BIS Certification for Medical Devices - Process & Documents

Introduction

Medical devices directly impact patient safety, diagnosis, treatment, as well as healthcare outcomes, making product quality and regulatory compliance especially important for businesses dealing with the same. As India’s healthcare and medical device industry continues to expand, manufacturers and importers need to understand the certification requirements that are applicable to their products before selling or importing them in the Indian market.

Where a medical device is covered under a mandatory BIS requirement, manufacturers must demonstrate absolute conformance with the applicable Indian Standard and obtain the required BIS certification for medical devices before manufacturing, importing, or selling the product in India.

This guide explains BIS certification for medical devices, including its benefits, applicable requirements, certification process, documentation, role of a BIS consultant, and key compliance considerations for manufacturers as well as importers who are entering the Indian market.

What is the Meaning of BIS Certification?

BIS certification is a mandatory certification required for all products that have been notified by the BIS to meet the prescribed standards and benchmarks of quality in order to be eligible for smooth trade in the economy. The Bureau of Indian Standards is a national organization that regulates the performance standards of products being sold in the Indian market. According to their regulations, the products are required to go through proper testing and verification by the BIS authorities before they can be distributed in the market. 

There are some products, including medical devices such as medical-purpose food, solid stem-type thermometers, X-ray equipment, sanitary napkins, baby diapers, dental bibs, etc., that are mandated under BIS to obtain the ISI mark certification. These products must undergo rigorous testing at a lab that has been recognized by BIS and verification before being sold or imported into the Indian market. BIS-certified medical devices are trusted by consumers and provide easy market access to businesses concerning the same.

Therefore, manufacturers as well as importers must carefully understand the ISI mark regulations and know the meaning of BIS certification before entering into market opportunities.

What is the Importance of BIS Certification for Medical Devices?

• Compliance with Legal Regulations
  If you’re a manufacturer, obtaining BIS certification for medical devices is a mandatory and legal requirement. Non-compliance with the regulatory standards may cause legal penalties, fines, as well as discontinuation of the products in the Indian market.
• Quality Assurance
  The BIS certificate for medical equipment ensures a common standard for manufacturing. The testing of these products is done according to the quality and safety standards as given in the regulations of BIS. Adhering to these standards allows manufacturers to produce, sell, as well as import products that align with high-performance standards.
• Customer’s Confidence
  The availability of high-quality medical devices instills confidence in consumers and maintains the sales of these products. Products that have been manufactured according to the BIS regulations ensure the safety, quality, as well as long-term reliability of the notified products, rendering them safe to be used at a large scale.
• Market entrance and acceptance
  Manufacturers who are dealing in the production, sale, and import of medical devices are mandated by the BIS to abide by regulations. Doing so makes it easy for them to gain market entrance and enhances the reputation of their brand. This also gives them a competitive edge in the market and opens new opportunities nationally as well as internationally.
• Cost Efficiency
  The ISI mark certification for medical devices enables manufacturers to sell and import them legally in India. Therefore, there is no requirement for any other certification, which saves money as well as time for the manufacturers. 

How to Obtain BIS Certification for Medical Devices?

Let us understand the complete process to get BIS Certification for medical devices:

Step 1: Identify the relevant Indian Standard for your medical device and prepare the in-house testing facilities to meet those standards. If you do not know which IS applies to your product, check your eligibility for a BIS certification today. 

Step 2: Get the product sample tested in a BIS-recognized laboratory.

Step 3: Register on the official Manakonline portal of BIS and fill out the application form. Prepare all the necessary documents and submit them along with the BIS certification fee.

Step 4: Prepare for the BIS factory inspection by coordinating travel and accommodation. The inspection will be done by visiting the factory and checking the quality, production process, and testing capabilities.

Step 5: Submit the inspection and audit fees.

Step 6: Prepare a sample product for testing in the allocated lab by BIS. 

Step 7: In case of non-conformity, check and correct the issues and submit the proof of it.

Step 8: On completion of the testing and verification by BIS, the authorities will issue the BIS-ISI certificate for the medical device.

Note: The BIS certification process varies for foreign and domestic manufacturers. It is therefore important to understand the BIS ISI certification in detail and prevent last-minute errors in the application.

Documents Required for BIS Certification for Medical Devices

The necessary documents required for a BIS ISI Certification generally include the following:

• Legal address proofs of the factories
• Product specification
• Details of raw material, machinery, and testing equipments
• Details of QC Staff and other basic details of the factory
• Lab test reports of the product
• Main Application Form V
• ISI Application Fee
• Appointment of AIR (Authorized Indian Representative) in case you are a foreign manufacturer

Note: You can appoint Brand Liaison, the top BIS ISI certification consultant, as your AIR. 

What is the BIS Fee for Medical Device Businesses?

The BIS fee varies depending on several factors such as product type, lab testing charges, AIR requirements, additional compliance considerations, etc. However, here is a simplified breakdown of the general estimate of the BIS certification cost:

You can contact Brand Liaison India and know the exact pricing for a BIS ISI Mark certification.

Why Do Businesses Need a BIS Consultant for Medical Devices?

BIS certification for medical devices can involve various technical standards, product testing, manufacturing controls, documentation as well as continuous interaction with BIS. Identifying the correct standard and certification path (for domestic and foreign businesses) at the beginning is particularly important because the requirements can vary according to the product.

• A BIS consultant can comprehensively help businesses to carefully understand the applicable requirements, review technical as well as application documents, coordinate testing, prepare the manufacturer for inspection and assist in resolving non-conformities or errors if there are any.
• This can help reduce avoidable documentation errors, testing delays as well as compliance gaps during the certification process.
• BIS itself requires manufacturers to demonstrate appropriate manufacturing infrastructure, process controls, quality-control and testing capabilities.
• Moreover, expert guidance and assistance can also streamline as well as fast-track BIS applications for businesses. 

Thus, coordinating with the best BIS ISI mark consultants in India, can surely help businesses in preventing unavoidable delays and hassles.

How Brand Liaison Helps with BIS Certification for Medical Devices?

Brand Liaison, the best BIS ISI certification consultant in Delhi, provides end-to-end assistance for businesses who are seeking BIS certification for medical devices. Our team helps identify the applicable Indian Standard and certification requirements before moving ahead with testing as well as license application.

Our support majorly includes documentation review, testing coordination, BIS application assistance, factory inspection preparation, technical compliance support as well as end-to-end assistance with resolving queries or non-conformities. For eligible foreign manufacturers, we can also assist with the applicable Indian representative and FMCS-related requirements.

Here is how businesses benefit from partnering with Brand Liaison:

1. Cost-effective compliance management solutions
2. Tailored certification support
3. Dedicated guidebooks for product approvals
4. Product eligibility checking assistance
5. Expert consultancy
6. AIR support for foreign manufacturers

With more than a decade of experience in product certification, Brand Liaison helps manufacturers navigate the certification process in a structured manner while keeping the focus on regulatory accuracy, timelines as well as efficiently meeting the market-entry requirements.

Conclusion

Medical devices are essential in providing better diagnosis, screening, as well as the treatment of patients. The BIS standards make sure that these products are of high quality to safely understand and treat the patients. If a medical device is in non-compliance with the BIS standards, it can pose a threat to the health of the patients and invite legal repercussions. In order to avoid such issues and create reliability towards your medical equipment, you can approach an ISI mark consultant in India such as Brand Liaison to help you get through the certification process with minimum effort.

With our help, the process of certification can be done without missing the necessary details and with utmost accuracy. You can contact us today to initiate your journey towards BIS certification today.