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Visit: http://labgo.in/
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Understanding compulsory registration scheme of bisLabgo
CRS (Compulsory Registration Scheme) was introduced by Department of Electronics and Information Technology (DeitY – now MeitY) along with Bureau of Indian Standards (BIS) with an aim to safeguard consumer interest for various electronics, telecom and I.T. products.
Visit: http://labgo.in/
In-vitro diagnostic regulation overview as per FDA , including in-vitro defination , classification , examples , general control, special control , pre market notification , DeNovo classification , PMA , 510k or premarket notification , risk based classification
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
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Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
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NSF International and its role in Dietary supplements & Nutraceutical industr...SyedArshiya4
This presentation will allow the reader to know about NSF international its history, mission, NSF Mark, role in Dietary supplements and Nutraceutical industries. It also give information on testing, inspection, certification of products.
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CE marking and CE certification what is it why you need it who can apply
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Visit: http://www.meddevicecorp.com/
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- QMS subparts
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In this presentation, we will discuss about the procedure of importing goods, acquiring licenses, various types of licenses, import evidence, acquisition of foreign currency. WE will also discuss about the rules and restrictions of import and exports.
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2. PROCEDURE FOR GRANT AND OPERATION OF BIS LICENCE
UNDER FOREIGN MANUFACTURERS CERTIFICATION
SCHEME (FMCS)
•In this scheme, a licence to use the Certification Mark of the Bureau of
Indian Standards, called the Standard Mark, can be granted by BIS for any
product against an Indian Standard.
•The BIS licence is granted indicating location as the manufacturing
address at which the manufacturing takes place, final product is tested as
per the relevant Indian Standards and conforming product is applied with
the BIS Standard Mark.
• The liability of non-conformance of the Standard Marked product, if any,
solely rests with the manufacturer. The role of the Bureau, as the third-
party certification agency, is limited to supplementing information to
consumers that the product has been manufactured under a well-defined
system of inspection and testing to establish its conformity to the
corresponding Indian Standard.
3. •“Manufacturer” means a business enterprise engaged in the manufacture of
any article or process, situated at a stated location or locations, that carries
out and controls such stages in the manufacture, assessment, handling or
storage of a product, that enables it to accept responsibility for continued
compliance of the product with the relevant Indian Standard and
undertakes all obligations in that connection, with regard to grant of BIS
licence to foreign manufacturer, under the Scheme.
•Through its surveillance operations, BIS maintains a close vigil on the
quality of products certified.
PROCEDURE FOR GRANT AND OPERATION OF BIS LICENCE
UNDER FOREIGN MANUFACTURERS CERTIFICATION
SCHEME (FMCS)
4. The foreign manufacturer shall set up a liaison / branch office located in India
with the permission of Reserve Bank of India, which shall meet all liabilities with
respect to BIS Act, Rules and Regulations for purpose of the BIS licence.
The requirement to set up an office in India shall not apply if the foreign
manufacturer nominates a legally appointed Agent, located in India, who
declares his consent to be responsible for compliance to the provisions of the BIS
Act, 1986; Rules and Regulations framed there under, and terms & conditions of
the BIS licence, including agreement, undertakings, etc.
In case of any change in the address of such Liaison / Branch Office of the
foreign manufacturer or of its legally appointed Indian Agent, the foreign
manufacturer is required to obtain prior consent of BIS in that regard before
effecting such change of address.
The foreign manufacturer shall submit an undertaking to BIS that all the
liabilities with respect to ensuring compliance to the BIS Act, Rules and
Regulations
6. Those desirous of obtaining the BIS licenses shall have to apply to BIS in
the Application Form along with requisite Application Fee (Schedule of
Fee Structure).
Separate application is required to be submitted for each product / Indian
Standard.
At the time of submission of the application, the documents given in
the check list shall also be required to be attached.
7. THE APPLICANT SHOULD SATISFIES THE FOLLOWING CONDITIONS
a) Complete manufacturing facilities for the product are available in-house
in the applicant’s factory at the address indicated in the application form (else,
details of alternate arrangements made are to be provided);
b) Complete testing facilities for the product in accordance with the
relevant Indian Standard are available in-house in the applicant’s factory at the
address indicated in the application form (else, details of alternate
arrangements made are provided);
c) Competent testing personnel are permanently employed, who
understand the requirements of the relevant Indian Standards and are
competent to carry out tests for various characteristics as per the test methods
prescribed in the relevant Indian Standards;
8. THE APPLICANT SHOULD SATISFIES THE FOLLOWING CONDITIONS
d) The product conforms to the relevant Indian Standard (assessed after
testing of a sample of the product in the applicant’s in-house laboratory and
/ or in an accredited independent laboratory for all the requirements as per
relevant Indian Standard) and a copy of the test report(s), so generated,
is(are) attached with application;
e) Agrees to comply with requirements laid down in a document, called
“Scheme of Testing & Inspection (STI)”. This STI (different for different
Indian Standards) includes frequency of inspection and testing for various
characteristics of the Indian Standard, which, as a part of process control,
are required to be carried out by the licensee after the grant of BIS licence
and appropriate records maintained. Copies of STIs are available with BIS
and can be obtained at any time on request and / or at the time of
submission or recording of application or during the visits by BIS inspecting
officers, and
f) Undertakes to pay the requisite fee to BIS.
10. 1 The application submitted by the applicant to BIS will be scrutinized,
and if found to be complete in all respects, it will be recorded. If, on
scrutiny, the application is found to be incomplete, the applicant will be
informed accordingly.
2 After recording of the application, preliminary inspection shall be
carried out at the applicant’s manufacturing and testing address(es) by BIS
inspecting officer(s) or its agent.
3 The cost of preliminary inspection by BIS shall be borne by the
applicant, which shall include the cost to BIS of the man-days spent by BIS
officer(s), the expenditure towards travel, stay and per diem, as applicable
for the BIS officer(s) as per the relevant norms of the Bureau.
4 In case the preliminary inspection is carried out by an agent of BIS, the
fees shall be arranged directly between the applicant and the agent. The
applicant shall make early arrangements for inspection, including
facilitating issuance of visa to the inspecting officer(s).
11. 5 During the preliminary inspection, the competence of the applicant
will be checked in respect of:
a) availability of requisite in-house manufacturing and testing
facilities as per the relevant Indian Standard(s);
b) competence of permanently employed testing personnel; and
c) conformity of the product sample(s) to the relevant requirements
of the Indian Standard, when checked in the applicant’s factory during
the preliminary inspection.
6 Sample(s) shall be drawn for independent testing, which the applicant
has to deposit with the laboratory indicated by BIS inspecting officer(s) or
its agent. The cost of testing of the sample(s) shall be borne by the
applicant. The discretion to choose the laboratory shall rest solely with BIS.
13. 1 The BIS licence is granted in accordance with the Regulation 4 of the
BIS (Certification) Regulations, 1988. The BIS licence is granted to an
applicant, if:
a) the results of preliminary inspection carried out by BIS
officer(s) (see 2.5) are satisfactory,
b) the sample(s) drawn during the preliminary inspection for
independent testing are found conforming to the relevant Indian
Standard(s) for all the requirements, and
c) the applicant agrees to comply with requirements given in the
relevant STI,
d) the applicant agrees to pay the annual minimum marking fee
and the licence fee to BIS, and
e) the applicant agrees to enter into an Agreement with BIS for
due compliance of the terms and conditions of the licence as given in
Regulation 5 of the BIS (Certification) Regulations, 1988.
14. 2 Immediately after grant of the BIS licence, the licensee shall pay
annual minimum marking fee and annual licence fee to
BIS. Subsequently, the licensee is required to pay the marking fee,
quarterly, on the basis of the production covered under the Standard
Mark during the quarter, as per the accepted marking fee rates.
3 The BIS licence, so granted, shall be valid for one year.
16. The applicant shall enter into an Agreement with BIS for due
compliance of the terms and conditions of the licence, as given in the
BIS (Certification) Regulations, 1988. The Agreement between BIS
and the licensee / manufacturer shall include provision for fees,
nomination, rights and responsibilities of licensee, determination /
termination, indemnity, performance bank guarantee, non-renewal,
cancellation of licence, etc.
18. 1 Surveillance inspections, as per the provisions given in the BIS
(Certification) Regulations, 1988, shall be carried out by BIS or its
agent to assess the performance of operation of the licence by the
foreign BIS licensee. The cost of inspection by BIS shall be borne by
the licensee, which shall include the cost to BIS of the man-days
spent by BIS officer(s), the expenditure towards travel, stay and per
diem, as applicable for BIS officer(s) deputed for the surveillance
inspection as per the BIS (Terms and Conditions of Service of
Employees) Regulations, 2007.
2 If inspection is carried out by an Agent of BIS, the fees shall be
arranged directly between the licensee and the Agent.
19. 3 Sample(s) shall also be drawn during the surveillance inspection
for independent testing by BIS at its own laboratory and/or
laboratory(ies) recognized by it for ascertaining conformance of the
product to the relevant Indian Standard. The cost of testing of the
sample(s) shall be borne by BIS. However, in case of products for
which the cost of testing is high, the testing charges shall be borne by
the licensee. The decision in this regard shall rest solely with
BIS. Further, the discretion to choose the independent laboratory
shall also rest solely with BIS.
4 Sample(s) shall also be drawn by BIS from market during
operation of the licence. The cost of market samples, thus drawn,
shall be borne by BIS. The cost of testing of the sample(s) shall be
borne by BIS. However, in case of products for which the cost of
testing is high, the testing charges shall be borne by licensee. The
decision in this regard shall rest solely with BIS.
21. 1 Whenever a complaint is received against the Standard Marked
product of the licensee, the licensee shall carry out investigation as per
IS/ISO 10002 and take appropriate actions to redress the complaint under
intimation to BIS, which may include repair or free replacement of the
product. If the complainant is not satisfied with the redress and lodges
complaint with BIS, then BIS will carry out an investigation and the
findings of such investigation and the redress so decided by BIS shall be
binding on the licensee.
2 In the event of any damage caused by the products bearing the
Standard Mark, or claim being filed by the consumer against BIS Standard
Mark, entire liability arising out of such non- conforming product shall be
of the licensee and BIS shall not, in any manner, be responsible in such
cases.
23. 1 The initial validity period of the licence is one year. The licence may be
renewed for further period of one year or two years subject to its satisfactory
operation, as observed during the surveillance inspections, conformity of
factory and market samples to the relevant Indian Standard in independent
testing, satisfactory redress of consumer’s complaints, if any, etc.
2 The licensee shall apply to BIS on the Renewal Application Form along
with the renewal application fee, the annual licence fee (for one or two years
as applicable) and the Annual Minimum Marking Fee or the marking fees
calculated on unit rate basis, whichever is higher (less the amount already
paid as the quarterly fee) at least one month before the validity of the
licence. The production statement, on the basis of which the marking fee is
calculated, shall also be required to be got certified from a Chartered
Accountant.