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? — step-by-step guide
- 01Identify the appropriate application route and eligibility
First determine whether the proposed applicant and activity fall within this procedure. Determine device class, importer/manufacturer status and risk-specific registration requirements. Review the separate conditions and exclusions in the eligibility section before submitting any form or payment.
- 02Prepare the application documents and evidence
Start with the particulars listed for this service: Device specifications and risk classification; Manufacturer authorisations; Quality certification; Technical file; Labels and local representative.. Ensure the names, applicant identity and documents are consistent. The authority may require further supporting material under its current checklist.
- 03Check the current regulator instructions before filing
Refer to the regulator resource identified on this page (DRAP device form 1, 2, 6 and 7 classifications ↗). Reconfirm the currently prescribed forms, online or physical submission method, supporting evidence, fee and any current amendments. Do not assume that historic processing times or fees remain applicable.
- 04Classify device class and local/import status
DRAP uses class A enlistment and class B/C/D registration, with separate manufacture/import establishment licences.
- 05Obtain device establishment licence first
Use DRAP Form 1 for manufacturing establishment or Form 2 for importing medical devices where applicable.
- 06File 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.
- 07Address DRAP technical assessment
Respond to Medical Device Board/registration screening and maintain post-market vigilance and renewals.
- 08Keep the approval record and track ongoing obligations
After the authority has made its decision, retain the acknowledgement, correspondence, evidence of approval and any conditions attached to it. Maintain vigilance, labelling, device traceability and renewal/variation requirements. Check whether separate approvals, renewals or reporting duties apply to the actual business.
Use the current regulator checklist to confirm that every listed item is still required and that any activity-specific conditions have been met. The items below are drawn from the document requirements identified on this page, not a representation that the checklist is exhaustive.
- Device specifications and risk classification
- Manufacturer authorisations
- Quality certification
- Technical file
- Labels and local representative.
Before signing or paying, reconcile the particulars across Device specifications and risk classification and Manufacturer authorisations; check the applicant and business classification, identify the person authorised to submit, and retain a copy of the final application and official correspondence. Official instructions control if the portal or law has changed.
Regulator resource: DRAP device form 1, 2, 6 and 7 classifications
After registration or approval
Maintain vigilance, labelling, device traceability and renewal/variation requirements.
Medical devices: intended use, risk class, establishment and product authorisation
Primary-source research. The following procedural analysis is based on the identified government or regulator sources. Confirm enacted amendments, applicable forms, fees and filing requirements on the date of submission. A consultation draft is not operative law merely because it has been published. This note does not represent final legal-editor certification of the entire guide.
Decide whether the article is a medical device
DRAP's medical-device definition encompasses equipment, implants, in-vitro diagnostic reagents and certain software used for prescribed medical purposes, where the primary intended action is not pharmacological, immunological or metabolic. Device classification starts with manufacturer-stated intended use, medical claims, invasiveness, contact, duration and other risk characteristics. A product described commercially as wellness equipment may or may not fall within the defined medical-device perimeter.
Apply the appropriate risk route
The Medical Devices Rules, 2017 distinguish lower-risk Class A devices subject to enlistment and higher-risk Classes B, C and D requiring registration, as applicable to imported and locally manufactured devices. DRAP's Medical Devices Board administers establishment and product approvals and has updated rules, including an amendment to Rule 19 in June 2025. Confirm current exemptions or transitional notifications, not a generic assumption that all devices are registered under one form.
Prepare technical and applicant evidence
Compile licensed manufacturer/importer particulars, manufacturer authorisation where prescribed, device description and classification rationale, intended use, labelling, safety/performance and quality management evidence, relevant certificates, technical dossier and post-market systems. Device software may require a software-specific risk assessment. Check for foreign conformity certification, testing and reliance mechanisms where the actual rules permit them.
Obtain authorisation before placing products on the market
DRAP's online MDMC Licensing and Registration service supports product and establishment applications. Where imported, PSW can require separate import/release authorisations. Retain final enlistment or registration, device nomenclature, authorised manufacturer, importer and renewal conditions and vigilance procedures. Provisional status in a public spreadsheet is not a legally definitive approval record.
Official legal and regulatory sources
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.