BIS Certification for Mercurial Sphygmomanometers (IS 3390)

ISI Certification for Mercurial Sphygmomanometers certifies the device as per the Indian standard of accuracy, safety, construction and performance. This certification assures that the instrument is accurate in recording blood pressure and can be used by a professional medical person.

What is a BIS License for market approval?

The Bureau of Indian Standards (BIS) is the national body in India which is responsible for establishing quality, safety, and performance standards of products. The BIS license is issued to prove that a product meets the relevant Indian Standard and is safe to use.

In the case of mercurial sphygmomanometers, the licensing of IS 3390 is to guarantee that the instruments are produced out of approved materials and are designed in accordance with the standard requirements of the device. The ISI mark can be used by licensed manufacturers, which shows confidence and adherence in the Indian healthcare market. 

Why is ISI Mark Certification beneficial?

The most important reasons warranting the ISI mark certification of mercurial sphygmomanometers are:

1.  Ensures Accurate Blood Pressure Measurement : ISI-approved equipment offers accurate and reliable measurements, which are essential in the proper medical diagnosis..
2. Assures Product Quality and Safety : The certified sphygmomanometers are highly tested on the basis of mercury column accuracy, prevention of leakage and durability.
3. Compliance with IS 3390 Standards : The certification gives consistency in design, calibration, materials, and performance according to the Indian standards.
4. Acceptance in Medical Facilities : Because ISI-marked gadgets are guaranteed to be reliable and compliant with regulations, hospitals and medical facilities prefer them.
5. Legal and Regulatory Advantage: BIS certification assists manufacturers in fulfilling the required rules and playing in the governmental and institutional tender. 

What is IS 3390?

IS 3390 is an Indian Standard which outlines the requirements for a mercurial sphygmomanometer to be used in measuring blood pressure. This standard includes construction details, quality of materials, scale and accuracy, safety measures and workmanship.

It also defines testing methods to check accuracy of measurement, mercury column behaviour, airtightness and resistance to damage. Compliance with IS 3390 guarantees that the device is providing consistent results and is also safe when it is used regularly in medical usage.

Overall, IS 3390 assists in ensuring the uniformity, precision, and safety of blood pressure measuring tools used in the healthcare centres. 

Documents you must submit for BIS License?  

The following documents are necessary for Domestic Manufacturers:

1. List of raw material
2. Layout plan of the factory premises
3. List of testing equipment as per the Indian standard
4. Quality Control (QC) Personnel Details (Education degree and Aadhaar card)
5. GST
6. Authorized Person Aadhar & Pan Card
7. MSME
8. Electricity Bill
9. Email Address & Permanent Contact Number
10. Office Address
11. Factory Address
12. Copy of Partnership Deed / MOA (for Private Limited Co.)
13. Premises document / Rent Agreement
14. List of Manufacturing Machinery  

The following documents are necessary for Foreign Manufacturers:

1. Checklist for Application
2. Copy of Swift Remittance
3. Duly Filled Application Form
4. Copy of Business License
5. List of Machinery
6. List of Raw Material
7. Test certificate of Raw Material
8. List of Testing Equipment
9. Calibration certificate of Test Equipment
10. Process Flowchart
11. Layout Plan
12. Location Plan (Route Map)
13. Details of Technical Personnel
14. Qualification of QC
15. Copy of Certification of Product and/ System
16. Factory Test Report  
17. Agreement with AIR
18. Aadhar Card of AIR
19. AIR Nomination Form
20. Educational Degree of AIR
21. Undertakings
22. Scope of License

Process for ISI Certification?

There are two key procedures to get your BIS license: Simplified and Normal.

Simplified Procedure

The steps involved in the simplified procedure are:

1. Document Collection : All the necessary KYC and technical documents are collected in order to start the BIS application without problems.
2. BIS Portal Registration : The license application is processed by the manufacturer being registered on the official portal of BIS.
3. Pre-Testing of Samples : Before submission, product samples are tested in a BIS authorized laboratory.
4. In-House Lab Requirement : Depending on the product, an internal laboratory facility might be necessary according to the BIS requirements.
5. BIS Review & Clarifications : BIS analyzes the documents and test reports provided and can seek clarifications.
6. BIS Audit at Factory : Audit of the product samples carried out by the BIS inspectors is done at the factory. 
7. Timely Audit Completion : The audit, inspection and sample collection are conducted within 17 days of the application submission along with the EVTL India engineer.
8. EVTL India Engineer- Factory Inspection : The BIS auditor and an engineer at EVTL India undertake a proper inspection at the factory.
9. Independent Collection of Samples : The BIS auditor draws samples to be tested by the post-audit.
10. Sample Testing at BIS Lab : BIS sealed samples are sent to BIS laboratories, and the BIS department pays the price of testing.
11. Grant of BIS License : Upon satisfactory document inspection, testing and audit, ISI license is issued. 

Normal Procedure

The steps involved in the normal procedure are:

1. Submit Documents : Firstly, it is required to submit all the KYC and technical documentation to start the BIS application.
2.  Plan In-House Laboratory and Technical Proposal : Prepare an internal lab in case necessary and prepare all technical documentation.
3. Ready Factory Test Report (FTR) : Carry out in-house tests and document the FTR to demonstrate that the product is to the standards.
4. Submit Application & Fees : Includes your BIS application and the amount of fees necessary by the government.
5. BIS Audit : An audit of documents and processes at a BIS takes place within 3 weeks.
6. EVTL India Engineer Factory Inspection : BIS auditor inspects the factory with an EVTL India engineer to make sure that everything is in order. 
7. Sample Collection & Sealing : The BIS auditor picks samples randomly, puts them into a sealed sample and forward the sample to a BIS authorized lab to be tested.
8. License Approval : After the lab tests of the sample are passed-on, BIS issues the ISI license, and your product is certified and market-ready. 

Time duration to obtain BIS Mark  

According to IS 3390, the expected time duration for obtaining BIS Certification for sphygmomanometers (mercurial) is as follows:

• For Indian Manufacturers : 40-45 days
• For International Manufacturers : Approximately 180 days  

Why EVTL India is the best choice BIS Approval?

EVTL India is a reliable BIS consultant for sphygmomanometers (mercurial) and provides full end-to-end certification services. We are an experienced ISI consultant for sphygmomanometers (mercurial) and help manufacturers in documentation, coordination of laboratory tests, audits of factories and regulatory compliance.

EVTL India is also useful to foreign manufacturers with BIS Agent of Sphygmomanometers (Mercurial) and AIR-related formalities to assist connection with authorities of BIS. Through partnering with EVTL India, the foreign manufacturers can simplify the process of certification and enter into the Indian market with a lot of confidence, fulfilling all the BIS compliance requirements. 

Conclusion

Obtaining BIS Certification for Sphygmomanometers (Mercurial) under IS 3390 is necessary to guarantee medical accuracy and market acceptance. ISI Certification for Sphygmomanometers (Mercurial) will establish confidence within healthcare providers and institutions.

Using the services of EVTL India as your BIS consultant for sphygmomanometers (mercurial), you can easily get certified, gain credibility, and increase presence in the Indian medical device market.

Frequently Asked Questions (FAQs)

1. What is BIS registration for Sphygmomanometers (Mercurial)?

It certifies that the equipment is of the IS 3390 quality and safety standards.

2. Why is BIS Consultant significant?

A consultant assists in easy documentation, testing, audits and expedited approval

3. Who requires a BIS agent for sphygmomanometers (mercurial)?

Foreign manufacturers must appoint a BIS Agent (AIR) in India. 

4. What does the ISI mark tell us on sphygmomanometers?

It shows compliance to IS 3390 and BIS approval. 

5. What is the effect of BIS QCO on sphygmomanometer manufacturers (mercurial)?

It makes BIS certification compulsory in the manufacturing and sale of legal goods in India.