Service overview
Medical devices are subject to DRAP classification, establishment and product registration requirements.
Sector permissions are generally activity-, product-, facility- or location-specific. Some applications require technical studies, inspections, environmental clearance or preliminary consent from other bodies.
Who can register a medical device with DRAP?
Determine device class, importer/manufacturer status and risk-specific registration requirements.
Medical device manufacture/import establishment licensing and product classification must be satisfied separately. Class A enlistment requirements differ from B, C or D registration.
Documents and information for Medical Device Registration Applications
Prepare the following information for medical device registration applications. The relevant regulator may require further forms or certified evidence, depending on the applicant and chosen procedure.
- Device specifications and risk classification
- Manufacturer authorisations
- Quality certification
- Technical file
- Labels and local representative.
How do I register a medical device with DRAP?
- 01Classify device class and local/import status
DRAP uses class A enlistment and class B/C/D registration, with separate manufacture/import establishment licences.
- 02Obtain device establishment licence first
Use DRAP Form 1 for manufacturing establishment or Form 2 for importing medical devices where applicable.
- 03File correct product form and technical dossier
Use Form 6/6-A for Class A or Form 7/7-A for Class B, C and D, with risk, quality and manufacturer documents.
- 04Address DRAP technical assessment
Respond to Medical Device Board/registration screening and maintain post-market vigilance and renewals.
Regulator resource: DRAP device form 1, 2, 6 and 7 classifications
After registration or approval
Maintain vigilance, labelling, device traceability and renewal/variation requirements.
Governing law & official references
Drug Regulatory Authority of Pakistan Act, 2012 and the product, establishment and medical-device rules applicable to the activity.
The links below lead to government or official regulatory sources relevant to this service. Use the currently consolidated Act, regulations, statutory checklist and official portal when making an application.
How Chambers can assist
Chambers can review the legal route, identify regulatory constraints, prepare or review the supporting corporate and legal documents, manage the prescribed submission and correspond with the competent authority where instructed. The scope of the engagement will be determined by the applicant’s particular circumstances.
For an initial enquiry, identify the proposed activity, applicant entity and current stage, and provide the available documents indicated above. Please avoid sending confidential or identity-sensitive records through an unencrypted first contact.
Common questions about Medical Device Registration Applications
Who is eligible for Medical Device Registration Applications in Pakistan?
Determine device class, importer/manufacturer status and risk-specific registration requirements.
What documents are needed for Medical Device Registration Applications?
Device specifications and risk classification; Manufacturer authorisations; Quality certification; Technical file. Additional requirements can apply to the actual business or regulator.
How do I register a medical device with DRAP?
Classify device class and local/import status: DRAP uses class A enlistment and class B/C/D registration, with separate manufacture/import establishment licences. Obtain device establishment licence first: Use DRAP Form 1 for manufacturing establishment or Form 2 for importing medical devices where applicable. File correct product form and technical dossier: Use Form 6/6-A for Class A or Form 7/7-A for Class B, C and D, with risk, quality and manufacturer documents. Address DRAP technical assessment: Respond to Medical Device Board/registration screening and maintain post-market vigilance and renewals.
This guide is general information, not advice on your facts. Check the applicable law, notifications, updated regulator checklists and jurisdiction before acting. The authority alone determines eligibility, acceptance and approval; no outcome or processing period is guaranteed.