2018 has been a very eventful year for Regulatory in India. The Indian FDA Central Drugs Standard Control Organisation (CDSCO) has formally recognized medical devices as a separate division from Drugs with the Landmark Medical Device Rules, 2018.
Medical Device Rules 2018:
The following are some of the key features of new Medical Device rules which impact your business in India are:
- There is no distinction between Indian Agent and Importer: This means that, the local Indian company who holds the license, can only import the Medical products into India.
- Medical Devices are Classified as Class A – Class D: This means that, the time to obtain approval may be impacted by which class your medical product is.
- Fees is now US $3000 per manufacturing site and US $1500 per device family. License is valid for perpetuity: This means that, the fees have about doubled. However, where the full application needed to be made every 3 years, now the retainer fee has to be paid every 5 years, provided no changes in the device
The most important impact this will have on doing business is who you select to serve as your Indian Agent. As now, the relationship would be deeper – a firm which will hold your license to doing business in India and also serve as the official importer into the Country. At the same time, you would need to engage with a company which has experience in handling both regulatory and Importation/ legal requirements for selling medical devices in India.
How Morulaa Can Assist?
- Morulaa can serve as your Regulatory Holder and Importation Partner to allow you complete control on supplying your Medical devices across India.
- Management from Morulaa’s team including our support staff, usage of Importer office premises, usage of Importer facilities for warehouse and storage, customs clearance and importation
Morulaa is already offering Medical Device importation support to several manufacturers globally .
Please contact your Morulaa Representative to Learn more about how we can assist in ensuring smooth business in the Indian subcontinent for Medical Device registration and Importation