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Pakistan Medical Device Registration

Pakistan Medical Device Regulation

Updated on 01/04/24

Regulatory Authority: Medical Devices and Medicated Cosmetics Division, Drug Regulatory Authority of Pakistan

Drug Regulatory Authority of Pakistan (DRAP) is responsible for providing effective coordination and enforcement of The Drugs Act, 1976 (XXXI of 1976) and to bring harmony in inter-provincial trade and commerce of therapeutic goods.

Therapeutic goods regulated by the DRAP include:

  • Pharmaceutical and biological drugs for human or veterinary use,
  • Medical Devices and Medical Cosmetics
  • Health & OTC (non-drugs) also known as alternative medicines such as:
    • Ayurvedic
    • Chinese
    • Unani
    • Homeopathy
    • Nutritional products
    • Food supplements for human beings, animals

DRAP ensures that therapeutic goods, approved and available in market, meet prescribed standards of quality, safety and efficacy. The regulatory functions performed by DRAP include registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight, pharmacovigilance, and lot release of biologicals etc.

Link for Regulatory Authority: https://www.dra.gov.pk/

Local Regulation: https://www.dra.gov.pk/about-us/legislation/acts/

What is a Medical Device?

Medical devices include any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings or animals for one or more of the specific medical purposes of—

  • diagnosis, prevention, monitoring, treatment or alleviation of disease;
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
  • investigation, replacement, modification or support of the anatomy or of a physiological process;
  • supporting or sustaining life;
  • control of conception;
  • disinfection of medical devices; or
  • providing information by means of in-vitro examination of specimens derived from the human body,

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means.

Classification:

Class

Risk-Level

Example

Class A

Low

Tongue depressors/ disposable masks

Class B

Low-Moderate

Hypodermic Needles / suction equipment

Class C

Moderate-High

Lung ventilator / bone fixation plate

Class D

High

Heart valves / implantable defibrillator

Listing or Registration Requirements:

  • Importers must first obtain an Establishment License to import medical devices from DRAP.
  • The applicant must submit online application
  • Submission of online application is followed by the submission of the hardcopy of the application to Medical Devices Division, DRAP on Form-2.
  • Once the complete application is received in DRAP, the storage premises may be visited by the panel constituted by DRAP.
  • The Competent Authority to grant License is Medical Device Board (MDB)

Documents Required:

  • Complete description of the medical device with intended use;
  • Explanation of novel features, if any;
  • Indications that the device will diagnose, treat, prevent, cure or mitigate, Contraindications, Warnings to inform on specific risk or hazard that a user needs to know before using the medical device
  • Sample of labels on the medical device and its packaging
  • Instructions for installation and maintenance, if applicable
  • Any information and instructions given to the patient, including instructions for any procedure the patient is expected to perform, if applicable.
  • Promotional material and product brochures.
  • Sample of labels on the medical device and its packaging
  • Information on validation for medical devices with sterile or with measuring function, where applicable
  • Provide complete documentation related to the manufacturing and quality control processes. 

Registration Fee:  https://www.dra.gov.pk/?s=Fees&submit=Search

License Validity: 5 Years

Special Labelling Requirements: All applications and supporting documents shall be in English

Who should make this communication:

  • Manufacturer
  • Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

  • Act as your Authorized representative

Why Choose Us

  • Working towards client satisfaction
  • Cost effective solutions
  • Project completion before deadline
  • Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]

 

 

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