DRAP · South & Southeast Asia

Pakistan medical device regulatory resources

Every Pakistan dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

6,673 registration records10 free resources23/25 requirements covered8 regulations trackedAug 2026 fees reviewed

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Medical device registration database

Search official DRAP device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official DRAP regulations and guidance documents.

Government registration fees

Review current DRAP application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely DRAP pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent DRAP policy, guidance, and compliance updates.

AI medical device classifier

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Pakistan requirements.

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Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Structured regulatory requirements

Explore all 41 source-linked facts →

23 of 25 research dimensions currently covered · 7 official sources · latest verification 2026-08-29

Market entry

D01

Authority & regime

Verified

DRAP regulates medical devices through the Medical Device Board (MDB): The Drug Regulatory Authority of Pakistan (DRAP) administers medical device regulation through its Medical Devices and Medicated Cosmetics (MDMC) Division; the Medical Device Board (MDB) is…

1 source-linked fact

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Medical Devices Rules 2017 made as S.R.O. 32(I)/2018 under section 23 of the DRAP Act 2012: The Medical Devices Rules, 2017 were made by DRAP as S.R.O. 32(I)/2018 dated Islamabad, 16 January 2018, in exercise of powers conferred by section 23 of the Drug Regulatory Authority of Pa…
Medical Devices Rules 2017 repeal the Medical Devices Rules 2015: Rule 74 repeals the Medical Devices Rules, 2015 and all other rules, notifications, orders and instruments made under the DRUGS Act or the DRAP Act in so far as they regulate medical device…

2 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Medical device definition covers instruments, software, IVD reagents and materials for humans or animals: Rule 12(1) directs the MDB to enlist and register medical devices defined as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material…

1 source-linked fact

Checked 2026-08-25

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D04

Classification rules

Verified

Risk classes A through D.: Class A, Class B, Class C, Class D

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Class A devices are enlisted; Class B, C and D devices are registered: Pakistan operates a two track market authorisation system under rule 13: Class A medical devices obtain enlistment, while Class B, C and D medical devices require registration.
Applications may only be made by a licensed manufacturer or by an importer acting as authorized representative: Under rule 14(1) an application for enlistment or registration of a medical device may be made only by (a) an establishment holding a valid licence to manufacture medical devices, or (b) an…

2 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

Rule 67 lists reliance reference countries plus WHO prequalification and CE marking: Rule 67 names the reference countries and schemes whose market authorisations DRAP relies on: USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Neth…
Devices from reference authorities, WHO-prequalified or CE-marked devices are exempt from foreign manufacturing-site inspection: Under rules 15(2) and 15(3), devices registered by the authorities of the rule 67 countries are exempt from inspection of manufacturing units abroad irrespective of where the manufacturing…

3 source-linked facts

Checked 2026-08-25

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D07

Economic-operator roles

Verified

Foreign manufacturers enter through an importer acting as authorized representative holding an establishment licence: The local economic operator role for foreign devices is the importer acting as authorized representative in Pakistan who must hold a valid establishment licence; this party submits the enli…
Changes to enlistment or registration particulars require prior MDB approval: Under rule 17(1) the enlistment or registration certificate holder must apply to the MDB for prior approval of any change to the particulars provided for the enlistment or registration, or…

2 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Establishment licences are granted on Form-1/2 applications with premises inspection, issued on Form-3 or Form-4: Under rule 5, an application for an establishment licence is made on Form 1 (manufacture) or Form 2 (import); the MDB may inspect the premises, constituting a panel of experts which may inc…
No medical device may clear customs without a DRAP clearance certificate: Under rule 26(1), no medical device or component or raw material for manufacturing medical devices shall be released from customs unless a clearance certificate has been obtained by the imp…

3 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Transitional customs release required notarized ISO 13485, manufacturer authorization and a free-sale, conformity or CE certificate: Under the second proviso to rule 52(1), during the transitional exemption window (expiring 31 December 2022 per the exemption table), imported consignments of licensed importers and manufac…

1 source-linked fact

Checked 2026-08-25

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D10

Official forms & portals

Verified

MDMC licensing and registration applications are filed through the DRAP e-portal: Medical device licensing and registration applications in Pakistan are filed through DRAP's online MDMC portal at e.dra.gov.pk ('New MDMC Licensing and Registration'), which coexists with a…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Labelling must be in English; Urdu required for home-use devices: Under rule 41, the language used for labelling of medical devices shall be English; however, the use of Urdu language shall be required for home used medical devices.
Labels must carry identification details, registration number, MRP, manufacturer and importer or authorized representative details: Under rule 42, the label of a medical device must contain (a) details enabling identification — name, model if any, lot or batch or serial number, enlistment or registration number, date of…

3 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

MDB inspects establishment premises through a panel of experts including inspectors or auditors: Under rule 5(1), in processing an establishment licence application the MDB may inspect the premises of the establishment as it considers proper and necessary to verify information, particu…

1 source-linked fact

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

PNRA licence to operate a radiation facility or activity: Radiation
PNRA No Objection Certificate for import, issued only to licensees: Radiation
No PNRA control over non-ionizing equipment: Laser / UV / ultrasound

5 maintained overlays · 1 related fact

Checked 2026-08-29

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D14

Fees

Verified

Class A enlistment - local manufacture or import: PKR 6,300
Enlistment or registration - accessory or component, local manufacture: PKR 6,300

16 maintained fee lines · 2 related facts

Checked 2026-08-25

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D15

Review clocks

Unresolved

No authority-side decision deadline identified in the April 2022 consolidated Rules: No deadline for the Medical Devices Board or DRAP to decide an enlistment or registration application was identified in the Medical Devices Rules, 2017 consolidated through April 2022. Rule…

1 source-linked fact

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Enlistment and registration certificates are valid for five years: Certificates of enlistment or registration are valid for five years from the date of issue unless earlier suspended or cancelled; the condition is printed on the Form 8 certificate format.
Late renewal allowed within one year with monthly additional fee; after one year the authorization ceases and a fresh application is required: Under rule 16(5), a renewal application made after expiry but within one year attracts an additional fee equal to the applicable renewal fee for each month; after one year the enlistment or…

3 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Changes to enlisted or registered devices are handled only as prior-approval variations: The only change outcome the Medical Devices Rules, 2017 provide is a prior approval variation: under rule 17 the certificate holder applies to the MDB for prior approval of any change in pa…
No change event triggers a new application; fresh-application language exists only for late-renewal lapse: The rules contain no provision routing any change event (particulars, safety/performance change, representative change) to a new enlistment or registration application. The only fresh appli…

3 source-linked facts

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

Practitioners must keep records of implanted devices including batch number: Under rule 56(1), a qualified practitioner who places an implanted medical device into a person's body must maintain records of the patient's name, address, phone and identity card number,…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Small-quantity import of devices for clinical investigation or evaluation uses Form-9 and a Form-10 permit: Under rule 22(1), an application for an import permit for a small quantity of medical devices, components or raw materials for the purpose of clinical investigation, examination, test or an…

1 source-linked fact

Checked 2026-08-25

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D20

Special access & derogation

Verified

Special access devices defined for emergency use or where conventional remedies failed or are unsuitable: Rule 2(lxvi) defines a 'special access medical device' as a medical device intended to be used by a qualified practitioner in an emergency or in a case where all conventional remedies have…
MDB may grant emergency use authorization in public health emergencies, disasters and pandemics: Rule 75 (added by S.R.O. 599(I)/2022 dated 27.04.2022) allows the MDB to grant emergency use authorization to medical devices in a public health emergency, national disaster, natural calami…

3 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Licensees must establish and maintain a post-marketing surveillance and vigilance system: Under rule 49(1), for post marketing surveillance and vigilance of marketed medical devices, a licensee must establish, maintain and implement an appropriate and effective post marketing su…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Batch failures, unexpected side effects and performance failures must be reported to MDB within fourteen days: Under rule 19(9)(b), for new medical devices the registration holder must supply the MDB, as soon as possible and in any event within fourteen days, with reports in duplicate of all records…
Foreign safety withdrawals, bans and adverse reactions must be reported to MDB within thirty days: Under rule 19(10), where a device is approved for free sale by a related company in USA, EU countries, Canada, Japan or Australia and is withdrawn, banned or restricted for safety reasons i…

2 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Export permit holders must withdraw non-conforming batches from export and recall issued units on MDB direction: Under rule 31(c) and (d), an export permit holder informed by the MDB that part of a batch or lot has been found by the Authority not to conform to required specifications must, on directio…

1 source-linked fact

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Device advertisements require approval, are valid two years, and may only promote the authorized purpose: Under rule 66(2), approval of a medical device advertisement is valid for two years; under rule 66(3), no person shall advertise a medical device for any purpose except that for which it ha…

1 source-linked fact

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Appeals against MDB decisions lie to the Appellate Board within sixty days: Under rule 60, an aggrieved person or party may prefer an appeal before the Appellate Board of the Authority against a decision of the MDB within sixty days. A fee for appeal is provided in…

1 source-linked fact

Checked 2026-08-25

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Government fees

Full fee schedule (16 lines) →

DRAP registration fees in PKR · reviewed 2026-08-25

Fee line	Amount	Provenance
Class A enlistment - local manufacture or import	PKR 6,300	Verified
Enlistment or registration - accessory or component, local manufacture	PKR 6,300	Verified
Class B registration - imported device, accessory, or component	PKR 32,400	Verified
Class B registration renewal - imported device	PKR 15,700	Verified