medical device 

manufacturers that have complied with ISO 13485. 

By comparison, the United States enforces its own 

national regulations regarding medical devices, as 

with the Food and Drug Administration’s CFR 21 Part 

820. These regulations share several similarities 

with ISO 13485’s quality system requirements. In 

fact, upon review, medical device regulations being 

implemented around the world contain many of the 

same requirements as ISO 13485. It stands to reason 

that ISO 13485 is a practical solution for those who 

plan to sell their products on the global market. 

The case for iso 13485 

Some manufacturers want an ISO 13485 certificate in 

hand as proof of their products’ quality. Others may 

choose to focus solely on obtaining a CE Mark (an 

EU safety-compliance mark that covers a variety of 

products, including medical devices) in an attempt 

to reduce time-to-market and eliminate redundant 

spending. Such an option can prove more costly than 

anticipated. As a regulatory standard, ISO 13485 can 

strategically position a manufacturer to adapt to new 

market requirements worldwide.


Medical 


ISO 13485 Opens Global Marketplace For Medical Devices (continued) 

Several manufacturers prefer to undergo ISO 13485 

certification well before they have a commercial 

product on the market. This strategy uses the 

formalized standard as a management tool to make 

sure that processes are under control from the 

beginning. For these companies, quality no longer 

becomes a promise but a fact ensured by their system 

and confirmed by an independent assessor. 

Having a quality management system at an early stage 

provides another advantage to these companies – 

quicker market access. Many regulatory organizations 

were involved in the development of this standard. 

Therefore, requirements in regulatory laws, such 

as the 93/42/EEC MDD, share numerous similarities 

with ISO 13485. Hence, after a simple update of their 

systems, these companies can quickly and costeffectively 

seek regulatory approvals from a variety of 

countries. 

For medical device manufacturers, it is missioncritical 

to receive such certification quickly. They 

invest in both research and development, as well as in 

the product’s sales and marketing plans. Particularly 


in the medical device industry, the longer a product 

languishes in the review process, the less it returns to 

the manufacturer’s bottom line. 

ISO 13485 certification is a strategic choice to help 

meet regulatory requirements within Canada, Japan, 

Europe, and Australia. The following represents a 

brief look at some of these regulatory programs and 

how they relate to ISO 13485. 

european union: MDD 

The approval and marketing of medical devices are 

regulated by three European Union directives: 

90/385/EEC Active Implantable Medical Devices, 

93/42/EEC Medical Devices Directive, and 98/79/EEC 

In vitro Diagnostic Devices. Each of these directives 

requires manufacturers to have a quality management 

system in place before a product can be released 

into a member’s market. Currently, these directives 

are under review for updates because they were 

implemented more than five years ago. 

A draft of the new revision for the MDD was published 

in 2005, and the expectation is that the European 

Union will implement it by the end of 2007. The most 

significant proposals concern conformity assessment, 

including: 

• Design documentation and design review 

• Clarification of the clinical evaluation 

requirements 

• Post-market surveillance 

• Compliance of custom-made device 

manufacturers 

• Alignment of the original MDD 93/ 42/EEC


Medical 

At this time, no changes to ISO 13485 are imminent. It is 

still a valid certification to hold even as changes to the 

MDD are being made. This standard outlines a quality 

system for the medical device industry and creates 

a map for manufacturers planning international 

distribution. In effect, ISO 13485 creates an easy-tounderstand 

blueprint to help implement and maintain 

a quality system. 

canadian Medical Devices regulations (cMDr) 

In 1998, the Food and Drugs Act was put into effect 

through the CMDR. Many of these regulations are 

similar to those of the United States and the European 

Union, such as mandatory reporting timelines for 

complaint handling. Under the CMDR, manufacturers 

are required to obtain device licenses for products 

that they intend to sell in the Canadian market. To 

apply for such a license, manufacturers must submit 

a copy of a quality management system certificate 

showing conformance to ISO 13485. 

To issue these quality management system 

certificates, the CMDR dictates that “persons” (i.e., 

registrars) must be recognized under the Canadian 

Medical Devices Conformity Assessment System 

(CMDCAS). When accredited under CMDCAS, 

these registrars ensure that the regulations are 

woven into the fabric of the manufacturer’s quality 

management system. 

Manufacturers often find value in the standard’s 

detailed explanation of how to maintain a 

management system. Because ISO 13485 is designed 

for regulatory purposes, it provides an effective 

conduit for implementing the device regulations. 

The acceptance and integration of ISO 13485 into 

regulatory requirements is seen throughout various 

memoranda of understanding between Canada 

and other regions, such as the European Union and 

Australia-New Zealand, creating a shorter path to 

global harmonization. 




Japan: Pharmaceutical affairs law (Pal) and 

Ministerial ordinance 169 

In recent years, Japan has updated its system 

for medical devices to account for the global 

harmonization of regulations and safety measures. 

In 2005, the PAL was revised, mandating that all 

medical device manufacturers receive approval 

before market entry. These changes mirror current 

regulatory approaches already in place in Europe 

and Canada. In fact, the Ministry of Health, Labor, and 

Welfare based Japan’s quality management systems 

requirements on ISO 13485 and outlined them in 

Ministerial Ordinance 169.


Medical 



In addition, by incorporating the guidance documents 

of the Global Harmonization Task Force (GHTF), 

Japan can harmonize its requirements and reduce 

some conflicting demands placed on manufacturers 

because of the variety of individual countries’ market 

entrance requirements, such as adverse event 

reporting, post-market surveillance, and auditing 

practices. The GHTF is a voluntary group composed 

of national medical device regulatory authority 

representatives from North America, Europe, and 

Asia-Pacific. The aim of GHTF is to encourage 

common practices while ensuring the safety and 

efficacy of medical devices. 

PAL regulation has a requirement for Class II, 

medium-risk devices (or so-called “controlled 

medical devices”) that parallels ISO 13485. For these 

products, a Registered Certification Body (RCB) must 

perform an on-site evaluation of the company. Some 

RCBs, like TüvRheinland®, are also accredited as 


notified bodies in the European Union or CMDCASrecognized 

registrars in Canada, making global 

access more convenient for manufacturers. For 

manufacturers simultaneously seeking approvals in 

Japan and the European Union, RCBs can perform a 

combined audit to meet both Ordinance 169 and ISO 

13485 requirements. 

australia new Zealand Therapeutic Product 

authority (anZTPa) 

In December 2003, Australia’s Therapeutics Goods 

Administration and New Zealand’s Medicines and 

Medical Devices Safety Authority (MEDSAFE) agreed 

to establish a joint regulatory scheme for therapeutic 

products. This trans-Tasman regulatory scheme is 

now overseen by the ANZTPA. The agency oversees 

the quality, safety, and effectiveness or performance 

of medical devices as it relates to the products’ 

manufacture, supply, import, export, and promotion. 

Currently, there are a number of medical-devicerelated 

international agreements between Australia’s 

Therapeutics Goods Administration and their 

counterparts in other countries. These include a 

Mutual Recognition Agreement with the European 

Union, Memoranda of Understanding with both 

Canada and Switzerland, and other agreements with 

countries such as Japan, China, and Malaysia. 

In addition, there is a limited agreement with 

the United States that currently does not include 

medical devices but is in the informal discussion 

phase. The existing Therapeutic Goods (Medical 

Devices) Amendment Act (2002) is modeled on the 

recommendations of the GHTF. 

10


Medical 

julY/07/august 


Under the current MoU with Canada, manufacturers 

located in Australia, New Zealand or Canada will be 

able to take advantage of similarities among their 

regulatory schemes for market access. Hence, it is 

anticipated that those medical device manufacturers 

that implement ISO 13485 will have a good starting 

position in this part of the world when the proposed 

regulations are passed. 

united states: Quality system regulations 21 

cFr Part 820 

ISO 13485 certification is not recognized under the 

FDA’s Food, Drug, and Cosmetic Act as sufficient 

evidence of compliance with U.S. Quality System 

Regulations (QSReg). However, QSReg 21 CFR Part 820 

does share many similarities with ISO 13485. In fact, 

compliance with ISO 13485 can help manufacturers 

maintain compliance with the U.S. QSReg. The 

parallels between both regulations were instrumental 

for the FDA’s Third Party Inspection Program, which 

was introduced by the Medical Device User Fee and 

Modernization Act of 2002. 

Under this program, eligible manufacturers of Class 

II and III medical devices can choose an FDAaccredited 

third party instead of an FDA official 

to perform inspections. The primary benefit of this 

voluntary program is to combine FDA inspections with 

other conformity assessment inspections to save time, 

money, and resources. 

Initially, 15 quality system registrars and notified bodies 

were accredited by the FDA to perform independent 

inspections. An accredited person can perform a 

side-by-side inspection to assess compliance with 

the MDD, ISO 13485, effective implementation of Part 

1 of the CMDR, and QSReg 21 CFR Part 820. 


Fortunately, this new worldwide third-party inspection 

was widely accepted by European accreditation 

bodies. They had previous experience with 

combination inspections because of agreements 

between the United States and Europe. However, the 

Canadian accreditor, Health Canada, saw a need to 

prove the validity of combination inspection to ensure 

the same level of confidence in the inspection results. 

11


Medical 

In September 2006, the United States and Canada 

established a Pilot Multipurpose Audit Program. 

In this pilot, qualified auditing organizations can 

perform a single inspection for both Health Canada 

and the FDA. PMAP evaluates the effectiveness of 

performing a single third-party inspection and/or audit 

of medical device manufacturers’ quality systems and 

gauges whether they meet the needs and regulatory 

requirements of both countries. 

This combined auditing and inspecting strategy 

accommodates the ever-increasing efforts in 

regulatory harmonization and incorporates quality 

system requirements found in both the QSReg and 

ISO 13485. 

iso 13485 certification process 

As global market access becomes paramount, 

manufacturers begin to focus more on a clear 

regulatory picture. A quality management system 

must incorporate a company’s processes to meet the 

requirements of ISO 13485. This enables an auditor 

to compare the standard’s requirements with the 

company’s standard operating procedures and actual 

performance of those procedures. 

Manufacturers considering ISO 13485 are recommended 

to contact a regulatory organization that 

has a wide scope of accreditation to better fulfill all 

regulatory needs. In some cases, it may also be helpful 

to have a consultant or in-house expert review 

and implement the requirements in preparation for a 

regulatory assessment. 

After a quality management system has been 

implemented, an auditor can perform an on-site 

audit, taking into account the various locations where 

quality system operations are performed, including 

the locations of critical subcontractors such as 

sterilization organizations and original equipment 



manufacturers. Auditing subcontractor sites is 

becoming more prevalent as outsourcing is used for 

cost-controlling measures. With objective evidence of 

the manufacturer’s compliance to both standard and 

regulatory requirements, the auditor can then give either 

a positive or negative recommendation for certification. 

Countries in North America, Europe, and Asia have 

differing sets of compliance rules. However, one 

common denominator can be found with ISO 13485. 

This standard is widely regarded as proof of a quality 

management system in the medical device industry. 

It outlines a set of processes and confirms a level of 

performance that validates a manufacturer’s quality 

management system. In markets worldwide, ISO 

13485 can therefore be considered a smart, fast, and 

cost-effective path to your next product launch. 

For more information, please call 1-TuV-rheinlanD 

(1-888-743-4652). 

12


Medical 

POSTAGE 

HERE 


Worldwide Market Access for Medical Device Manufacturers — 

Take Advantage of the Potential Opportunities Today 

The medical device 

marketplace is becoming 

more global. There are 

opportunities everywhere 

from Europe to North 

America and more. Do you 

know how to develope a 

global regulatory strategy 

that opportunities all 

market opportunities and is 

future proof? 

Topic Overview 

Day one 

October 15 - 16 — Villas of Grand Cypress Golf Resort, Orlando, FL 

October 18 - 19 — Handlerly Resort, San Diego, CA 

TÜVRheinland® a leader in global compliance solutions is presenting two separate 

two-day seminars to educate clients. Attend this seminar and take away: 

• A view of the global landscape 

• Regulatory requirements for different countries 

• Strategies to shorten time-to-market and optimize revenue potential 

Who should attend: 

Day 1: Regulatory Affairs Management • Marketing and New Product Development Professionals 

Day 2: Regulatory and Quality Engineers • Regulatory Compliance Professionals • Project and 

Product Management 

Registration Pricing: (including: breakfast, snacks and lunch) 

• One Day $750 • Two Day $1000 

Worldwide Market Access for Medical Device Manufacturers 

Seminar Information 

Day One 

Day Two 

introduction - The medical device market landscape 

Pal - The Japanese Pharmaceutical Introduction Affairs Law 

The medical device market landscape 

What Pal Means to You 

introduction 

Speakers 

current state of iec 60601 

iec 60601 (2005) 3rd edition - The sweeping new approach 

lunch 

PAL 

gaining access The to Japanese Turkey/ukraine/russia/india/roW 

Pharmaceutical Affairs Law 

to medical regulatory compliance 

lunch 

Tamas 

Borsai 

Title Here 

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general regulatory schemes 

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EU Regulatory Update 

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1-TuV–rheinland 1-888-743-4652 Break 

International 1-203-426-0888 

FDA Update 

Michael 

Brousseau 

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12 Commerce Road 

Newtown, CT 06470 

register online www.us.tuv.com 

Worldwide Market Access for Medical Device Manufacturers 

1


Product Safety 

Getting The Lead Out 

Testing to Ensure Lead-Free Consumer Products 

Authored by geoffrey Bock (USA) Manager RoHS/Weee Services 

Restricting hazardous substances in consumer 

products is no longer a “European” thing. U.S. 

Legislation already restricts lead in jewelry and some 

consumer products based on individual state bills. 

Some legislation is pending, while some is already in 

effect (please refer to the chart on pg. 15). 

Lead is desired for use within jewelry because of 

its ability to be easily formed and because it is also 

very inexpensive. However, mental and physical 

development, learning and attention disorders, 

neurological damage and even hearing problems can 

be traced to actual health disorders in children who 

are exposed to lead, which is a neurotoxin. 

Some states are going all out to ensure consumer 

safety. New York’s “A 5282 / S 4235 Lead-containing 

Novelty Consumer Products”-pending legislation 

includes novelty products such as practical jokes, 



figurines, adornments, eating and drinking utensils, 

toys, games, cards, jewelry (adult, children and bodypiercing), 

ornaments, yard statues, candles, holiday 

decorations, apparel and cosmetics. 

vermont, for example, goes beyond the norm by 

separating their legislation into two categories: 

• Children: Jewelry priced at $20 or less, toys, 

furniture, vitamins and other supplements, 

personal care products, clothing, food and food 

containers and packaging materials. 

• Other consumer products: Wheel weights, 

cosmetics, folk remedies, personal care products, 

tattoos, plumbing fixtures, non-residential paints 

and primers. 

Although some states differ from others in the 

enforcement implementation, one thing is clear. They 

aim to get the lead out! 

TüvRheinland® has an advantage in the global 

marketplace for testing consumer products 

and this legislation will add to the worldwide 

testing and certification agency’s many services. 

TüvRheinland®’s mobile lab can go onsite at 

consumer locations, retail outlets, shipping 

containers and even directly to the suppliers. The 

agency is even capable of analyzing an entire Dollar 

Store in just two days. 

1



Getting The Lead Out (continued) 

Lead and 

Other 

Substances 

california 

illinois 

indiana 

Maryland 

Maryland 

City of 

Baltimore 

Michigan 

(Pb) - Lead 

Michigan 

Toxic subst. 

Minnesota 

new York 

new York 

Vermont 

Children 

Vermont 

Consumer 

Restrictions 

lead in Jewelry 

Adult, Children & Body Piercing 

children’s Products 

jewelry, accessories, decorative objects, toys, 

candy, clothing & furniture 


jewelry, accessories, clothing, decorative objects, 

edible items, candy, food, dietary supplements, 

toys & furniture 





children’s Jewelry 

with metal components 





Toys 

containing or coated with a hazardous substance 

(including lead) 

Jewelry 

Adult, children and body-piercing 

novelty consumer Products 

such as:items for practical jokes, figurines, 

adornments, eating and drinking utensils, toys, 

games, cards, jewelry, ornaments, yard statues, 

candles, holiday decorations, apparel & cosmetics 

Jewelry 

Adult, children and body-piercing 


jewelry (priced at $20 or less), toys, furniture, 

vitamins and other supplements, personal care 

products, clothing, food and food containers 

including packaging 

other consumer Products 

including wheel weights, cosmetics, folk remedies, 

personal care products, tattoos, plumbing fixtures, 

non-residential paints and primers 

created by g. Bock 24 July 2007 

Requirements 

aB 1681 

Health & Safety Code 

Chap. 6.5 

hB 4853 

Lead Poisoning Act 

sB 102 

Lead Bearing Substances 

hB 1214 

Lead-containing Products 

Baltimore city health 

code 

hB 4132 

Lead Bearing Substances 

hB 4240 

Toxic Substances in 

Children’s Toys 

sF 1262 

Jewelry Products Containing 

Lead 

a 5282 / s 4235 

Lead-containing Novelty 

Consumer Products 

a 8077 / s 5784 

Jewelry-containing Lead 

s 152 

Prevention of Lead 

Poisoning by Exposure to 

Lead in Consumer Products 

s 152 

Prevention of Lead 

Poisoning by Exposure to 

Lead in Consumer Products 

Ask your local TüvRheinland® office how its team 

can be of assistance. Contact 1-TuV-rheinlanD 

(1-888-743-4652) or www.us.tuv.com today. 

Existing 

Legislation 

X 

X 

X 

Pending 

Legislation 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 


Date Effective 

Childrens’s Jewelry 1 Sept. 

2007 Other, 1 March 2008 

June 2006 

1 January 2008 

1 October 2007 

7 December 2006 

1 September 2007 

Introduced 

25 January 2007 

Introduced 

7 February 2007 

Introduced 

February 2007 

Introduced 


Introduced 

3 May 2007 

Introduced 


Introduced 28 February 

2007 

Maximum 

Concentration Values 

Depends on material class, 

typical ≤ 600 ppm and ≤ 

200 ppm 

≤ 600 ppm 

≤ 600 ppm 

≤ 600 ppm 

≤ 600 ppm≤ 1200 ppm 

≤ 600 ppm 

Depends on material class, 

typical ≤ 600 ppm and ≤ 

200 ppm 

≤ 600 ppm 

≤ 600 ppm 



The New EU Chemicals Policy Is Within REACH 


Ensuring A High Level Of Chemical Safety And Industry Competitiveness 

Authored by Scott Sagamang, (USA) product Safety Specialist 

Why implement a new eu chemicals policy? 

Prior EU legislation for chemical substances consisted 

of many different directives and regulations. Different 

rules for existing and new chemicals did not produce 

sufficient information about the effects of existing 

chemicals on human health and the environment. Risk 

assessment and risk management measures have 

typically been a slow process. 

Regulation (EC) 793/93 placed a distinction between 

the existing and new chemicals based on the cut off 

date of 1981. Chemicals that were reported as being 

on the European market between January 1, 1971 

and September 18, 1981 were called “existing.” The 


numbers of existing chemicals totaled over 100,000 

and were placed on a list called European Inventory of 

Existing Commercial Chemical Substances (EINECS). 

All chemicals that entered the market after 1981 were 

labeled as “new” chemicals. 

All new chemicals had to be tested before placement 

on the market. Existing chemicals did not have to meet 

the same provisions. Therefore, existing chemicals 

had limited information on the properties and uses, 

but the lack of sufficient data created difficulties for 

assessing and controlling the chemicals sufficiently. 

Risk assessment was the responsibility of the public 

authorities and contained only comprehensive 

information not use-specific. 

1



The New EU Chemicals Policy Is Within REACH (continued) 

What are the objectives of reach? 

A new strategy was published in 2001 (COM (2001) 

88). It outlined a new system to ensure a high level 

of chemical safety and competitiveness throughout 

industry called the REACH (Restriction, Evaluation, 

Authorization of Chemicals) system. 

The system outlined seven objectives: 

• Protection of human health and the environment 

• Maintenance and enhancement of the 

competitiveness of the EU chemical industry 

• Prevention of fragmentation of the internal market 

• Increased transparency 

• Integration with international efforts 

• Promotion of non-animal testing 

• Conformity with EU international obligations 

under the WTO 


Why will reach work? 


REACH will engage the industry to ensure that the 

chemicals manufactured and placed on the market will 

not adversely affect human health or the environment. 

Industry will be responsible for obtaining knowledge 

of the properties of substances and managing the 

potential risks. Therefore, authorities would then 

focus on ensuring the industry is meeting their 

obligations and taking action on substances of very 

high concern. 

REACH will be a single system to cover both existing 

and new chemical substances. The basic elements of 

REACH set by the European Council are: 

1. All substances are covered by the regulation 

unless explicitly exempted from its scope. 

2. Registration requires manufacturers and importers 

of chemicals to obtain relevant information on their 

substances and to use that data to manage them 

safely. 

3. To reduce testing on vertebrate animals, data 

sharing is required for studies on such animals. 

For other tests, data sharing is required on request. 

4. Better information on hazards and risks and how 

to manage them will be passed up and down the 

supply chain. 

5. Downstream users are brought into the system. 

6. Evaluation will be undertaken by the 

European Chemicals Agency to evaluate testing 

proposals made by industry or to check compliance 

with the registration requirements. The Agency 

will also coordinate substance evaluation by the 

authorities to investigate chemicals with perceived 

risks. This assessment may be used later to prepare 

proposals for restrictions or authorization. 

1




07. Substances of very high concern will be 

made subject to authorization. The agency 

will publish a list containing such candidate 

substances. Applicants will have to demonstrate 

that risks associated with uses of these 

substances are adequately controlled or that the 

socio-economic benefits of their uses outweigh 

the risks. Applicants must also determine if there 

are safer alternative substances or technologies 

that could be used. 

08. The restrictions will provide a procedure to 

regulate the manufacture, placing on the market 

or use of certain dangerous substances. They 

shall be subject to conditions or prohibited. The 

restrictions act as a safety net to manage risks 

that are not adequately controlled. 

09. The European Chemicals Agency will manage the 

technical, scientific and administrative aspects of 

the REACH system. 

10. A classification and labeling inventory of 

dangerous substances will help promote 

agreement within the industry on classification of 

a substance. 

11. A database will be established to provide access 

to chemical information. 



What are the established timelines to comply with 

the reach regulation? 

REACH entered into force on June 1, 2007 and 

registration responsibilities will begin June 1, 2008. 

Priority of registration will be based on tonnage 

manufactured or imported into the EU per year. Full 

registration will take place over the next 11 years. 

Pre-registration June 1, 2008 – 

November 30, 2008 

>1000 tonnes November 30, 2010 

Substances classified 

as R50/53 >100 tonnes 

CMRs >1 tonne 

>100 tonnes May 31, 2013 

>1 tonne May 31, 2018 

What should companies do to prepare? 

TüvRheinland® can assist you with the new regulation 

by offering the following services: 

Preparation for reach 

Before preparing for pre-registration, companies 

have to analyze the entrepreneurial decisions that 

are involved when it comes to actually registering 

substances and decide on the focus of the registration 

process. This step is very complex and extremely 

time-consuming. 

1




Our services: 

- In-house company preparation by means of 

sensitizing the different players 

- Building up a REACH project plan 

- Training of REACH compliance managers 

- Inventorying of the substances 

- Check of the registration necessity under 

REACH(Filtering) 

- Inventorying the required and available data 

- Missing data and cost analysis 

- Setting up a plan for communicating with 

customers and suppliers 

- Impact assessment to prepare for entrepreneurial 

decisions 

- Drawing up a laboratory timetable 

Our software SimREACH® simulates the new 

chemical directive by translating the entire directive 

into calculations. Its output is a data gap analysis and 

a cost estimation. SimREACH® takes into account and 

evaluates all the key economic aspects such as the 

profitability of the product portfolio, optimal consortia 

line-ups, financial requirements in the years ahead 

or amortization of the registration. Through this, 

SimREACH® allows your company to check whether 

their strategic decisions still make sense in the 

reference of the new legislation. 



Pre-registration services - 

REACH provides an extended time period for 

registration only for substances which have been 

pre-registered. This time period enables companies 

to spread the different registration tasks and costs 

over several years. 

Our services: 

- Representing your company during the pre- 

registration process 

- Pre-registration of all substances 

consortia management - 

SIEF (Substance Information Exchange Forum) 

facilitates data sharing between pre-registrants 

and helps to organize consortia. The aim is to avoid 

unnecessary testing on vertebrate animals and to 

reduce the financial burden of registrants. 

Our services: 

- Accompanying within SIEF 

- Preparation for consortia formation 

- Representing the companies in consortia. 

- Checking your consortia contracts 

- Checking the cost sharing model of your consortia 

membership 

- Checking the validity and nominal value of the 

offered study reports 

registration services - 

For the registration process the manufacturers and 

importers have to procure data for all chemicals and 

identify appropriate risk management measures and 

communicate them to the users. 

1




Our services: 

- Representing your company during the registration 

while keeping your anonymity 

- Regulatory support (for Chemical Safety Reports, 

MSDS, Preparation of dossier etc.) 

- Communication with the European Chemicals 

Agency in Helsinki (ECHA) 

- Laboratory support (for testing, toxicology, 

planning and realization of studies 

- Registration of substances 

- Submitting all the necessary registration 

documents via IUCLID 5 

authorization- 

The authorization procedure will require companies to 

switch progressively to safer alternative substances 

where a suitable alternative exists. 

Our services: 

- Checking the possibility of substitution of your 

substances 

- Implementing of risk management measures 

(control of the hazards) 

- Carrying out the socio economical analysis 

only representative: a specialty for companies from 

non-eu countries- 

To comply with REACH non-EU companies require 

a legal entity in Europe or a partner for registration 

with an office in the EU. This is a mandatory 

requirement in order to pre-register products, 

participate in consortia and be in the European 

market furthermore. TüvRheinland BioTech GmbH 

is offering to carry out the registration on behalf 

of non-European companies with all the rights and 

obligations involved: 


Our services: 

- Pre-Registration 

- Communication with ECHA 

- Accompanying within SIEF 

- Representation in consortia 

- Communication with Downstream Users 

(customers) 

- Documentation obligation 

- Management of registration 

- Registration payment 

- Regulatory support 

- Laboratory support 

- Drawing up and submitting all the necessary 

registration documents 

- Neutrality in handling your registration efforts 

are you missing something? 

If you have an additional request, we will find a solution! 

Find more about our services at 

www.tuv.com/reach or call 1-TuV-rheinlanD 

(1-888-743-4652). 

20


TÜVRheinland® Resources 


Assisting Your Company With Testing, Certification, 

Compliance & More 

Tradeshows 

To view other tradeshows that TüvRheinland ® will be 

visiting, please visit http://www.us.tuv.com/news/tradeshows.aspx. 

raPs 2007 

Regulatory Affairs Professionals Society 

Hynes Convention Center 

Boston, MA 

September 23-26 | Booth #316 

Quality expo 2007 

Donald E. Stephens Convention Center 

Rosemont, IL 


northern california Facilities expo 2007 

Santa Clara Convention Center 

Santa Clara, CA 


isa 2007 

Automation Conference, Training and Exhibition 

Reliant Center 

Houston, TX 

October 2-4 | Booth #1222 

neca 2007 

National Electrical Contractors Association 

Moscone Center 

San Francisco, CA 

October 6-8 | Booth #312 

ieee symposium on Product compliance engineering 2007 

Radisson Hotel & Conference Center 

Longmont, CO 

October 22-23 | Booth #TBA 

PcB Design conference east 2007 

Marriott Durham at the Civic Center 

Durham, NC 

October 23 | Booth #TBA 

rsna 2007 

Radiological Society of North America 

McCormick Place 

Chicago, IL 

November 25-30 | Booth #8946 

Seminars 

Please visit www.us.tuv.com/training/index.aspx for availability, 

cost and registration options. 

Weee/ rohs asia vs. europe Web seminar 

September 13, 2007 

October 18, 2007 

November 15, 2007 

December 13, 2007 

Medical Device Manufacturers seminar 

Creating a Global Regulatory Strategy 

October 15-16, 2007 

October 18-19, 2007 

(*Please refer to pg. 13 for more details.) 

21

1-TUV 

Rheinland 

ALWAYS ON CALL... 

TUV Rheinland of North America’s 

Call Center Answers All Your 

Compliance Needs 

Do you need to get your 

products to market faster? 

Call the TUV HOTLINE 

today at 1-TUV-RHEINLAND 

to speak with a trained specialist! 


1-TUV-RHEINLAND (1-888-743-4652)


Traci conroy Managing editor 

TüvRheinland ® 

12 Commerce Road, Newtown, CT 06470 USA 

Tel 203-426-0888 

Fax 203-426-4009 

Email tconroy@us.tuv.com 


Market Access is published six times a year by TüvRheinland ®. 

Subscriptions are free. This newsletter is published for the 

convenience of our customers, clients and professional 

associates. Although it is intended to provide accurate and 

authoritative information with respect to the subject matter 

covered, the information and opinions contained in this 

publication are those of the authors and not of the editor or 

publisher. The authors, editor and publisher disclaim any liability 

for any inaccuracies contained herein. Before any action is 

taken based upon the published information, it is essential that 

competent and individual professional advice is obtained. 

TÜVRheinland®, Inc. is an equal-opportunity/affirmative 

action employer.

market access market access SEPT/07/OCT

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