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  • BIS for Medical Device (ISI Mark)

Bureau of Indian Standards for Medical Device

Applicability of BIS on Medical Devices:

BIS is the National standard Body of India established under the BIS Act 1986 for the harmonious development of the activities of standardization , marking and quality certification of goods and for matters connected therewith or incidental.

Around 1500 BIS standards are available for the Surgical Instruments, Orthopaedic Instruments, Implants And Accessories, Obstetric And Gynaecological Instruments and Appliances, Ear, Nose And Throat Surgery Instruments, Ophthalmic Instruments and Appliances, Thoracic And Cardiovascular Surgery Instruments, Neurosurgery Instruments Implants And Accessories, Dentistry, Artificial Limbs, Rehabilitation Appliances and Equipment for the Disabled, Medical Laboratory Instruments, Anaesthetic, Resuscitation and Allied Equipment, Hospital Equipment and Surgical Disposal, Veterinary Hospital Planning and Surgical Instruments, Hospital Planning, Eletromedical Diagnostic Imaging and Radiotherapy equipment, Health Informatics, Biological Evaluation of invitro Diagnostic Medical Devices, Medical Biotechnology and Nanotechnology, Hospital Bio Medical Waste Management And Infection Control, Anatomy and Forensic Sciences Equipment.

Types of BIS Licenses on Medical Device:

CRS Scheme: Electronics and IT Goods under ‘Compulsory Registration Scheme’ for Self Declaration of conformity-Notified by Ministry of Electronics And Information Technology.

ISI Mark: Generally, this scheme of ISI Mark is applicable on Medical Devices, at present, very few medical equipment are notified for mandatory ISI requirement. The list of Medical Equipment which fall under mandatory ISI are listed below:

  1. IS 3055 (Part 1): Clinical thermometers :Part1 Solid stem type

  2. IS 3055 (Part 2) Clinical thermometers :Part 2 Enclosed scale type

  3. IS 7620 (Part 1) Diagnostic Medical X-Ray Equipment

The process of ISI mark does involve detailed steps, to start with the implementation of the notified Indian Standard on the product for which we have applied ISI Mark. The implementation of the standard is the most curtail aspect since, it involves the heavy amount of documentation and practical demonstration of the product as per the conformity standards listed for the product in subject. In the medical device industry, ELT Corporate is one of the finest BIS-ISI Consultant with the blended team of scientific and regulatory professionals, who helps you to obtain the necessary approvals.

As a part of the process, the manufacturer needs to mandatorily have in-house Quality Assurance Laboratory.

FMCS: Foreign Manufacturers Certification Scheme – Overseas applicants/foreign manufacturers are granted a license for the use of ISI mark under separately designed scheme within 6 months period.

Special Provisions of BIS Requirement under Medical Device Rules, 2017

As per the clause (7) of MDR 2017, there is a requirement of product standard for a medical device.—

  1. The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.

  2. Where no relevant Standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down by the International Organization for Standardization (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeia standards.

  3. In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the device shall conform to the validated manufacturer’s standards.

BIS approved Medical device, is easier to avail the medical device registration. As both BIS and MDR works on nearby similar principles. BIS ensures the standard of conformity and MDR ensures the Quality assurance.

Process of getting BIS done on your MD:

 

  1. MAKE THE STEPS IN ACCORDIAN

Step-1: Selecting Scheme for BIS Certification

BIS Certification is provided in India for products under different types of schemes as follows:

  1. Normal Procedure for Domestic Manufacturers – The applicant is required to submit the BIS Certification application with required documents and requisite fee. After submitting the application, a preliminary factory evaluation is carried out by a BIS officer. Then samples are tested in the factory and also drawn for independent testing. BIS certification is provided if the sample is acceptable. In this method, BIS Certification is expected to be granted within 4 months of submission of application.

  2. Simplified Procedure for Domestic Manufacturers – In the simplified procedure, the applicant submits a test report of the sample from a BIS approved lab along with application for BIS Certification. If the test report is satisfactory, then a verification of the factory premises is carried out by a BIS Officer. BIS Certification is granted if the verification of BIS Officer is satisfactory. Under this method, license is expected to be granted within 30 days of submission of BIS Certification application with the required documents and test report.

  3. Tatkal Scheme: Those manufacturers who need BIS standard mark mandatorily as per Government notification can obtain BIS license under the tatkal scheme. Under the tatkal scheme, the application is processed within strict timelines and the total time for processing is specified as 30 days. In addition, application received under the Tatkal Scheme will be processed on priority basis to adhere to the strict time norms.

  4. ECO Mark Scheme – BIS License for eco-friendly products are granted in a scheme separate from the normal BIS Certification process. Eco-friendly products should conform to additional requirements specified in the Indian Standards to qualify for the ECO mark. The procedure for grant of license is however similar to that of Domestic Manufacturers scheme.

  5. Foreign Manufacturers Certification Scheme – Overseas applicants/foreign manufacturers are granted license for the use of ISI mark under separately designed scheme within 6 months period.

Step-2: Application, Fees and Documentations

The prescribed application Form has to be filled out by the applicant and submitted along with the application fee to the branch office of the jurisdiction in which the manufacturing unit is located.

  • The additional documents that are required to be submitted with the application are:

  1. Document of Central/State Government (e.g. Registration Certificate, MOA etc) authenticating the address and purpose of the establishment of the manufacturing unit for which the application is made for grant of BIS license.

  2. In case the applicant applies as SSI unit, a copy of valid Registration Certificate from the Local / State authority or from a Chartered Accountant.

  3. Process Flow-chart covering all processes of manufacture (from raw material to finished product stage), including details of in-process controls at each stage, even for those stages which have been outsourced?

  4. A detailed list of manufacturing machinery, with the name of the machinery, the process for which it is used, capacity and quantity in the format provided in Annex A-1.

  5. In case some of the manufacturing processes are outsourced, provide details of such processes and the controls exercised by you before receipt of such material/components, etc. also, attach an authenticated copy of the agreement.

  6. A complete list of testing facilities, clearly indicating the name of the equipment, the test for which it is used (mention clause No. of the Indian Standard), range / least count / accuracy of the test equipment, calibration status and quantity as per format provided in  Annex A-2.

  7. Copies of calibration certificates of testing equipment valid for a minimum of 3 months from the recording of the application.

  8. Where applicable, ‘consent letter’ from BIS recognized laboratory (for requirements which have to be and/or are proposed to be got tested from outside lab for which the applicant does not have in-house test facilities).

  9. Plant Layout that mentions the location of manufacturing machinery, office, storage area, etc., available on the factory premises.

  10. Appointment letter of QC personnel indicating names, experience, qualifications, date of appointment and also attach a copy each of the qualification certificates.

  11. Copy each of the test reports/suppliers’ test certificates for each of the raw materials/components.

  12. Copy of in-house or independent test report (if available) for the product covering all requirements as per the relevant Indian Standard.

  13. In case the application is signed by the authorized signatory of the applicant, authorization letter from CEO in the name of the authorized signatory.

Step-3: Site Inspection

After the submission of application , BIS officer will go for preliminary Inspection, after the inspection , the samples will be tested ,after completing all the evaluation, the final result will be derived .

Step-4 Surveillance Process

After the Inspection Process, the next process is called the surveillance process in which the factory complete survey is conducted. The following are the steps taken for the surveillance process ;

  • The Inspecting authority will visit the factory and testify it.

  • After the testing, the samples were taken.

  • The samples will be sent to the Independent labs.

  • The test report will brief the complaint or give feedback on the investigation.

  • The performance review report will be ready.

Step-5: Granting of License

After the Inspection , once the report is reviewed license is granted .

Frequently asked questions:

What Cost is involved in BIS?

During a BIS certification, a multiple costs are involved at various steps as such:

  1. Application fee (Non Refundable) ₹1000/-

  2. Annual License fee ₹1000/- 

  3. Renewal application fee (Non-refundable) ₹1000/- 

  4. Marking fee As applicable 

  5. Special Visit Charges ₹ 7000/- per man-day

  6. Testing charges, where required As applicable

To get the exact costs for your product BIS certification, contact our team immediately, and get the complete cost breakup for your product and exact timelines.

How we can help you for BIS?

ELT Corporate and Medical Device BIS:

ELT Corporate is renowned for its services in all the fields of scientific licenses staring from Legal Metrology, BIS, Drugs and Cosmetics, Medical Devices, Food Safety, Environment safety to New Technology Patent. ELT Corporate has a team of Advocates, Engineers, M.Pharma, Chartered Accountants, Company Secretary. With such a unique combination of talent under a single roof, it has always been a hassle-free wonderful experience to the big corporates.

ELT Corporate is one of the best medical device consultant in India and always try to provide the best experience to the clients.

How we can help you with BIS for your Medical Device ?

  • We help our clients to develop all the documents.

  • We help our clients to maintain various records mandatory as per BIS regulatory.

  • We even provide expert services on developing the Quality Assurance labs and testing labs and inspections.

  • We help our clients to communicate with government portals and ministry for getting the license done.

  • In short, we assure our clients about any regulatory requirement for the Medical Device in India.

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