Practice Area

Medical Devices Registration, regulatory affairs & Compliance

Overview

DRAP rules, regulations. Custom clearance, approvals, GD's, import and export laws, regulatory affairs, vetting and drafting documents, License for Importers, Regulatory Due Diligence, Cross-Border Medical Device Advisory, Shipment clearance assistance

Medical Device Registration & Import Services in Pakistan

By Your Trusted Legal & Regulatory Advisors

Are you planning to import, distribute, or register medical devices in Pakistan?
Our law firm provides complete legal and regulatory assistance for DRAP compliance, medical device registration, import licensing, and regulatory approvals.

Our Legal Services for Medical Device Companies

We assist:

  • Foreign manufacturers
  • Local importers
  • Distributors
  • Hospitals
  • Diagnostic companies
  • Healthcare startups
  • Surgical equipment suppliers

Our Services Include:

  1. DRAP Medical Device Registration 

2.    Establishment License for Importers

3.    Product Enlistment & Registration

4.    Import License & NOC Assistance

5.    Legal Review of Technical Documents

6.    Distributor & Agency Agreements

7.    Customs & Regulatory Compliance

8.    Labeling & Packaging Compliance

9.    Regulatory Due Diligence

10. DRAP Hearing & Compliance Representation

11. Product Recall & Risk Management

12. Cross-Border Medical Device Advisory

13. FDA / CE / ISO Compliance Guidance

14. Post-Market Surveillance Compliance

15. Healthcare Regulatory Litigation Support

Medical Device Registration Process in Pakistan

Step 1 — Appointment of Local Authorized Representative

Foreign manufacturers must appoint a Pakistan-based authorized importer/distributor.

Required Documents:

  • Power of Attorney
  • Agency Agreement
  • Company incorporation documents
  • NTN & Sales Tax Registration

Estimated Timeline:

3–7 working days

Step 2 — Establishment License from DRAP

This is the mandatory first approval for importers/distributors.

Required Documents:

  • Company registration certificate
  • NTN
  • Sales tax certificate
  • Warehouse details
  • Qualified technical person documents
  • Lease agreement/ownership documents
  • SOPs & storage procedures

Estimated Timeline:

30–60 days

Step 3 — Classification of Medical Device

The product is classified under:

  • Class A
  • Class B
  • Class C
  • Class D

We help determine the correct classification to avoid regulatory delays.

Estimated Timeline:

3–10 working days

Step 4 — Product Registration / Enlistment

Required Documents:

Corporate Documents

  • Free Sale Certificate
  • Manufacturing License
  • ISO 13485 Certificate
  • Power of Attorney

Technical Documents

  • Device Master File
  • Product specifications
  • Intended use
  • Label artwork
  • Instructions for use
  • Clinical evidence
  • Risk analysis reports

Estimated Registration Timelines

Device Class

Estimated Timeline

Class A

1–3 months

Class B

4–6 months

Class C

6–9 months

Class D

8–12 months

Import Process for Medical Devices in Pakistan

We Assist Clients In:

Import Documentation

  • Import permits
  • DRAP approvals
  • Customs documentation
  • Product registration certificates

Customs Clearance Support

  • GD filing support
  • HS code guidance
  • Regulatory compliance review
  • Shipment clearance assistance

Labelling Compliance

We ensure labels comply with DRAP requirements including:

  • Product name
  • Manufacturer details
  • Batch/lot number
  • Expiry date
  • Storage instructions
  • Sterility information

Common Problems We Help Clients Avoid

  • Wrong device classification
  • Delayed DRAP approvals
  • Customs detention issues
  • Incomplete technical dossiers
  • Labeling non-compliance
  • Unauthorized distribution disputes
  • Expired registrations
  • Product recall risks

Why Clients Choose Our Law Firm

✔ Complete end-to-end legal support
✔ Fast-track regulatory coordination
✔ DRAP compliance guidance
✔ Cross-border import advisory
✔ Commercial & distribution agreement drafting
✔ Corporate + regulatory legal support under one roof
✔ Assistance for foreign manufacturers entering Pakistan market

Industries We Serve

  • Surgical devices
  • Diagnostic equipment
  • Dental devices
  • Laboratory equipment
  • Hospital technology
  • AI-based healthcare devices
  • Medical software & digital health solutions
  • Implantable devices
  • Pharmaceutical equipment

Need Assistance With Medical Device Registration in Pakistan?

Our legal and regulatory team assists clients from document preparation to DRAP approvals and import compliance.

Contact Us For:

  • Medical Device Registration
  • DRAP Licensing
  • Import Compliance
  • Distributor Agreements
  • Healthcare Regulatory Advisory
  • Customs & Regulatory Representation

 

Frequently Asked Questions

Drug registration in Pakistan is regulated by the Drug Regulatory Authority of Pakistan (DRAP). The process generally includes: *Appointment of local authorized agent/importer *Company enlistment and licensing *Submission of technical dossier *Product evaluation and laboratory testing *Pricing approval (where applicable) *Grant of registration certificate

Free Sale Certificate GMP Certificate Manufacturing License Certificate of Pharmaceutical Product (CPP) Stability studies CTD dossier Product specifications and labels Power of Attorney

The registration timeline depends on the nature of the pharmaceutical product and the completeness of documentation. Estimated Timelines: Registration Type Estimated Timeline Generic medicines 6–12 months Imported pharmaceuticals 8–14 months Biological products 12–24 months Medical devices 3–12 months Renewal applications 2–6 months Delays may occur due to: Deficiency letters from DRAP Incomplete dossiers Laboratory testing requirements Pricing approvals Inspection issues Early legal and regulatory review significantly reduces approval delays.

Companies involved in import or export of drugs must obtain several regulatory approvals before commercial operations. Common Required Licenses: Establishment License Drug Sale License Import License Product Registration Certificate Export NOC (where applicable) Controlled substance permissions (if applicable) Import Compliance Requirements: Customs clearance documentation Batch release certificates Temperature-controlled logistics compliance Labeling compliance under DRAP rules Pharmacovigilance obligations Exporters may also need: Country-specific regulatory approvals WHO-GMP compliance International product certifications Non-compliance during import/export may lead to detention of shipments or cancellation of licenses.

Pharmaceutical products must comply with DRAP labeling and packaging regulations before sale or import into Pakistan. Mandatory Label Information: Generic and brand name Active ingredients Manufacturing and expiry dates Batch/Lot number Storage instructions Manufacturer and importer details Registration number Dosage instructions Warning statements Products with misleading, false, or incomplete labeling may be: Seized by authorities Recalled from market Penalized under applicable drug laws Proper legal review of artwork and packaging helps avoid regulatory action.

Non-compliance with pharmaceutical regulations may result in severe civil, criminal, and administrative penalties. Common Violations: Importing unregistered drugs Selling counterfeit or adulterated medicines Operating without valid licenses Misbranding or false claims Failure to maintain quality standards Unauthorized distribution Possible Penalties: Heavy monetary fines Product seizure and destruction Suspension or cancellation of licenses Blacklisting by authorities Criminal prosecution Imprisonment in serious violations Product recalls and business closure Regulatory investigations may also expose companies to customs, tax, and consumer protection liabilities.

Legal and regulatory advisors assist pharmaceutical businesses in managing compliance obligations throughout the product lifecycle. Compliance Support Typically Includes: Drug registration assistance Import/export compliance advisory Review of technical dossiers GMP and pharmacovigilance compliance Drafting distributor and agency agreements Regulatory audit preparation Product recall management Representation before DRAP and regulatory authorities Cross-border pharmaceutical compliance Professional regulatory guidance helps companies minimize delays, avoid penalties, and maintain uninterrupted market access.
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