The Indian government has revised the Medical Devices Rules to simplify business. There is an enormous medical device industry worth $15 billion in India, and the new rules will help to streamline the process.
The first major change is about sterilisation, which is the process of making medical tools completely clean and safe. Many medical companies do not clean their products themselves. Instead, they send them to outside facilities. Before this change, companies had to get a special “loan licence” to do this, even if the cleaning facility was already approved and licensed by the Central Drugs Standard Control Organisation (CDSCO).
Now, the government has removed this rule. If the outside facility already has a valid licence, the manufacturing company does not need a separate one. They can print the cleaning facility’s licence number on the product package. Companies have been given six months to update their labels.
The second big change helps advanced medical tools enter India much faster. The government has added the European Union (EU) to its list of trusted international bodies. The list currently comprises the US, the UK, Australia, Canada and Japan. Hence, in case a technologically advanced medical device has been certified for use in Europe, it will not have to undergo any local trials before being marketed in India.
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Industry experts, including leaders from the Association of Indian Medical Device Industry (AiMeD), have welcomed this move. They believe it balances patient safety with business growth. Overall, these reforms keep medical products safe while helping the Indian medical industry grow faster.
