How to Manufacture Class A & B Medical Devices in India: State FDA License Guide
A quick guide on the Class A & B Medical Device manufacturing license — covering State FDA rules, Form MD-3/MD-5, fees, and timelines for manufacturers. Every manufacturer entering India’s device market must secure a Class A & B Medical Device manufacturing license before commercial production begins. This applies specifically to […]
Read MoreCan You Change Your Authorized Agent in India?
A quick guide on Change Authorized Agent India requirements, the role of a CDSCO Authorized Agent, and how foreign manufacturers manage this transition. Yes, a foreign manufacturer can absolutely change its Authorized Agent India appointment whenever business needs, performance concerns, or compliance requirements make a switch necessary. The process is […]
Read MoreAI/ML-Based Medical Devices — Emerging Regulatory Questions
Traditional Medical Device regulation assumes a fixed product: what’s approved is what ships, indefinitely, until a formal change is filed and reviewed. Adaptive AI and machine learning algorithms break that assumption by design — a model that continues learning after deployment is, in a meaningful sense, a different product than […]
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The Cosmeceuticals Grey Zone: When a Cosmetic Claim Risks Becoming a Drug Claim
“Cosmeceutical” is a popular marketing word. It suggests something more powerful than an ordinary Cosmetic — a product that treats skin condition, not just improves appearance. The problem is that Indian law does not recognize “Cosmeceutical” as a regulatory category at all. A product is either a Cosmetic or a […]
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Post-Market Surveillance for Cosmetics in India: What CDSCO Expects After Launch
Getting a Cosmetic product registered and onto shelves in India is only half the job. Once a product is in the market, the Cosmetics Rules, 2020 place ongoing duties on manufacturers and Importers to keep watching it. This is called post-market surveillance, and it is becoming one of the areas […]
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Software as a Medical Device (SaMD) – India’s Regulatory Stance
Although software intended for Medical purposes has been regulated in India since the implementation of MDR, 2017 Rules. CDSCO’s Guidance Document on Medical Device Software (Doc No. CDSCO/MD/GD/MDSW/01/2026), issued on 21 July 2026, represents the first comprehensive regulatory guidance dedicated specifically to software-based medical technologies. Through Circular F. No. MED-16028/2/2025-office, […]
Read MoreRegulation/Guidelines
Ingredient Safety Dossiers: Building a Defensible Package for Novel Actives
Companies developing Cosmetics with new or unusual active ingredients face a higher regulatory bar in India than those using well-established formulations. Understanding what “new” means under the Cosmetics Rules, 2020, and what needs to go into a safety dossier, can save months of delay at the approval stage. Step One: Find Out If Your Ingredient Is Actually […]
Regulation/Guidelines
Post-Market Surveillance and Pharmacovigilance Compliance Under India’s PvPI Framework
A practical guide to post-market surveillance obligations, adverse event reporting timelines, PSUR filings, and CDSCO enforcement trends under India’s PvPI framework. Getting a Drug approved in India is only half the journey. Post-market surveillance and Pharmacovigilance compliance under India’s PvPI framework continue for the entire lifecycle of the product, not […]
Regulation/Guidelines
Cosmetic Claims Substantiation: What Counts as Evidence Under Indian Rules
Walk down any Cosmetics aisle and you will see claims like “clinically proven,” “dermatologist tested,” or “reduces fine lines in two weeks.” These claims sell products — but under the Cosmetics Rules, 2020, they also come with legal responsibility. Under Rule 36 of the Cosmetics Rules, 2020, a Cosmetic must […]