BIS Authorisation for import is a crucial step for importers looking to enter the Indian market. This  ensures compliance with Indian quality standards as well as establishes credibility, builds consumer trust, and unlocks opportunities for business growth. 

a. Determine the applicable Indian standard for your product category and gather the necessary documentation, including technical specifications, test reports, and manufacturing details.

b. Submit product samples to BIS approved laboratory for testing. The samples are assessed for compliance with the specified Indian standards.

c. Prepare and submit the required documents, such as the application form, test reports, manufacturing license, and quality management system certificates etc. to the BIS office.

d. BIS may conduct a factory inspection to ensure that the manufacturing processes align with the specified standards.

e. If your product successfully meets the standards, BIS will issue the BIS certification, allowing you to import and sell your products in India.

ACE Consulting Engineers as a render expert services for BIS Certification and with utmost due diligence and always focus upon the longevity of applicant’s business.

Check your Product(s) under BIS Compulsory Certification :-

https://www.bis.gov.in/product-certification/products-under-compulsory-certification/scheme-ii-registration-scheme/

Check your Product(s) under BIS Mandatory Certification:-

https://www.bis.gov.in/product-certification/products-under-compulsory-certification/scheme-i-mark-scheme/

Check your Product(s) under BIS Footwear & Leather Goods :-

https://www.bis.gov.in/wp-content/uploads/2020/11/FootwearLeather-QualityControlOrder-2020-29October2020.pdf

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority for pharmaceuticals and medical devices in India. The CDSCO registration process for importing medical devices is designed to ensure that only safe and effective devices enter the Indian market.

The CDSCO authorisation process begins with the submission of an application by the importer to the CDSCO. The application includes detailed information about the medical device, such as its intended use, technical specifications, manufacturing processes, labelling, and instructions for use. 

The CDSCO thoroughly reviews the application, assessing the safety, efficacy, and quality of the device. This includes evaluating the compliance of the device with applicable Indian regulatory standards and guidelines.

During the registration process, the CDSCO may request additional information or documentation to support the evaluation. This may include clinical trial data, performance evaluations, or evidence of conformity to international standards. 

The CDSCO may also conduct on-site inspections of the manufacturing facilities to ensure compliance with good manufacturing practices (GMP) and quality control standards.

Once the CDSCO is satisfied with the evaluation and the device meets the necessary regulatory requirements, it grants a registration certificate to the importer. 

ACE Consulting Engineers  render expert services for Medical Device Registration and Import License Application under CDSCO with utmost due diligence and always focus upon the longevity of applicant’s business.

REFER THE BELOW LINK FOR MEDICAL DEVICE REGISTRATION RULES 

The bidder has to furnish documentary evidence in support of the Technical Evaluation Bid (i) Certificate from Chartered Engineer (ii) Details of Similar Works / Services in past 07 (seven) years and certification from a Chartered Engineer (iii) Details of Financial Capability of the bidder duly certified by Chartered Accountant (iv) Work Order, SOR, Completion Certificate all Notarized and duly certified by Chartered Engineer in proof of their meeting the criteria along with the bid to establish his experience and track-record for meeting Bid Evaluation Criteria.

To know Fair Market Value of Plant Machine & Equipment

As per the International Valuation Standards,    Market Value is the estimated amount for which an asset should exchange on the valuation date between a willing buyer and a willing seller in an arm’s length transaction, after proper marketing and where each party had acted knowledgeably, prudently and without compulsion.

Valuation for Impairment Loss

An impairment loss is the amount by which the carrying amount of an asset exceeds its recoverable amount. An impaired asset is a company's asset that has a market price less than the value listed on the company's balance sheet.

For Revaluation of Assets

In Revaluation model, the fair value of plant , machinery and equipment is measured and reliably carried , being its fair value at the date of the revaluation deducting any subsequent accumulated depreciation and impairment losses. Revaluations are usually  made with sufficient regularity to ensure that the carrying amount does not differ materially from that which would be determined using fair value at the end of the reporting period. 

Valuation for Transfer Pricing Audit Purpose

Transfer pricing refers to the methods for pricing transactions within the  enterprises under common ownership or control. Because of the potential for cross-border controlled transactions to distort taxable income, tax authorities in many countries can adjust intragroup transfer prices that differ from what would have been charged by unrelated enterprises dealing at arm’s length.

Valuation of Capital Goods viz machines and equipments are sought by the Tax Auditors to know the anticipated value of assets for the Transfer Pricing audit purpose.

Valuation for Insurance

Valuation of assets is required for fixing of sum insured under fire and engineering class of business insurance policy . The valuation is generally provided on either of the  two methods: Indemnity basis or Reinstatement value basis as per the conditions of insurance policy.

Valuation for Disposal of Plant and Machines

Asset disposal is the act of selling an asset usually a long term asset that has been depreciated over its useful life like production equipment. When companies dispose their equipments, it gains a salvage value or residual value which can be a gain or a loss per the books.

• Commissioning report for installed capital goods.

• Verification of commercial production records.

• Verification of working condition of machines as per FTP.

For Import of Second Hand Plants, Machinery and Spares

• Chartered Engineer Certificate in line with the Indian Foreign Trade Policy. 
• Physical verification of goods as per Customs Examination orders.
• Representation before Customs Department as and when required.
• Evaluation of Technical Compliance for meeting Customs clearance criteria.

For End Use Certification of Imported Machines

• Technical Opinion Reports for confirming the end use of capital goods.
• Evaluation Reports for selection of HSN /  CTH code as per Customs law.

For Re Import of Export Goods

• Assessment of faulty , defective , non-functional capital goods for the purpose of repairing or upgradation before export.
• Identity Establishment at the time of re import to prevent imposition of duplicate import duty as per Customs law.

For Export of Old & Used Capital Goods

• Evaluation of second hand capital goods before Export for Customs assessment.
• Ascertaining the Working Condition and Residual Life for qualifying country specific requirements.
• Conforming the guidelines of MOEF&CC on Hazardous or E-Waste.

For EPCG Scheme and Foreign Trade Policy

• Nexus certification of capital goods as per Appendix-5A
• End Use confirmation for Pre-Production , Production and Post Production stage.
• Verification of manufacturing process flow chart & justification of import.

For Installation and Commercial Production

• Commissioning report for installed capital goods.
• Verification of commercial production records.
• Verification of working condition of machines as per FTP.

For Useful Life under Company’s Act - 2013

• Evaluation of  Nature of assets , maintenance schedule, working hours of the unit for ascertaining useful life of the plant.
• Componentization Analysis for claiming accelerated depreciation.
• Opinion report  in support of Tax Audit for  IndAS-16 accounting standards to ensure the depreciation is in line with the actual usage of assets.
• Compliance in order to fairly reflect in the balance sheet and income statement.

For Govt. Subsidy & Incentive Schemes

• MSIPS , SPECS , PLI Schemes of Electronic Manufacturing
• PMKSY scheme of MOFPI

Date of start of commercial production.

Evaluation Report for the plant & machinery installed, the price is as per the market value and the same are being used for the manufacturing of products as applied and approved under SPECS.

Fair Valuation of  used / second hand / refurbished plant, machinery and equipment including for associated utilities and R&D, whether imported or domestically procured.

Residual Life Certification of  used / second hand / refurbished plant, machinery and equipment including for associated utilities and R&D.

Fair Valuation of tools, dies, moulds, jigs, fixtures including parts, accessories, components and spares thereof.

Fair Valuation for reasonableness cost of plant, machinery, equipment and associated utilities self-fabricated including certification of the material cost.

• Evaluation of  Nature of assets , maintenance schedule, working hours of the unit for ascertaining useful life of the plant.

• Componentization Analysis for claiming accelerated depreciation.

• Opinion report  in support of Tax Audit for  IndAS-16 accounting standards to ensure the depreciation is in line with the actual usage of assets.

• Compliance in order to fairly reflect in the balance sheet and income statement.

Naveen Arora-  a registered Patent Agent for Patents & Designs with Office of Controller General of Patents, Designs & Trade Marks.

Patent and Design Registration

Patent agent, being a person of expertise in a particular technical field has a strong understanding of the scientific and technical aspects of an invention.

Ace Consulting Engineers helps the applicant to secure his patent by critically contributing our technical skills and legal knowledge to respond to the rejection and queries from examiner. Our dedicated team of professionals render following services : -

• Chartered Engineer Certificate in line with the Indian Foreign Trade Policy.

• Physical verification of goods as per Customs Examination orders.

• Representation before Customs Department as and when required.

• Evaluation of Technical Compliance for meeting Customs clearance criteria.

• Nexus certification of capital goods as per Appendix-5A

• End Use confirmation for Pre-Production , Production and Post Production stage.

• Verification of manufacturing process flow chart & justification of import.

• Assessment of faulty , defective , non-functional capital goods for the purpose of repairing or upgradation before export.

• Identity Establishment at the time of re import to prevent imposition of duplicate import duty as per Customs law.

• Evaluation of second hand capital goods before Export for Customs assessment.
• Ascertaining the Working Condition and Residual Life for qualifying country specific requirements.

• Conforming the guidelines of MOEF&CC on Hazardous or E-Waste.

ACE team can support the EPR aspirants by rendering End -to-End solutions


About the EPR
Extended Producer Responsibility is an environmental protection strategy to reach an environmental objective of a decreased total environmental impact from a product, by making the manufacturer of the product responsible for the entire life cycle of the product and especially for the take-back, recycling, and final disposal of the product.

What is changing with EPR?
Extended Producer Responsibility is an environmental policy which has been recently introduced in India. EPR requires a producer to take responsibility for the entire lifecycle for the products that they put into the market, including their disposal.

The changes to EPR, which started from the year 2022, shifts the cost of collecting household or industrial waste from the taxpayer to the producer.

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority for pharmaceuticals and medical devices in India. The CDSCO registration process for importing medical devices is designed to ensure that only safe and effective devices enter the Indian market.

The CDSCO authorisation process begins with the submission of an application by the importer to the CDSCO. The application includes detailed information about the medical device, such as its intended use, technical specifications, manufacturing processes, labelling, and instructions for use.

The CDSCO thoroughly reviews the application, assessing the safety, efficacy, and quality of the device. This includes evaluating the compliance of the device with applicable Indian regulatory standards and guidelines.

BIS Authorisation for import is a crucial step for importers looking to enter the Indian market. This  ensures compliance with Indian quality standards as well as establishes credibility, builds consumer trust, and unlocks opportunities for business growth. 

a. Determine the applicable Indian standard for your product category and gather the necessary documentation, including technical specifications, test reports, and manufacturing details.

b. Submit product samples to BIS approved laboratory for testing. The samples are assessed for compliance with the specified Indian standards.

c. Prepare and submit the required documents, such as the application form, test reports, manufacturing license, and quality management system certificates etc. to the BIS office.

d. BIS may conduct a factory inspection to ensure that the manufacturing processes align with the specified standards.

e. If your product successfully meets the standards, BIS will issue the BIS certification, allowing you to import and sell your products in India.

ACE Consulting Engineers as a render expert services for BIS Certification and with utmost due diligence and always focus upon the longevity of applicant’s business.

Check your Product(s) under BIS Compulsory Certification :-

https://www.bis.gov.in/product-certification/products-under-compulsory-certification/scheme-ii-registration-scheme/

Check your Product(s) under BIS Mandatory Certification:-

https://www.bis.gov.in/product-certification/products-under-compulsory-certification/scheme-i-mark-scheme/

Check your Product(s) under BIS Footwear & Leather Goods :-

https://www.bis.gov.in/wp-content/uploads/2020/11/FootwearLeather-QualityControlOrder-2020-29October2020.pdf

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority for pharmaceuticals and medical devices in India. The CDSCO registration process for importing medical devices is designed to ensure that only safe and effective devices enter the Indian market.

The CDSCO authorisation process begins with the submission of an application by the importer to the CDSCO. The application includes detailed information about the medical device, such as its intended use, technical specifications, manufacturing processes, labelling, and instructions for use. 

The CDSCO thoroughly reviews the application, assessing the safety, efficacy, and quality of the device. This includes evaluating the compliance of the device with applicable Indian regulatory standards and guidelines.

During the registration process, the CDSCO may request additional information or documentation to support the evaluation. This may include clinical trial data, performance evaluations, or evidence of conformity to international standards. 

The CDSCO may also conduct on-site inspections of the manufacturing facilities to ensure compliance with good manufacturing practices (GMP) and quality control standards.

Once the CDSCO is satisfied with the evaluation and the device meets the necessary regulatory requirements, it grants a registration certificate to the importer. 

ACE Consulting Engineers  render expert services for Medical Device Registration and Import License Application under CDSCO with utmost due diligence and always focus upon the longevity of applicant’s business.

REFER THE BELOW LINK FOR MEDICAL DEVICE REGISTRATION RULES 

The bidder has to furnish documentary evidence in support of the Technical Evaluation Bid (i) Certificate from Chartered Engineer (ii) Details of Similar Works / Services in past 07 (seven) years and certification from a Chartered Engineer (iii) Details of Financial Capability of the bidder duly certified by Chartered Accountant (iv) Work Order, SOR, Completion Certificate all Notarized and duly certified by Chartered Engineer in proof of their meeting the criteria along with the bid to establish his experience and track-record for meeting Bid Evaluation Criteria.

To know Fair Market Value of Plant Machine & Equipment

As per the International Valuation Standards,    Market Value is the estimated amount for which an asset should exchange on the valuation date between a willing buyer and a willing seller in an arm’s length transaction, after proper marketing and where each party had acted knowledgeably, prudently and without compulsion.

Valuation for Impairment Loss

An impairment loss is the amount by which the carrying amount of an asset exceeds its recoverable amount. An impaired asset is a company's asset that has a market price less than the value listed on the company's balance sheet.

For Revaluation of Assets

In Revaluation model, the fair value of plant , machinery and equipment is measured and reliably carried , being its fair value at the date of the revaluation deducting any subsequent accumulated depreciation and impairment losses. Revaluations are usually  made with sufficient regularity to ensure that the carrying amount does not differ materially from that which would be determined using fair value at the end of the reporting period. 

Valuation for Transfer Pricing Audit Purpose

Transfer pricing refers to the methods for pricing transactions within the  enterprises under common ownership or control. Because of the potential for cross-border controlled transactions to distort taxable income, tax authorities in many countries can adjust intragroup transfer prices that differ from what would have been charged by unrelated enterprises dealing at arm’s length.

Valuation of Capital Goods viz machines and equipments are sought by the Tax Auditors to know the anticipated value of assets for the Transfer Pricing audit purpose.

Valuation for Insurance

Valuation of assets is required for fixing of sum insured under fire and engineering class of business insurance policy . The valuation is generally provided on either of the  two methods: Indemnity basis or Reinstatement value basis as per the conditions of insurance policy.

Valuation for Disposal of Plant and Machines

Asset disposal is the act of selling an asset usually a long term asset that has been depreciated over its useful life like production equipment. When companies dispose their equipments, it gains a salvage value or residual value which can be a gain or a loss per the books.

• Commissioning report for installed capital goods.

• Verification of commercial production records.

• Verification of working condition of machines as per FTP.

For Import of Second Hand Plants, Machinery and Spares

• Chartered Engineer Certificate in line with the Indian Foreign Trade Policy. 
• Physical verification of goods as per Customs Examination orders.
• Representation before Customs Department as and when required.
• Evaluation of Technical Compliance for meeting Customs clearance criteria.

For End Use Certification of Imported Machines

• Technical Opinion Reports for confirming the end use of capital goods.
• Evaluation Reports for selection of HSN /  CTH code as per Customs law.

For Re Import of Export Goods

• Assessment of faulty , defective , non-functional capital goods for the purpose of repairing or upgradation before export.
• Identity Establishment at the time of re import to prevent imposition of duplicate import duty as per Customs law.

For Export of Old & Used Capital Goods

• Evaluation of second hand capital goods before Export for Customs assessment.
• Ascertaining the Working Condition and Residual Life for qualifying country specific requirements.
• Conforming the guidelines of MOEF&CC on Hazardous or E-Waste.

For EPCG Scheme and Foreign Trade Policy

• Nexus certification of capital goods as per Appendix-5A
• End Use confirmation for Pre-Production , Production and Post Production stage.
• Verification of manufacturing process flow chart & justification of import.

For Installation and Commercial Production

• Commissioning report for installed capital goods.
• Verification of commercial production records.
• Verification of working condition of machines as per FTP.

For Useful Life under Company’s Act - 2013

• Evaluation of  Nature of assets , maintenance schedule, working hours of the unit for ascertaining useful life of the plant.
• Componentization Analysis for claiming accelerated depreciation.
• Opinion report  in support of Tax Audit for  IndAS-16 accounting standards to ensure the depreciation is in line with the actual usage of assets.
• Compliance in order to fairly reflect in the balance sheet and income statement.

For Govt. Subsidy & Incentive Schemes

• MSIPS , SPECS , PLI Schemes of Electronic Manufacturing
• PMKSY scheme of MOFPI

Date of start of commercial production.

Evaluation Report for the plant & machinery installed, the price is as per the market value and the same are being used for the manufacturing of products as applied and approved under SPECS.

Fair Valuation of  used / second hand / refurbished plant, machinery and equipment including for associated utilities and R&D, whether imported or domestically procured.

Residual Life Certification of  used / second hand / refurbished plant, machinery and equipment including for associated utilities and R&D.

Fair Valuation of tools, dies, moulds, jigs, fixtures including parts, accessories, components and spares thereof.

Fair Valuation for reasonableness cost of plant, machinery, equipment and associated utilities self-fabricated including certification of the material cost.

• Evaluation of  Nature of assets , maintenance schedule, working hours of the unit for ascertaining useful life of the plant.

• Componentization Analysis for claiming accelerated depreciation.

• Opinion report  in support of Tax Audit for  IndAS-16 accounting standards to ensure the depreciation is in line with the actual usage of assets.

• Compliance in order to fairly reflect in the balance sheet and income statement.

Naveen Arora-  a registered Patent Agent for Patents & Designs with Office of Controller General of Patents, Designs & Trade Marks.

Patent and Design Registration

Patent agent, being a person of expertise in a particular technical field has a strong understanding of the scientific and technical aspects of an invention.

Ace Consulting Engineers helps the applicant to secure his patent by critically contributing our technical skills and legal knowledge to respond to the rejection and queries from examiner. Our dedicated team of professionals render following services : -

• Chartered Engineer Certificate in line with the Indian Foreign Trade Policy.

• Physical verification of goods as per Customs Examination orders.

• Representation before Customs Department as and when required.

• Evaluation of Technical Compliance for meeting Customs clearance criteria.

• Nexus certification of capital goods as per Appendix-5A

• End Use confirmation for Pre-Production , Production and Post Production stage.

• Verification of manufacturing process flow chart & justification of import.

• Assessment of faulty , defective , non-functional capital goods for the purpose of repairing or upgradation before export.

• Identity Establishment at the time of re import to prevent imposition of duplicate import duty as per Customs law.

• Evaluation of second hand capital goods before Export for Customs assessment.
• Ascertaining the Working Condition and Residual Life for qualifying country specific requirements.

• Conforming the guidelines of MOEF&CC on Hazardous or E-Waste.

ACE team can support the EPR aspirants by rendering End -to-End solutions


About the EPRExtended Producer Responsibility is an environmental protection strategy to reach an environmental objective of a decreased total environmental impact from a product, by making the manufacturer of the product responsible for the entire life cycle of the product and especially for the take-back, recycling, and final disposal of the product.

What is changing with EPR?Extended Producer Responsibility is an environmental policy which has been recently introduced in India. EPR requires a producer to take responsibility for the entire lifecycle for the products that they put into the market, including their disposal.

The changes to EPR, which started from the year 2022, shifts the cost of collecting household or industrial waste from the taxpayer to the producer.

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority for pharmaceuticals and medical devices in India. The CDSCO registration process for importing medical devices is designed to ensure that only safe and effective devices enter the Indian market.

The CDSCO authorisation process begins with the submission of an application by the importer to the CDSCO. The application includes detailed information about the medical device, such as its intended use, technical specifications, manufacturing processes, labelling, and instructions for use.

The CDSCO thoroughly reviews the application, assessing the safety, efficacy, and quality of the device. This includes evaluating the compliance of the device with applicable Indian regulatory standards and guidelines.