Stepwise procedure (Manually Submitted & Un Attended) Medical Devices Cases
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Stepwise procedure for submission of documents for Class A, B, C & D Medical Devices (Manually Submitted, Un-Attended Cases) as per requirement of Drug Regulatory Authority of Pakistan
Stepwise procedure (Manually Submitted & Un Attended) Medical Devices Cases
- 1. Stepwise procedure for submission of documents for Class A, B, C & D Documents (Manually Submitted, Un-Attended Cases) Step 1: Go to https://www.dra.gov.pk/ Step 2: Navigate to E-Services. Step 3: Click on E-Services and navigate to Case Management and click on Access Service. 3-A: 3-B: Note: To avoid Step 1,2 & 3 directly login at https://eapp.dra.gov.pk/login.php
- 2. Step 4: Enter your login details and press the Login button. After Login following screen will be shown.
- 3. Step 5: Go to Case Management (CMS). Step 6: Under Select Division heading from dropdown select Medical Devices Division. 6-A:
- 4. 6-B: Step 7: Under Select Query Type heading from dropdown select respective Class i.e. Class A Documents (Manually Submitted, Un-Attended Cases) or Class B & C Documents (Manually Submitted, Un-Attended Cases) or Class D Documents (Manually Submitted, Un-Attended Cases). Step 8: Important Instructions must be read before submitting your application.
- 5. Step 9: Attach necessary documents. 1. R&I Receiving, Fee Slip and Signed Form-7A 2. Letter of Authorization 3. Tabulated Data as per Annex-II of DRAP Letter 4. ISO 13485 certificate Valid CE Certificate Stability study (Combined All) 5. Free Sale Certificate & Declaration of Conformity Step 10: Submit application and make sure disclaimer is checked before submission and cover note is added.