What Documents Are Required for MD-14 and MD-15? The MD-14 and MD-15 documents required for a CDSCO medical device import license generally include the Form MD-14 application, Power of Attorney, authorized agent’s license or registration, Free Sale Certificate/Marketing Authorization, quality-management documentation, Plant Master File (PMF), Device Master File (DMF), labels [...]
Introduction An MD-14 and MD-15 registration consultant prepares and files Form MD-14, the application submitted by an Indian authorized agent to CDSCO for importing a medical device, and manages the application until CDSCO grants Form MD-15, the medical device import license. The consultant can assist with preparing the Device Master [...]
Does Attar Require CDSCO Registration? In most cases, yes. Attar meets the legal definition of a cosmetic when it is intended to be applied to the body for fragrance. If you import attar, you need a CDSCO Import Registration Certificate in Form COS-2. If you make attar for sale in [...]
Introduction NPPA medical device pricing rules in India work across several requirements. Scheduled devices, such as certain coronary stents, must not be sold above the ceiling price notified by NPPA, along with applicable GST. Non-scheduled devices are generally subject to the 10% MRP-increase limit within the applicable 12-month period under [...]
Introduction NPPA IPDMS 2.0 registration for medical device companies is the online process of creating a company account on nppaipdms.gov.in, selecting “Medical Device” as the product type, and then adding your plants and device models so you can submit the pricing forms and information required by NPPA under the DPCO. [...]
What Is NPPA Registration for Medical Devices? NPPA registration for medical devices generally refers to registering the relevant company and medical-device pricing information on IPDMS 2.0, the Integrated Pharmaceutical Database Management System operated by the National Pharmaceutical Pricing Authority (NPPA). NPPA uses IPDMS 2.0 to collect and manage pricing information [...]
It depends on how the essential oil is used and marketed. Essential oils intended for application to the body or hair can fall under the cosmetics framework, while other uses may be regulated differently. Where the product is a cosmetic, imports require CDSCO registration and domestic manufacturing requires the applicable [...]
Introduction Non-hydroalcoholic perfume registration in India depends on where the product is made. Imported alcohol-free perfume, attar or perfume oil needs an Import Registration Certificate (Form COS-2) from CDSCO, applied for in Form COS-1 through SUGAM. Perfume made in India needs a manufacturing license (Form COS-8) or loan license (Form [...]
Introduction Hydroalcoholic perfume CDSCO registration means obtaining an Import Registration Certificate (Form COS-2) from the Central Licensing Authority before importing ethanol-based perfumes for sale in India. The importer, authorized agent, or manufacturer submits Form COS-1 through the SUGAM portal, along with documents such as an authenticated manufacturer authorization, Free Sale [...]
Hydroalcoholic vs non-hydroalcoholic perfumes can fall under cosmetic regulation, and imported cosmetics must be registered with CDSCO through Form COS-1 to obtain Form COS-2, subject to the applicable classification and requirements. Do Hydroalcoholic and Non-Hydroalcoholic Perfumes Need Different CDSCO Registration? Both fall within the cosmetics import-registration framework, and imported cosmetics [...]
