The transition of Class A and Class B medical device makers to the licensing regime by October 1 seems to be an uphill task with several small and medium manufacturers saying they are still awaiting the audit from the government authorities. If the licenses don’t come through, either due to lack of audits or MSME units not clearing the audits, then a few thousand small-scale medical device units will face the issue of business continuity in three weeks. Class A medical devices are those with low to moderate risk to the patient or user (surgical dressings for example), while Class B medical devices refer to devices with moderate risks that require special controls (catheters for example).
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