Medical Device Regulatory Requirements in Pakistan
| Regulatory Authority |
Drug Regulatory Authority |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
A,B,C,D |
| Medical Device Regulations |
Medical Devices Rules, 2017 (Same Regulations for IVD)
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
https://www.dra.gov.pk/wp-content/uploads/2022/10/Medical-Devices-Rules-2017-updated-upto-april-2022-2.pdf |
| Registration Process |
Medical Device Registration
| Click Here
|
| Registration Timeline |
7 to 9 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Urdu (domestic use products) and English Language |
| Adverse Event Reporting Form |
Download |
| Additional Information |
In order to register an imported medical device in the country, the importer must first obtain an Establishment License to import medical devices from Medical Devices Division of DRAP. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025