Medical Device Manufacturers Likely To Get More Time To Secure Licences

The government might allow companies that make medical devices like ventilators, nebulisers, and x-ray machines, which are considered high-risk, to keep making these devices for a short time, as reported by the Economic Times. This is because there has been a delay in giving them new licenses that they need to continue their production, it added.

The Central Drugs Standard Organisation (CDSCO) was supposed to give out these licenses by October 1st, but they couldn't do it on time. So, it's likely that the companies that have already asked for licenses might get more time to keep making these devices, but only for a limited period. However, those companies that haven't even applied for a license won't get any extra time.

The reason for all this is that starting from October 1st, the government wants to make it a rule that all medical devices with 'moderate' and 'high' risks (called 'class C' and 'class D') should be regulated by CDSCO. This rule is to ensure that all medical devices, whether made locally or imported, meet certain quality standards before they can be sold in the country.

Previously, some manufacturers conveyed in the media that they applied for a license back in July, but they are still waiting for audits to be done before they can get their licenses.

So, in summary, the government is allowing some companies to keep making high-risk medical devices for a little longer because they haven't been able to issue the required licenses on time. But this extension is only for those companies that applied for licenses before, not for those who didn't apply at all. The government is doing this to make sure that all medical devices sold in the country are of good quality and safe for people to use.