Posted by It is essential for medical businesses in India to comply with international standards. The Bureau of Indian Standards (BIS) is an esteemed certification that ensures the quality and safety of medical devices. It is especially crucial to adhere to it because of the increase in age-related, chronic and lifestyle diseases in India. BIS certification for medical devices in India ensures that patients and healthcare staff receive high-quality, reliable devices that improve treatment outcomes.
Let’s explore more about this important safety and quality standard for Medical devices in India.
What Is the Bureau of Indian Standards?
The Bureau of Indian Standards (BIS) is the promotes and governs the country’s standards of products. The BIS has Head Quarter in New Delhi and multiple branches and laboratories in India. These labs conduct testing of the samples of the products during the preliminary and surveillance stages. The BIS certification for products is mandatory in India and encouraged by the government to protect public health, provide quality assurance, and encourage public confidence.
What Is BIS Certification for Medical Devices in India?
India has reframed its framework governing quality assurance processes for medical devices in India. BIS certification for medical devices ensures proper and effective regulation of medical devices that are manufactured domestically or imported.
BIS has set the standards for various medical devices and equipment used in different medical disciplines. Some of these include Cardiology, Genecology, Orthopedics, Neurology, Radiology, Anesthesia, ENT, Ophthalmology, Dentistry and General Hospital Equipment’s among others. Besides, it also regulates other aspects of healthcare, such as hospital planning, the biocompatibility of medical devices, health informatics, medical nanotechnology, and more.
According to Rule 7 of Medical Device Rules 2017, medical devices belonging to classes A, B, C, and D are required to comply with BIS standards. However, if there are no standards laid down by BIS for a specific device, that device should comply with the International Organization for Standardization (ISO) or the International Electro Technical Commission (IEC), or by any other Pharmacopoeial standards. But if there are no standards laid by the body, the device should comply with those of the validated manufacturer.
Benefits of BIS Certificate For Medical Devices
There are several benefits of BIS registration. They are as follows:
1. Regulatory Compliance: It ensures compliance with Indian standards and legal requirements laid out by the Ministry of Health and Family Welfare and CDSCO.
2. Market Access: It opens up access to government tenders and hospitals that require certified products.
3. Enhanced Product Credibility: The BIS mark acts as a symbol of quality, safety, and reliability. It boosts consumer and healthcare provider confidence in the product.
4. Competitive Advantage: Enhances brand reputation and supports marketing claims about product quality.
5. Supports Imports and Exports: Indian BIS certification can help with smooth customs clearance for importers and can act as a quality credential in other emerging markets.
Who Is Eligible for BIS Certification for Medical Devices?
To be eligible for a BIS certificate for a medical device, the following requirements should be met.
- You must be a manufacturer, importer, or authorized representative of an importer or manufacturer.
- You must possess the required documents, such as the following:
- A copy of the test results of the medical device from a BIS-authorized lab.
- A copy of the workflow of the manufacturing operational procedure.
- A list of the equipment employed for testing
- The registration address and registration certificate of your manufacturing facility.
- Trademark registration
- Utility bills
- ID proofs authorized by the government.
- Details about the testing facilities and indicators of quality control
Summing Up
BIS certification is an indicator of the medical device’s quality, reliability, and safety. With the rise in the number of people suffering from various diseases, BIS certification ensures that the device for the treatment gives the best possible results. It also establishes the company’s reputation.
Frequently Asked Questions (FAQ’s)
1. Is BIS applicable to medical devices?
Yes, BIS is applicable for medical devices. The certification ensures that products comply with Indian standards, and are safe for the intended consumer.
2. Is BIS certification mandatory?
BIS certification is mandatory for specific products in India. It is needed to obtain clearances from government agencies. A BIS certification also allows businesses to access the Indian market and broaden their customer base.
