The Drugs and Cosmetics Act, 1940; and Rules, 1945 defines the requirement for import, manufacture, sale and distribution of Medical devices in India. Currently the below 13 notified Medical Devices are regulated under this Act.
| S. No. | Name of Device |
| 1. | Disposable Hypodermic Syringes |
| 2. | Disposable Hypodermic Needles |
| 3. | Disposable Perfusion Sets |
| 4. | Cardiac Stents |
| 5. | Drug Eluting Stents |
| 6. | Catheters |
| 7. | Intra Ocular Lenses |
| 8. | I.V. Cannulae |
| 9. | Bone Cements |
| 10. | Heart Valves |
| 11. | Scalp Vein Set |
| 12. | Orthopedic Implants |
| 13. | Internal Prosthetic Replacements |
Further the below 8 products are classified as “Drugs” in comparison to them being regulated as ‘Medical Devices’ in the International markets.
- Blood Grouping Sera
- Ligatures, Sutures, Staples
- Intra Uterine Devices (Cu-T)
- Condoms
- Tubal Rings
- Surgical Dressing
- Umbilical Tapes
- Blood / Blood Component Bags
Although the above list might act as a good guideline for products requiring registrations in India, the list is not limited to this. To see a more comprehensive list (but not limited to) please visit our blog Notified Medical Devices in India
It is often recommended to get a No Objection Certificate (NOC) from the CDSCO for the cases where the manufacturer is unclear about the regulatory status of their product in India. The CDSCO will review the product information and other related documents. Upon assessment they will issue a written statement on the regulatory status of your products. It takes anywhere between 4 to 12 weeks for the CDSCO to process the application and issue the No Objection certificate.
Morulaa can assist in this process. Please contact our team to learn how.
