BIS Certification For Foreign Manufacturer


Foreign Manufacturers Certification Scheme (FMCS) is a Scheme operated by the Bureau of Indian Standards since the year 2000 under Scheme-I of Schedule-II, BIS Act, 2016 and (Conformity Assessment) Regulations, 2018 for foreign manufacturers. This scheme enables the overseas applicants/manufacturers to use the standard mark, which is also called ISI Mark, to sell their products in India. The foreign manufacturer’s Certification Department (FMCD) is the only eligible authority that can grant manufacturing licenses to foreign manufacturers. The major motive of BIS for granting a Manufacturing certificate to Foreign manufacturers is that the public gets good quality, safe, reliable, and risk-free products.

BIS FMCS Certificate in India from the FMCD department is meant for the manufacturing units located overseas, and which will undergo for factory audit to determine whether the manufacturer is complying with all the necessary requirements illustrated by BIS. It is also mandatory for foreign applicants to nominate Authorized Indian Representative (AIR).


The documentation part under the FMCS BIS Certification scheme of BIS is quite simple as very recently BIS Online application system has been introduced to collect and maintain the records. Following are the essential documents, that must be available with the applicant before initiating the project:

Factory/company registration documents
Flow chart of manufacturing process
Manufacturing capabilities in-house and also outsourcing agreement of manufacturing operation, if applicable.
Adequate facilities for testing
Quality Control Parameters and their records
Quality Control Parameters and their records
BIS Certification Process for Foreign Manufacturer

Surveillance Inspection is carried out from time to time, and market samples are drawn out by the BIS in order to assess the performance of the foreign BIS licensee.


In case any complaint is received against the licensee's product, then an investigation will be carried out as per IS/ISO 10002, and immediate action will be taken to redress the complaints, such as free replacement or repair. In case of any damage, the entire liability will be borne by the licensee, and BIS will not be responsible for any damages or losses.

A BIS certified manufacturers license is valid for the time period of one year. It can be further renewed for subsequent years just by filing a renewal application form along with the prescribed fees, which should be certified by the Chartered accountant.


Every Foreign applicant/manufacturer shall have a branch office located in India which shall fulfil all the liabilities and obligations with respect to the BIS Act, 1986, and rules and regulations framed for the purpose of registration, on behalf of the foreign applicant. Foreign Manufacturers/companies need to appoint an Authorized Representative in India to represent their case and meet the terms with the regulations and registration purposes.

It is mandatory for the foreign applicants to nominate Authorized Indian Representative (AIR in India to get BIS License, and ISI Mark Certificate in case they don’t have a branch office in India. AIR as a local representative is responsible for submitting and managing the application for certification and is available to answer the questions. While nominating the AIR, the applicant should ensure the following points.

  1. AIR nominated by the foreign manufacturer should be an Indian resident
  2. AIR shall give his consent that he is responsible for compliance with the provisions of the Indian BIS act, Rules, Regulations, and Terms & Conditions given in the BIS License, Agreement, Undertaking or other documents executed on behalf of the foreign manufacturer in connection with grant and operation of the license.
  3. AIR can only represent one Foreign manufacturer at one time, and cannot represent other Foreign applicants as AIR.
  4. AIR(s) shall have no conflict of interest in their role as AIR with testing of a sample(s) in third-party laboratories.
  5. The minimum qualification for an AIR is a bachelor’s degree and knowledge of the provisions of the BIS Act, 2016, as well as rules and regulations.
  6. AIR’s name shall appear in the license documents.


  • 1259, Meerut Rd, Saddique Nagar, Ghaziabad, Uttar Pradesh 201001
  • 7503304082
  • [email protected]


View our 2020 Medical prospectus of brochure for an easy to read guide on all of the services offer.