Updated on October 17, 2024 11:29:03 AM
Medical Devices include equipment that are required in the Health Sector Industry. The equipment can be as menial as a Band-aid and as crucial as a Pacemaker.Medical devices must adhere to the specifications set forth by BIS and established under Section 3 of the BIS Act of 1985.
Any standard for medical devices that is not covered under BIS ACT OF 1985 shall comply with ISO (International Standard Organization) standards. In case medical equipment standards are not specified in any rule it shall conform to validated manufacturer’s standards
Foreign manufacturers must have FMCS accreditation in order to trade medical devices into India. While Indian manufacturers are permitted to create and market medical products with the ISI Mark.
Few health-related items are traded under voluntary certification, although some essential medical equipment must be FMCS Certified in order to be sold.
Note: Any medical device standard that does not comply to BIS Standard shall comply with ISO(International Standard Organization) . If any standard does not comply to BIS or ISO Standards, they shall conform to the validated manufacturer’s standards”
BIS Medical Device Sample Certificate
Medical Devices are used for the respective Patients. Its objective is to provide aid to the public suffering from a certain illness.India is considered as one of the largest healthcare sectors .
Safety and Reliability is the foremost responsibility of the manufacturers. FMCS registrations ensure that all the equipment are in accordance with BIS Standards, thus securing public health.As mentioned earlier, there are several medical equipment that have voluntary certifications which poses a threat to a patient’s life . In this case , it is even more essential to obtain any of the eligible BIS Certification.
FMCS Registrations also allows manufacturers to expand their business. Such certifications work as a proof of quality assurance as well as risk-free , which leads to reliability and confidence of customers in the organization. Along with that , it helps the manufacturers to distinguish itself from the competition. Consequently, a positive reputation of the particular organization is built which results in the increase in sales.
FMCS is an acronym for Foreign Manufacturers Certification Scheme . It states that all Foreign or International Manufacturers must apply for BIS registration to import the medical equipment within the country.
FMCS Registration ensures that the manufacturers who deal with Pharmaceuticals , drugs , thermometers,pregnancy kits or any implantable device produce and import High Quality Products, which are highly reliable , efficient and Safe for the use of patients. FMCS registration is a testament for the customers to use the medical device , in other words it benefits manufacturers in gaining the confidence of customers to make use of medical devices.
ISI refers to the Indian Standard Institution .Medical Device Manufacturers can use ISI Mark if their products are conforming to BIS Standards i.e. the products consist of top quality , highly efficient, and take care of the well-being of humans and animals.
Manufacturers that are looking to produce and sell medical devices within India have to obtain an ISI Certificate. The ISI mark is a proof that makes the customers trust the manufacturer and utilize the medical device to resolve their medical issue.
The process of registration can be categorized into the following steps:
At Professional Utilities, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.
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Businesses that comply with the standards set by the Indian government and obtain BIS registration can enjoy several benefits. These advantages include an increase in credibility, customer trust. BIS registration ensures that businesses comply with safety and quality regulations, which can prevent legal and regulatory issues and maintain a good reputation in the market. It can provide businesses with a competitive advantage by demonstrating a commitment to quality and safety.
BIS registration stands for compulsory registration scheme. It was introduced by the ministry of electronic and information technology (Meity). Under registration it is now mandatory for all the manufacturers and importers of electronic products to obtain BIS certification to commence business in India.
The application fee for BIS registration is 1000 rs only, however processing fee is INR 25,000 Including one test report and annual registration fee is INR 2000 valid for upto 2 years.
You can get your BIS certificate in 3 simple steps with Professional Utilities.
As per the guidelines issued by ministry of electronic and information technology MeitY all the importers of Toys are required to obtain BIS registration for their Import business.
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