WE’ll GET yoU To NorTh AMEriCA ANd ThE World.TESTiNG loCAlly – CErTifyiNG GlobAlly.

GlobAl MArkET ACCESS

oNE SoUrCE for fAST, EffiCiENT CErTifiCATioN: CSA GroUp GETS yoU To NorTh AMEriCA ANd ThE World.

Selling your products to foreign markets can be a complex business. Benefit from CSA Group‘s multilingual teams of

specialists and detailed knowledge of foreign requirements.

With more than 90 years of experience, CSA Group is a leading testing and certification organization in Canada and

the USA. The American National Standards Institute (ANSI), the Occupational Safety and Health Administration

(OSHA) and the Standards Council of Canada (SCC) have accredited and recognized CSA Group as an official

testing and certification body. CSA Group is also a member and national CB Scheme certification body of the IEC

System for Conformity Testing and Certification of Electrotechnical Equipment and Components (IECEE).

The global network of CSA Group provides you with local, qualified testing and certification specialists, who will

work with you throughout the entire process.

• Detailed knowledge of foreign requirements

• Acceptance of CSA reports

• CB report as primary basis of acceptance

• Single inspection

• Multilingual services

• Language translations

If you want to export your electro-medical products to foreign markets, CSA Group offers you one-stop as well as

turnkey testing and certification services for global market access:

Argentina 'S' Mark

Brazil INMETRO

Mexico NOM-NYCE

North AmericaCCSAUS

Kenia KEBS

South Africa SABS

Saudi Arabia SASO

India ISI

CIS EAC

Israel SII

Russia GOST-R

North AmericaCCSAUS

China CCC

South Korea KC/KCC

Taiwan BSMI

Japan PSE

Australia C-Tick

Malaysia MS

Singapore PSB

Europe CE

Czech Republic ESC

YOUr BENEfITS:

• Compiling the YZB (Product registration Standards) based on product specification and GB standards

• CfDA documentation submission package is pre-reviewed by CSA Group

• CfDA test protocol is planned in collaboration with CSA Group engineer and CfDA-designated lab engineers

• facilitated witness testing at the client‘s facility without having to send samples to China

• Mandarin-speaking staff in CSA Group‘s Global Market Access Team

• CfDA testing and product IEC/CSA conformity testing can be arranged simultaneously

• Both the CfDA product testing and the registration process are managed by CSA Group‘s Global Market Access

Team, to ensure timely completion

Obtaining certification marks for electrical and electronic products in China can be a challenge for you as

an exporter, as the registration process is lengthy and complicated. One of the most important factors is that you need to specify a legal

representative in China for registration and all after-sales services. Also, a number of legal documents are required for submission and the

application package shall comply with the product registration standard. As for overseas medical devices, CfDA registration is needed and

type testing is issued by a CfDA-designated lab. By offering specialized technical and regulatory assistance to facilitate CfDA registration,

our Global Market Access Team makes the certification process easy for you.

Test report is completed

Manufacturer/ Applicant

CfdA reviews document package

CSA helps manufacturer to assemble the required CfdA

registration documents

yZb compiled by CSA Group and verified by CfdA-designated lab

CSA specialist discusses test plan with

CfdA-designatedlab engineer

CSA Group coordinates testing protocol

CSA Group pre-reviews the package of documents

registration agent submits the package to CfdA

assessment center

yes

No

CSA Group resolves/coordinates resolution

with client

CfdA issues registration

More information is

required

ChiNA

GlobAl MArkET ACCESS

YOUr BENEfITS:

• foreign manufacturer gets assistance in preparing supporting documentation

and technical files in Korean

• Logistical support for test samples is provided

As a foreign manufacturer, you need to take into consideration several important factors when certifying your

electrical and electronic products for South Korea. for instance, you need to appoint a local Korean agency in order to obtain KfDA approval.

Also, you have to comply with the Korean Good Importing Practice, which is in line with ISO 13485, and an office and test facility for

non-destructive testing is mandatory. As for the classes, class 2, 3 and 4 devices require KfDA approval. for class 1 devices, importers need

to submit the product notification to KfDA. In all cases, a product sample is required for performance testing. for complex medical devices,

our CSA Group engineers collaborate with the respective Korean lab to draft a test protocol, if required. Important for you to know is as well

that an IECEE CB report with Korean deviations is accepted. Our Global Market Access Team makes the certification process easy for you,

offering specialized technical and regulatory assistance to facilitate KfDA registration.

korEA

kfdA reviewstechnical files

kfdA issues product license

CSA Group specialist coordinates test

protocol with korean lab and resolves technical issues

Submits technicalfiles to kfdA

Submits productnotification to kfdA

koreanimporter

Classes 2, 3, 4

Class 1

Manufacturer/ Applicant

Additional testing completed in kfdA-

designated korean lab

In Brazil, certification bodies must be accredited by INMETrO (National Institute of Metrology, Standardization

and Industrial Quality) and the INMETrO mark is mandatory for medical devices, which also need to carry the certification mark of the certi-

fication authority. The INMETrO certificate is needed by each Brazilian importer to register the medical devices at ANVISA (National Health

Surveillance Agency) and as of September 01, 2011, ILAC reports shall be less than two years old. As Brazilian standards are based on the IEC

60601 series (International Electrotechnical Commission), CSA Group can tie your Brazilian certification program with other applications

like the CSA Mark, CB certification, CSA Group certification and CE marking. Our Global Market Access Team provides the knowledge and

guidance you need to certify your electrical and electronic products for Brazil.

YOUr BENEfITS:

• Initial and follow-up factory audit on behalf of Brazilian body is done by CSA Group

• redundant testing is eliminated, as we can provide technical assistance on the product testing in the initial stage

• Time- and cost-effective process

brAZil

CSA Group reviews and compiles documents

factory implements corrective action

iNMETro certificate is issued

CSA Group performs factory audit on behalf

of iNMETro body

review of documents by iNMETro-

certification body

CSA resolves/coordinates resolution with client

Auditsatisfactory?

Moreinformation is

required

No

No

yes

yes

Manufacturer/ Applicant

YOUr BENEfITS:

• receive up-to-date information on national requirements and solutions

• Assistance on clinical trials in russia based on new russian requirements

• Solution of technical issues on safety testing

• Identify the family group based on the technical product information

• review of documentation packages for russian federal Service (rOSDrAVNADZOr) submission

• russian MED specialists review the file as part of the new registration requirements.

There are three basic steps for the registration and sale of medical devices in russia, which you as a manufac-

turer need to take into consideration: medical registration, hygiene certification, GOST-r certification.

CSA Group‘s service enables you to obtain the GOST-r mark and meet relevant government regulations, as well as safety requirements for the

russian market. CSA Group identifies all the implications associated with the export of your medical device to russia and resolves all issues related

to the approval process before the product leaves your country.

Our Global Market Access Team provides technical assistance and supports in navigating through the registration process.

rUSSiA

CSA Group Europe Tel.: +49 69 509 571 555 E-Mail: csa.europe@csagroup.org www.csagroup.org