{"id":51956,"date":"2023-01-25T12:31:35","date_gmt":"2023-01-25T07:01:35","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=51956"},"modified":"2025-01-20T18:23:48","modified_gmt":"2025-01-20T12:53:48","slug":"bis-certification-for-medical-devices-isi-and-fmcs","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/bis-certification-for-medical-devices-isi-and-fmcs\/","title":{"rendered":"BIS Certification for Medical Devices"},"content":{"rendered":"\n

The Indian economy is the world’s fastest-growing, with characteristics that allow it to compete with the world’s largest multinational economies. Due to globalisation, more trade is now possible in sectors such as manufacturing, services, international sales of goods, and import-export. In this blog, we will discuss BIS for Medical Devices registration<\/a><\/strong> in India.<\/p>\n\n\n\n

The Indian healthcare sector has grown to become\none of the largest in terms of revenue and employment. The healthcare sector\nincludes hospitals, medical devices, clinical trials, outsourcing,\ntelemedicine, medical tourism, health insurance, etc. <\/p>\n\n\n\n

In India, the healthcare delivery system is divided\ninto two key components: public and private. The first is the public healthcare\nsystem, which concentrates on offering primary healthcare centres (PHCs) in\nrural areas while including limited secondary and tertiary care facilities in\nmajor cities. The second is that the private sector supplies the bulk of\nsecondary, tertiary, and quaternary care facilities, with a concentration in\nmetros, tier-I and tier-II cities.<\/p>\n\n\n\n

India manufactures a wide range of medical devices, from consumables to implantable medical devices. The majority of medical devices produced in India are implantable items like cardiac stents, drug-eluting stents, intraocular lenses, and orthopaedic implants as well as disposable items like catheters, perfusion sets, extension lines, cannulas, feeding tubes, needles, and syringes. The medical device industry demands significant investment in cash as well as ongoing training for healthcare professionals to keep up with emerging innovations. According to the Economic Survey of 2022, India’s public healthcare spending in 2021-22 was 2.1% of GDP, up from 1.8% in 2020-21 and 1.3% in 2019-20.<\/p>\n\n\n\n

The status of a medical device was enlarged beyond the 23 previously notified medical devices on April 1, 2020, requiring that all medical devices be registered under The Drugs and Cosmetics Act of 1940<\/strong>[1]<\/strong><\/a><\/sup>. Beginning October 1, 2022, all Class A and B medical devices must be imported with an Import License. All remaining Class C and D devices that have yet to be notified will require Medical Device Import Licenses<\/a><\/strong> by October 1, 2023.<\/p>\n\n\n\n

Let’s take a closer look at the parameters in order\nto comprehend all of these processes.<\/p>\n\n\n\n

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