Medical Device Regulations In India You Should Know

Companies launching medical devices in India often count on the established consultancy platforms for adequate support while entering the market. It is necessary to comply with the guidelines while seeking Medical equipment registration. The authorities modify the rules and come up with new regulations from time to time. Last year, new regulations were introduced in the industry. It is necessary to seek professional support from the consultants, as the business firms are often unaware of the existing rules. You would like to stay away from legal hassles, when you launch your medical devices.

Prior to the formulation of these regulations, only fourteen medical devices had to be registered. This list has been modified and you need to stay abreast with the latest regulations in the industry. Medical firms willing to enter the market in India require an import license. At present, the medical device industry in India is valued at $5.5 billion. The industry has been growing at a 17% annual rate since 2017. As the industry soars to greater heights, new regulations have come into play. If you are willing to penetrate deep into the market in India, you need to seek the expert assistance from the consultants. It is important to adhere to the guidelines established by the Medical Device Regulation India. Have a look at the key areas of the new regulations in the medical device industry.

  • The new medical devices rules, formulated in 2017, had been scheduled to be implemented from 2018. The list of fourteen devices has been removed and now, the medical devices have been divided into four categories. All the medical devices have been placed in a respective class, depending on the use. The risk associated with their use has also been considered in the process. The classifications are:
  1. Class A, involving low risk
  2. Class B, involving low moderate risk
  3. Class C, involving moderate high risk
  4. Class C, involving high risk

The regulatory process for each of these classes is different. The approval process gets more complicated, with the increment in the risk level of these devices.

  • One can complete the application process online, for licenses to sell and distribute the products.


  • The local manufacturing sites will be audited by notified bodies, in order to ensure that the products fulfil the standards. These are nationally-accredited third-party bodies, that have the licenses of the government to audit the medical devices. They ensure that the products are of standard quality to prevent the entry of substandard grades of products in the market.


  • India’s Central Licensing Authority may inspect the foreign manufacturing sites. Sites that are located outside India may be inspected and they will have to pay $6,000 as an inspection fee in the process.


  • The approved medical devices, in 2022, must have unique identifiers. The medical devices approved for import, distribution and sale in India should have two types of unique identifiers. One is the device identifier, and the other is production identifier.

While entering the market, you need to stick to the guidelines. You may be looking forward to obtain the Medical Device license, if you are planning to launch a medical device. The process is complicated, and evidently, you need to seek the assistance from the consultants.

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