LICENSING AND ENLISTMENT/ REGISTRATION OF MEDICAL DEVICES

LICENSING AND ENLISTMENT/REGISTRATION OF IMPORTED MEDICAL DEVICES FORM-4 & FORM-8A

Only holder of Establishment License as Importer of Medical Devices (Form-4) can apply for Enlistment/Registration of Imported Medical Devices. Enlistment/Registration process of imported medical devices is completed in below mentioned two steps.

STEP 1 ESTABLISHMENT LICENSE AS IMPORTER OF MEDICAL DEVICES FORM-4

PMD provides comprehensive consultancy services to guide you through each step from correct selection of premises to installations, documentation and training of staff for successful inspection and licensing.

Company Registration

Company Registration as sole proprietor or partnership firm or Pvt Ltd.

Services Offered

NTN Registration
Sole Proprietor Company Registration
Partnership Firm Registration
Pvt Ltd Company Registration
Sales Tax Registration

Premises & Personnel

Premises with covered area suitable for storage and distribution of medical devices intended to be imported.

Storage facility containing

Air conditioner
Refrigeration facility for controlled temperature devices only
Environment Monitoring Devices
Racking facility for storage of drug products
Fire and safety devices

Hiring of Qualified Person with any of following degrees

Pharm-D
Biomedical Engineering
DVM
MSC Microbiology
BS Biotechnology
BS Medical Laboratory Technology

Application

Service Offered

Preparation and submission of licensing application (Form-2) in Drug Regulatory Authority of Pakistan

Inspection and Licensing

After successful scrutiny of application federal drug inspectors conduct inspection of premises and system in place for safe distribution of Medical Devices. Establishment License as Importer of Medical Devices (Form-4) is granted after successful inspection.

Services Offered

Development and implementation of GDPMD procedures
Training of staff on SOPs and record keeping for successful inspection

PMD Consultancy provides technical support to answer queries by Drug Regulatory Authority of Pakistan until issuance of Establishment License as Importer of Medical Devices (Form-4).

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STEP 2 ENLISTMENT/REGISTRATION OF IMPORTED MEDICAL DEVICES (FORM-8A)

PMD Consultancy services provides complete solution for Enlistment/Registration of imported medical devices.

Our services include:

Communication of exact documentation requirements to foreign manufacturer
Review of soft copies of documents before asking foreign manufacturers to go ahead with attestation/legalizations
Compilation of Enlistment/Registration Applications followed by submission in DRAP Islamabad.

PMD Consultancy provides complete support to answer queries by competent Drug Regulatory Authority of Pakistan until issuance of Form-8A.

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LICENSING AND ENLISTMENT/ REGISTRATIONS OF LOCALLY MANUFACTURED MEDICAL DEVICES

Only holder of valid Medical Devices Manufacturing License (Form-3) can apply for enlistment/registration of locally manufactured medical device.

Below are steps for licensing and registration of locally manufactured medical device.

STEP 1 MEDICAL DEVICES MANUFACTURING LICENSE (FORM-3)

Company Registration

Services Offered

NTN Registration
Sole Proprietor Company Registration
Partnership Firm Registration
Pvt Ltd Company Registration
Sales Tax Registration

Site Approval

Not all sites are suited/approved by DRAP to establish a medical devices manufacturing unit. Seeking PMD expert advise will help you save money and precious time.

Service Offered

Site survey and expert advise on suitability to setup pharmaceutical unit
DRAP Site Approval Application process

Layouts Approval

Services Offered

Layouts Development
DRAP Regulatory Submission and approvals

Civil Work as per approved layouts

PMD provides complete solution through its sister concern Megacon

Megacon offers below mentioned services

Working Plans Development
Structural Drawings
Civil Work Execution
Electric Load Calculation

CQV Services

Services Offered

PMD Consultancy Services provides complete technical support so that you get full value of your investments when it comes to procurements of Plant Machinery and Quality Control Test Instruments.
Our subject matter experts compare and validate contractors offers, job execution and documentation against quality standards to pass GMP and DRAP inspection requirements.

Medical Devices Manufacturing License Application Process

Services Offered

Regulatory Submissions and follow up
Technical support related to Inspection and Licensing

PMD Consultancy provides complete support to answer queries by competent Drug Regulatory Authority of Pakistan until issuance of Medical Devices Manufacturing License (Form-3)

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STEP 2 MEDICAL DEVICES ENLISTMENT/REGISTRATION (FORM-8)

Services Offered

Compilation of Medical Devices Enlistment/Registration Application and subsequent submissions in Drug Regulatory Authority of Pakistan (DRAP)
PMD Consultancy provides complete support to answer queries by Drug Regulatory Authority of Pakistan until issuance of Medical Devices Enlistment/Registration Certificate (Form-8)

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