BIS ISI & Foreign Manufacturer Certifications

BIS ISI & Foreign Manufacturer Certifications

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.

Bureau Of Indian Standards For Medical Device

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:

IS 3055 (Part 1): Clinical thermometers :Part1 Solid stem type
IS 3055 (Part 2) Clinical thermometers :Part 2 Enclosed scale type
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.

Foreign Manufacturers Certification Scheme(FMCS): 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:

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.
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.
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

Frequently Asked Questions

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

Application fee (Non Refundable) ₹1000/-
Annual License fee ₹1000/-
Renewal application fee (Non-refundable) ₹1000/-
Marking fee As applicable
Special Visit Charges ₹ 7000/- per man-day
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.

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.

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.