How Can Manufacturers Get BIS ISI Certification for Medical Equipment in India?

Even if a manufacturer of medical equipment has advanced technology, international approvals, and a great deal of experience, none of these facts ensure that access to the Indian market is obtained. When it comes to products that are covered by the mandatory Indian Standards, obtaining BIS ISI Certification becomes an important regulatory requirement before the product is manufactured, imported, or sold in India.

There is one important point that manufacturers should grasp: BIS ISI Certification for medical equipment is not a general necessity for all medical devices. For any given product, the ‘particular requirement’ would vary depending on the product, Indian Standards, applicable Quality Control Order (QCO), and relevant law applicable to that product. Additionally, Medical Devices Rules, 2017 (MDR 2017) govern the regulation of medical devices in India under the aegis of CDSCO. 

But how does one identify whether BIS ISI certification applies to the firm, be it an Indian or foreign firm, and the procedures therefrom? The article addresses the requirements, processes, necessary documentation, timeline, period of validity, and issues involved therein.

Is Any Medical Equipment BIS ISI Certification Needed?

While BIS certification is not mandatory in most cases, the Indian government has made it mandatory for certain products through its Quality Control Orders and other guidelines.

Products that are subject to such requirements must adhere to the relevant Indian Standard and display the required Standard Mark according to the appropriate BIS conformity-assessment scheme.

BIS now lists some Medical Equipment under Scheme I. Examples include:

The technical guidance for standards such as IS 3055 and IS 7620 is also given in the BIS product-specific information.

Hence, manufacturers ought to determine the specific product and the relevant Indian Standard before assuming that all medical devices need to have an ISI Mark.

BIS Certification vs CDSCO Approval: What Manufacturers Must Know

It is one of the most important distinctions in the field of compliance. The BIS ISI Certification relates to a specified product meeting the appropriate Indian Standard within the relevant BIS certification scheme.

In contrast, the CDSCO for medical devices pursuant to the Drugs & Cosmetics Act, 1940 and the Medical Devices Rules, 2017. The CDSCO says that all medical devices are brought within the scope of the MDR 2017, with the appropriate provisions and exemptions.

As a result, the manufacturer might have to meet both the BIS requirements and the medical-device regulatory requirements, depending on the product.

This means that product classification and regulatory mapping constitute the first practical stage in obtaining BIS Certification in India.

What Are the Basic Requirements for Obtaining BIS ISI Certification?

Manufacturers should check before they apply whether their facility and product are ready for certification.

The main requirements include:

• Applicable Indian Standard identification
• Product specifications matching the standard
• Required manufacturing infrastructure
• Quality-control and process-control systems
• Required testing equipment
• Competent testing personnel
• Product-specific Scheme of Inspection and Testing
• Suitable technical documentation
• Testing arrangements as prescribed
• Compliance with BIS marking requirements

The BIS also publishes product manuals and technical guidelines which include details on testing equipment, sampling, the scope of the product, and the Scheme of Inspection and Testing for specific standards.

Documents Required BIS ISI Certification for Medical Equipment

The precise documentation varies according to the product and the relevant Indian Standard; in the case of a typical application, it may be necessary to:

• Basic data of the manufacturing unit and the product segment
• Evidence of the manufacturing unit’s address (for example, a deed showing ownership or a utility bill, etc.)
• Trademark registration certificate (if brand name is used and registered)
• Manufacturing licence / statutory approvals (where relevant – such as pollution
• control and industry-specific approvals)
• Product drawings/design schematics
• Installed manufacturing capacity
• List of materials used and specifications
• Details of manufacturing machinery and equipment
• The layout plan of the factory, including production and testing areas, and storage areas
• A detailed manufacturing process flow is given
• In-house test equipment and calibration information
• Information about the quality control personnel
• Factory organizational chart

In the case of FMCS applications, BIS specifically mandates the nomination of an AIR together with all the relevant supporting documentation.

The BIS ISI Certification Process: From Application to Licence

The certification process can best be understood by referring to the following stages.

Step 1: Identify the Applicable Indian Standard

The first thing to do is to determine the Indian Standard (IS Code) that applies to the medical equipment.

Manufacturers should:

• Identify the applicable IS Code and certification scheme
• Understand the product requirements
• Align the product and manufacturing process with the standard

Step 2: Product Testing & Documentation

The product has to satisfy the relevant testing requirements, and the testing must be carried out in accordance with the specifications of BIS.

At this stage:

• Product samples are prepared for testing
• Technical documents are compiled
• Factory and manufacturing details are collected
• Required application documents are prepared

Step 3: BIS Application Submission

The manufacturer makes the BIS application via the relevant online system together with the necessary supporting documents and the fees.

Key requirements include:

• Test reports, where applicable
• Factory and product details
• Technical and quality-control documents
• Applicable government fees

The BIS then examines the application and the supporting information.

Step 4: BIS Factory Inspection

BIS officials may inspect the manufacturing facility to assess:

• Manufacturing processes
• Production facilities
• Quality-control systems
• Testing capabilities
• Technical personnel
• Samples can also be taken during the assessment if needed.

Step 5: Sample Testing & Report Evaluation

Where applicable, the samples are examined in a laboratory that is recognised by BIS in accordance with the appropriate Indian Standard, and the test results are assessed as part of the certification process.

Step 6: Closure of Non-Conformities

The manufacturer has to take corrective action if any non-conformities are found during the inspection or testing.

This may involve:

• Correcting manufacturing or quality issues
• Submitting additional documents
• Addressing testing deficiencies
• Providing evidence of corrective action

Step 7: Payment of Licence & Marking Fees

When the requirements necessary for certification have been fulfilled, the manufacturer pays the licence and marking fees specified in the certification scheme, if any are applicable.

Step 8: Grant of BIS Licence

When the necessary documentation, inspection, testing, and payment procedures have been carried out, BIS will issue the licence. The manufacturer can then apply the ISI Mark to the certified medical equipment in accordance with BIS requirements.

BIS ISI Certification Cost for Medical Equipment

The cost of BIS Certification for Medical Equipment depends on several factors, including:

The real costs involved in government action, carrying out tests in the laboratory, marking, and providing consultancy may differ according to the product and the relevant BIS requirements. Manufacturers must therefore get a cost evaluation which is specific to their product before beginning the application.

BIS ISI Certification for Medical Equipment Timeline & Validity

The BIS ISI Certification process for medical equipment usually takes about 30 to 40 working days in simple cases, while those requiring extra testing, inspection, technical evaluation, or corrective actions will take longer.

In some instances involving certain products or those which require extra assessment, the timeline can be considerably extended.

The validity of a BIS licence is determined by the relevant certification scheme and the licence conditions. Manufacturers should review the particular terms of their licence and carry out the renewal requirements within the specified time frame in order to ensure continuous compliance and the legal use of the ISI Mark.

Common Challenges Manufacturers Face for Medical Equipment

Getting BIS Certification for medical equipment can be difficult if manufacturers fail to take the product-specific requirements into account.

Common challenges include:

• Selecting the wrong Indian Standard
• Confusing BIS certification with CDSCO licensing
• Incomplete technical documentation
• Insufficient factory testing facilities
• Missing calibration records
• Inadequate quality-control procedures
• Non-conforming samples
• Delayed responses to BIS queries
• Lack of factory readiness during inspection
• Incorrect product scope or variants
• For foreign manufacturers, incorrect or incomplete AIR documentation

BIS also points out for applicants from abroad that delays may take place due to incomplete applications, delayed replies, arrangements for inspections, and other pending matters.

How UMSPCS Can Help Manufacturers to Get BIS ISI Certification for Medical Equipment

At UMSPCS, with 6+ years of experience, we give manufacturers a method of achieving regulatory compliance that is focused on documentation and is specific to their products.

UMSPCS assists manufacturers in dealing with certification by adopting a systematic and product-specific strategy, drawing on the compliance experience of its staff and their knowledge of more than 600 product compliance requirements across a number of industries.

Our assistance for BIS Certification for Medical Equipment can include:

• Identifying the applicable Indian Standard
• Assessing BIS applicability and certification route
• Reviewing product specifications
• Preparing and checking technical documents
• Evaluating factory readiness
• Coordinating testing requirements
• Supporting BIS application filing
• Assisting with BIS queries
• Supporting factory inspection preparation
• Guiding foreign manufacturers on AIR-related requirements
• Supporting post-licence compliance

Conclusion

BIS Certification for Medical equipment manufacturers in India should not be regarded as a universal approval; the right course of action is to first identify the product in question, determine the relevant Indian Standard, check the compulsory certification requirements, and also take into account other regulatory requirements such as those set by CDSCO.

If you are an Indian manufacturer who wishes to obtain BIS ISI Certification for Indian Manufacturers or if you are a company based overseas looking into getting BIS Certification for Foreign Manufacturers, adequate preparation can make the certification process more organized and foreseeable.

We can provide help with the assessment specific to products, with regard to documentation, coordinating testing, offering support for the BIS application, and dealing with the compliance requirements from the beginning through to the end.

Planning to launch medical equipment in India? 

Contact UMSPCS now to check your BIS certification requirements before you start the application.

Read more also: How CDSCO Certification Protects General Hospital Revenue

FAQs

1. Is it necessary for all medical equipment in India to have BIS Certification?

BIS certification is only obligatory in relation to products which are the subject of an applicable compulsory certification requirement, QCO, or other government directive.

2. What constitutes BIS Certification for medical equipment?

This is certification of a BIS product showing that it conforms to the applicable Indian Standard for medical equipment that is covered by the relevant certification framework.

3. Is it possible for foreign manufacturers to apply for BIS certification?

Foreign manufacturers who are eligible may apply via the Foreign Manufacturers Certification Scheme (FMCS) and have to satisfy its requirements, including that of an AIR nomination.

4. Is approval from the CDSCO equivalent to BIS ISI certification?

The regulation of medical devices is the responsibility of the CDSCO, whereas BIS certification ensures conformity with the applicable Indian Standards within the relevant BIS scheme.

5. What medical equipment needs to have BIS certification?

The requirements vary according to the product and the relevant notification. The Bureau of Indian Standards includes among its medical equipment certification programme products such as certain clinical thermometers and diagnostic medical X-ray equipment.

6. What would occur if the product fails the BIS tests?

Before certification can take place, the manufacturer might have to determine the cause of the non-conformity, implement corrective action, and comply with the relevant BIS requirements.