| Regulatory Authority | Department of Pharmacy, Drugs and Laboratories (DPML) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I (except reagents) ,II,III and condoms |
| Medical Device Regulations | Procedures For The Approval Of Medical Devices | Click Here |
| Registration Timeline | 3 months |
| Technical Documentation Format |
Refer Section B and C | Click Here |
| Requirement of Authorized Representative | YES |
| Adverse Event Reporting Form | Download |
| Additional Information | Guide for medical device is currently being developed |