New Set Of Medical Device Regulations In India Business Firms Should Be Aware Of

The medical device industry in India is fast growing. Both international and domestic players have a good opportunity for business in the country. In case you are willing to launch a medical device business in India, it is recommended to reach out to the established consultants in the industry. The experts will provide you with the necessary support, when you start your business. At the outset, it is important to adhere to the norms established by Medical Device Regulation India. Failure to comply to the guidelines can land your business in legal hassles. Well, the rules are changing and the norms are being modified with time. For instance, in 2017, new rules were introduced in the industry. Often, companies are unaware of these new guidelines and land up in trouble. A dedicated support from the consultant can keep your business on the right track.

First of all, you need to get the medical devices registered. According to the earlier set of rules, only ten medical devices needed registration. In case you are a foreign business and want to enter the Indian market, it is necessary for you to obtain an import licence. Competition in the industry is soaring. Whether you need a professional assistance while dealing with Technical Dossier  or licensing, the experts will help you out.

Here are some of the new guidelines that you should know.

The medical devices are to be categorized into four groups, in place of the list of ten devices. Any business entering the market needs to place the product in the right category. This is decided according to the nature of use of these devices and the risk associated with the same. Each of these classes have got a different regulatory process. The process of getting an approval becomes more difficult, as the risk level in the devices increase.

The classifications include:

  • Low risk devices: Class A
  • Low moderate risk devices: Class B
  • Moderate high devices: Class C
  • High risk devices: Class D

Well, you can complete the application process online and obtain the licences to distribute these products for sale.

Notified bodies will audit the manufacturing sites, so that they can ensure that the medical devices fulfil the expected standards. Depending on the size and nature of your business, you need to obtain the Import/Manufacturing License. The consultants will help you out in dealing with these legal aspects. The auditing authorities are third-party bodies, having a national accreditation.

The manufacturing sites of foreign companies will be inspected by the Central Licensing Authority of India. The companies have to pay a charge for $6000 to get the sites outside India inspected.

In case you are trying to start a medical equipment business in India, it is wise to get a solid backing from the experts. They will help you to obtain the Import License, or the Manufacturing License, whichever is applicable in your case. The seamless assistance from the experts will keep you on the right track and prevent you from running into legal hassles. Get across to a reputed consultant, when you start your business.

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