Indian electronics and system design companies are presented
with one of the best opportunity now in 2013 to enter manufacturing.
Quality and compliance to international standard is important
aspect of manufacturing. Designing electronics products
such as embedded systems and other devices to meet various
international compliances involves applying standards in
the early stage of design. The below article by Kalyan Varma,
Country Manager (Products Business), TUV Rheinland India
highlights the Importance of Regulatory Compliance Testing
& Certification for export of electronic and embedded products.
For Embedded Products companies, the easiest approach to
increase their top line is to place an existing product
or product line in new markets, especially if the primary
markets economy is down. The biggest obstacle is complying
with foreign regulatory requirements.
Every country has a technical barrier, which is bureaucratically
controlled to protect the local market or to restrict imports
– such as duties, tariffs, technical requirements, licensing
and legal local representation to protect their own national
products from foreign counterparts. In the regulatory compliance
world these measures most often take form of proof of compliance
to existing technical requirements by way of obtaining a
country specific approval or certificate of conformity generally
issued by an authorised third party or government agency.
For example, In India we have the Bureau of Indian Standards
(BIS), which has implemented the standards for the Indian
region same as WIRELESS PLANNING & COORDINATION (WPC) for
Wireless Products. According to latest regulation 15 new
product categories need mandatory approval from Bureau of
Indian Standards (BIS) with effect from April 2013.
While there are challenging markets which are more difficult
to access than primary markets, they often represent lucrative
sales territories. Once that potential is confirmed for
a certain embedded product, manufacturer needs to prepare
and plan carefully before launching market access efforts.
10 things to know before preparing global market access:
1. Design for Compliance from the Start
While the product is still in development stage, the manufacturer
should decide the Intended use, Area of Application and
Target Market. Identifying technical specifications in the
design phase will help ensure that the product’s features
will match the requirements of the target country.
It’s important to find out the estimated lead time of the
international certification process—it often is several
months long—so the product’s launch schedule can be defined
based on that information. Regulatory certification lead
times often are overlooked when product launch schedules
are set up.
It is always necessary to keep in mind that Regulatory compliance
is also part of Design Process.
2. Know the Basics
The manufacturer or Design House needs to know the requirements
for a particular market and be prepared for them. For example,
certain documents such as photos and block diagrams are
required so often that an importer should have them available.
Translated manuals, special labelling, samples, or test
reports may or may not be required. Knowing these requirements
in advance will allow the company to address them simultaneously
with other tasks that precede international certification
applications as well as set aside funds to fulfil them.
Mandatory labelling indicates that the imported product
is certified and approved to be on the market. The form
and content vary broadly from country to country.
3. Leverage Existing Test Reports
The good news is that having decided on the target market
the manufacturer only needs to perform a core set of tests
on the products once and then use the resulting test reports
to apply for several international certifications. However,
some countries will not take test reports in place of product
testing. This is especially true in Asia where many countries
require in-country or country-specific testing.
As far as product safety compliance is concerned, most countries
will accept test reports to International Electrotechnical
Commission (IEC) standards. Majority of secondary countries
do not require product safety certifications for IT equipment.
Those that do generally will accept a Competent Body (CB)
report without further testing. Manufacturers will need
to ensure that the CB report covers all the target countries
and voltages.
To get the most out of the core testing and reports, the
compliance team needs to investigate the report requirements
of all the potential target countries. If the applicable
test standard happens to be an internationally harmonized
standard, companies should ask the testing laboratory to
indicate all applicable national deviations.
4. Importance of Pre Compliance Testing
We recommend manufacturers, especially embedded electronic
services, to have some amount of pre-evaluations, as the
amount of failure rate especially in EMC is very high. The
first time clearance is mostly 10-20%, as every product
will have a certain amount of fine tuning to be done. With
pre-evaluation, you can have a better chance of higher pass
percentage.
5. Product Series/Family Approvals
If a manufacturer has a product line with multiple models
listed as part of the same product family, he must inquire
if the target country will allow family approvals. The tolerance
between model differences varies greatly. It is always recommended
to take advice of a Regulatory Compliance authority to understand
the groupings in case of Product family certification.
6. Speak the Language
Although English has become the universal language of communications
in the world, it is not so when it comes to challenging
markets. Before launching the market access effort, manufacturers
are well advised to inquire if a target country poses any
special language requirements. Having translated manuals
and safety instructions in the native language of the country
will save time during a certification process. Manufacturers
also can speed things along by building a relationship with
a translation agency, especially if only a handful of companies
can provide translation services to a specific language,
such as traditional Chinese, Russian, and Croatian.
7. Be on Time
The certification process will go much faster and smoother
if the manufacturer provides all requested documentation
on time. The project cannot start until all required information,
documents, and samples are provided. Most items can be prepared
prior to the start of certification even though some additional
items may be requested during the process.
Manufacturers also should be prepared for vastly different
lead times between different markets. Two countries may
border each other and require the same application materials,
and yet one authority will grant product approval in two
weeks while the other will take 12 to 14 weeks.
8. Play by the Rules
Market access requirements are meant to serve as a barrier
to foreign products, protecting local manufacturers. The
certification requirements are set by government agencies
and can be very bureaucratic. The best thing you can do
to speed up the approval process when working with government
organizations is to provide everything they ask. There is
little to no room for flexibility in changing the application
forms, authorization forms, and declarations.
9. The Importance of Shipping
The manufacturer may encounter some of the biggest hurdles
when sending samples for in-country testing to places such
as China or Brazil. Countries imposing in-country testing
requirements usually have strict customs regulations as
well.
Even if a company is working with an independent testing
laboratory on the approval, laboratories are not experts
in shipping and customs clearance. The importer should ensure
that its shipping department or shipping agent is well versed
in the customs and shipping requirements and use only services
that have demonstrated success in shipping samples to a
particular country.
10. Choose the Right Compliance Partner
A competent compliance partner can provide the requirements
up-front, assist with core testing, and leverage its own
agreements for report acceptance with the foreign certification
bodies. This is important because various test laboratories
have different agreements and accreditations.
For some countries, testing in India can take the place
in-country testing as long as the laboratory has the right
accreditations and agreements in place. A trusted partner
can save significant research time and provide the added
value of project management, especially if the list of target
countries is significant.
Conclusion
Even though navigating the international playing field is
complicated, access to challenging markets can result in
high returns for manufacturers of electronic products. Generalizations
of certain regions’ test requirements can help importers
sketch a compliance roadmap. Companies can enter multiple
global markets smoothly with plenty of advance research,
preparation and knowledgeable compliance, and shipping partners
on their team.
Kalyan Varma joined TÜV Rheinland India in 2000 and currently
is the Country Head for Products Business Stream. Kalyan
is a Technical Certifier for IT Equipment, Electro Medical
Devices and EMC, Auditor for Medical Device and Qualified
technical reviewer. He can be reached at vkalyan@ind.tuv.com
Author: Srinivasa Reddy N
