MD-42 Wholesale Registration: Who Needs It and How to Get It
A manufacturing or import licence does not let you sell onward. MD-42 wholesale registration does. Who needs it, what the application requires, and where it goes wrong.
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BIS Certification or CDSCO Licence: Which Does Your Medical Device Need?
BIS and CDSCO are not alternatives. Two authorities, two separate questions, and a product can need one, both or neither. How to work out which applies to yours.
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Indian Authorised Agent for Medical Devices: CDSCO Guide
What an Indian Authorised Agent does under the Medical Devices Rules 2017, the MD-14 to MD-15 pathway, agent liability, and why appointing your distributor as agent can cost you the Indian market.
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BIS Certification for Medical Devices in India – Complete Guide
Introduction India’s medical device industry is rapidly evolving, with increasing regulatory focus on quality, safety, and standardization. One of the key regulatory frameworks ensuring product quality is the BIS (Bureau of Indian Standards) certification, commonly known as the ISI Mark. If you are a manufacturer, importer, or distributor of medical devices, understanding BIS requirements is…
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Unveiling CDSCO Insights: Top 10 FAQs from My Professional Journey
Q: What are the current audit timelines for medical device regulation, and how have they changed recently? A: The audit timelines have become more stringent due to increased regulatory oversight. Recent changes include shorter notification periods and more comprehensive audit scopes. Manufacturers need to be audit-ready at all times, emphasizing continuous compliance. Q: What major…
