| 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 |
| Device Classification Guidelines | In Pakistan, medical devices are regulated by the Drug Regulatory Authority of Pakistan (DRAP) under the Medical Devices Rules, 2017 | Click Here |
| Registration Process | Medical Device Registration | Click Here |
| Registration Timeline | 7 to 9 months |
| Conformity Assessment Route |
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. | Click Here |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Urdu (domestic use products) and English Language |
| Labeling Requirements |
Refer to CHAPTER VI LABELLING OF MEDICAL DEVICES | Click Here |
| Fees for Submission |
Refer to Rule 63 | Click Here |
| Reportable Incidents |
ADVERSE EVENTS REPORTING GUIDELINES FOR PATIENTS, CARETAKERS AND CONSUMERS. | Click Here |
| Advertising and Promotions |
Regulation of Advertisement of Therapeutic Goods | Click Here |
| 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. |
| Contact Phone | 0800-03727 |
| Contact Email | addl-dir.md.mc@dra.gov.pk |
| Contact Address | Drug Regulatory Authority of Pakistan Prime Minister’s National Health Complex Park Road, Chak Shahzad, Islamabad |