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Our support with Indian BIS (Conformity Assessment) Regulations, 2018


Regulation in Brief

Regulation in Brief: Bureau of Indian Standards (BIS) is a national body in India. The BIS Act, 2016, Rules & Regulations is a means for providing a third-party guarantee of quality, safety, and reliability of products to the customer. Under BIS Act 2016, BIS Rules 2018 and BIS (Conformity Assessment) Regulations 2018, the provision for Grant of Licence (GoL) are addressed. It covers BIS license for both Domestic and Foreign manufactures for chemical products listed in Scheme I.

Domestic Manufacturer Certification – Under this scheme, licence is granted to Indian manufacturers for use of Standard Mark on a product that conforms to the Indian standard. The application shall be made in the Form-V as specified in BIS conformity assessment regulations 2018 – Scheme I. Application submission can be done online.

Foreign Manufacturers Certification Scheme (FMCS) – Under FMCS, licence is granted to a Foreign Manufacturer for use of Standard Mark on a product that conforms to an Indian Standard. Foreign applicant can also nominate an Indian Resident as an Authorized Indian Representative (AIR) while submitting the application. The application also requires manual submission.

Product list: Currently there are 27 chemicals listed under Scheme I as on 29th of June 2020 and more will be added to the list. Please contact us for latest updates including information on standards ( ISI numbers).

Via the following link you can access to the list of chemicals: INDIA BIS_REGULATION_LIST OF CHEMICALS

Authority: The licence is granted by Foreign Manufacturers Certification Department (FMCD) located at BIS Headquarters, New Delhi for FMCS and by Regional and Branch office in case of Domestic manufacturer.

Process for getting a BIS license

Domestic Manufacturer

Option 1 – The applicant may apply for grant of licence to the Bureau along with the required documents. A visit will be paid to the factory of the applicant for assessment of the manufacturing infrastructure, production process, quality control and testing capabilities, and the sample(s) will be drawn for testing in third party testing laboratory. The sample(s) may not be drawn in case the grant of licence is to be considered on the basis of factory testing only. Factory testing is permitted for products as listed at Annexure I. 

Timeline: Process of grant of licence is expected to be completed within 120 days, except for all India first case where it may take 180 days, from the date of receipt of the application provided the documentation, assessment of the unit and conformity of the product is established satisfactory at first instance during various stages.

Option 2 – The applicant may apply for grant of licence to the Bureau along with the required documents and conforming Test Report(s) of the product samples manufactured by the applicant and of raw material(s) (if applicable) issued by a third-party testing laboratory.

A visit will be paid to the factory of the applicant for assessment of the manufacturing infrastructure, production process, quality control and testing capabilities, and draw of samples for testing in the third-party testing laboratory. The test report of the sample(s) drawn during the factory visit will be used for review purposes.

Timeline: Process of grant of licence is expected to be completed within 30 days from the date of receipt of the application if factory visit is satisfactory and conformance of sample to the relevant Indian Standard(s) is established at the first instance.

Foreign Manufacturer

The manufacturers, which have their factory location outside India can apply with filled prescribed Application Form along with necessary documentation. They can also apply by nominating and Authorised Indian Representative (AIR) using prescribed Nomination Form. Ensure that application is complete. 

Submit duly filled-in and complete application along with requisite fees; documentation (in duplicate) and Nomination Form of AIR at FMCD, BIS Headquarters, New Delhi.

BIS will scrutinize the application and queries, if any, will be communicated by email. Visit will be paid to the factory location to carryout verification of manufacturing & testing infrastructure and draw of samples for independent testing. Case would be processed for grant of licence after receipt of satisfactory inspection report & independent test report(s) conforming to applicable Indian Standard(s).

Timeline: Timelines shall be approx. 6 months for grant of licence.

 

What documents are required?

For Domestic Manufacturer

  1. Application Form V
  2. A self-evaluation cum verification report in the proforma, as given in Annexure-II
  3. Details of Quality Control Personnel
  4. Calibration Certificates of Testing Equipment to be verified during the visit
  5. Copies of Test Certificates of Raw Material, as applicable
  6. Drawing of sample(s) of the Product and / or Components, as applicable
  7. Report of Hygienic Condition, if applicable
  8. Plant layout indicating the location of manufacturing area, storage area for raw material and finished product, testing laboratory etc.
  9. Location Plan of the factory
  10. For the tests which are permitted to be subcontracted and not available with the manufacturer, copy of the agreement or consent letter from the outside laboratory for which arrangement for sub-contracting is made
  11. Inspection and Test Plan proposed to be followed, if different from Scheme of Inspection and Testing of the Bureau
  12. Undertaking for long duration test as per the template attached as Annexure-III, wherever applicable.
  13. In case of option 2, undertaking, as per the template attached as Annexure-IV

For Foreign Manufacturer

  1. Main Application Form V – Download the Form (Basic details of factory & product category)
  2. ISI Application Fee – Download the Bank Details (Copy of Remittance / Payment Advice) 
  3. Copy of Test Report done within a month by internal laboratory (Indicating conformance of the product to relevant Indian Standard)
  4. Address Proof of the Manufacturing Unit (Factory License / Tax Registration copy mentioning the scope as manufacturer)
  5. Trade Mark Registration (TM Registration copy)
  6. Certificate from concerned regulatory agencies for manufacturing (If there is any)
  7. Drawing of the product (As applicable)
  8. Present Installed Capacity (Manufacturing)
  9. Raw Material Details (Name of component used – name of supplier – quality certification of component) 
  10. Details of Machines (Name of machine – make – capacity – number/quantity)
  11. Layout plan of factory (Floor & technical) 
  12. Details of Manufacturing Process (Process flow chart along with outsourcing details, if any)
  13. Nature of packing (Size/quantity of packaging, storage facility) 
  14. Details of Test Equipment’s (Name of equipment – Size – Quantity – Calibration Status & Date)
  15. Details of QC (Quality Control) Staff (Name of person, qualification, designation, year of experience) 
  16. Method of disposal of substandard product (After manufacturing) 
  17. Organizational Chart of Factory (Management list with name & designation in chart format) 
  18. Location Map of Factory (With indicating the distance from Airport & City Centre)
  19. Authorized Indian Representative / Indian Liaison Partner (Details of Indian Dealer / Indian Liaison Partner who will represent you in BIS) – We provide this service.

Our Support with India BIS Regulations ( Conformity assessment) Regulations, 2018

At REACHLaw we are happy to help both Indian manufacturing companies and  foreign companies to prepare and submit quality application to obtain BIS license and its maintenance.

For more details please contact us.