Pure Global AI
DRAP · structured requirements

🇵🇰 Pakistan medical device regulatory data

Explore the medical device requirements currently available for Pakistan, organized by topic and linked to official sources.

43 facts24 dimensions3 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

Compare countries

Device advertisements require approval, are valid two years, and may only promote the authorized purpose

advertisement-approval-regime
Fact-level verified

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 has been enlisted or registered. Rule 64 prohibits advertising a medical device by any means except as provided under the rules, and Schedule C of the rules set a separate advertisement fee (PKR 20,000 as consolidated till April 2022).

Conditions
  • Advertisement approval needed; purpose of advertising confined to the enlisted or registered purpose

Effective from 2018-01-16

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

Compare countries

Enlistment and registration certificates are valid for five years

authorization.duration
Fact-level verified

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.

Conditions
  • Validity may end earlier on suspension or cancellation

Effective from 2018-01-16

Confirms baseline.

Late renewal allowed within one year with monthly additional fee; after one year the authorization ceases and a fresh application is required

authorization.lapse
Fact-level verified

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 registration ceases to exist and the application is treated as a fresh application for grant of enlistment or registration.

Conditions
  • Late window of one year after expiry; additional fee per month of delay; fresh application thereafter

Effective from 2018-01-16

Confirms baseline. A parallel late-renewal rule applies to establishment licences (rule 7).

Renewal applications are due sixty days before expiry

authorization.renewal
Fact-level verified

Under rule 16(1), an application for renewal of a device's enlistment or registration, for local manufacture or import, must be made sixty days before expiry on Form-6 or Form-6A, Form-7 or Form-7A, accompanied by the application fee specified in rule 63.

Conditions
  • Separate form sets for local manufacture (Forms 6/6A) and import (Forms 7/7A); Forms 6A/7A added by S.R.O. 430(I)/2022

Effective from 2018-01-16

Confirms baseline.

Authority & regime

Which authority and binding regime govern this product, task, and date?

Compare countries

DRAP regulates medical devices through the Medical Device Board (MDB)

authority-mandate
Fact-level verified

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 responsible for enlistment and registration of medical devices, licensing of establishments, and issuance of import and export permits for medical devices, their components and raw materials.

Conditions
  • Applies to all medical devices regulated under the Medical Devices Rules, 2017

Effective from 2018-01-16

Confirms baseline. The MDB is the decision-making body for device enlistment/registration and establishment licensing under the rules.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

Compare countries

Changes to enlisted or registered devices are handled only as prior-approval variations

change.available-outcomes
Fact-level verified

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 particulars or any change affecting safety or performance, on Form-6/6A or Form-7/7A with the rule 63 fee, and the device must not be manufactured or placed on the market with the change until MDB approval. There is no alternative outcome routing a change to a new enlistment or registration application.

Conditions
  • Applies to changes in particulars and to safety/performance-affecting changes alike

Effective from 2018-01-16

Corrects baseline: the rules do not contemplate a new-registration outcome for changes; variation with prior approval is the single route.

Changed devices may not be manufactured or marketed until MDB approves the variation

change-market-hold
Fact-level verified

Under rule 17(3), upon receiving a change application the MDB may inspect the establishment to verify particulars, and the enlistment or registration holder shall not manufacture the medical device with the proposed change nor place it on the market until the MDB has approved the change; contravention of rule 17(1) or (3) can lead to cancellation or suspension of the enlistment or registration after an opportunity of being heard (rule 17(4)).

Conditions
  • Market hold applies from proposal of the change until MDB approval; enforcement via cancellation or suspension after hearing

Effective from 2018-01-16

No change event triggers a new application; fresh-application language exists only for late-renewal lapse

change.new-application-triggers
Fact-level verified

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-application triggers are expiry-related: failure to renew within one year after expiry of a device enlistment/registration (rule 16(5)) or of an establishment licence (rule 7), where the authorization ceases and the application is treated as fresh.

Conditions
  • Fresh application follows only from lapse of validity, not from any change event

Effective from 2018-01-16

Corrects baseline.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

Compare countries

Small-quantity import of devices for clinical investigation or evaluation uses Form-9 and a Form-10 permit

clinical-import-permit
Fact-level verified

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 analysis, or a sample for evaluation, is made to the Director, Medical Devices and Medicated Cosmetics on Form-9 with the rule 63 fee; the permit is issued on Form-10 (rule 22(2)).

Conditions
  • Small quantities only; purposes limited to clinical investigation, examination, test, analysis or evaluation samples

Effective from 2018-01-16

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

Compare countries

Medical device definition covers instruments, software, IVD reagents and materials for humans or animals

definition-device-scope
Fact-level verified

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 or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings or animals for diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury; or investigation, replacement, modification or support of the anatomy or of a physiological process.

Conditions
  • Definition covers devices for both human beings and animals; includes in-vitro diagnostic reagents and standalone software

Effective from 2018-01-16

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

Compare countries

Transitional customs release required notarized ISO 13485, manufacturer authorization and a free-sale, conformity or CE certificate

import-clearance-documents
Fact-level verified

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 manufacturers could be released by Pakistan Customs on submission of notarized ISO 13485 and a notarized letter of authorization from the foreign manufacturer, plus one of: notarized free sale certificate from country of origin, notarized declaration of conformity from the foreign manufacturer, or notarized production or full quality assurance certificate (CE-marking certificate) from a conformity assessment body.

Conditions
  • Operated during the rule 52(1) transitional exemption period ending 31 December 2022 (Class A end date; Class D ended 31 March 2022, Class C 30 June 2022, Class B 30 September 2022); historical — preserved as superseded transitional mechanism

Effective from 2018-01-16 · Effective until 2022-12-31

The document set shows the conformity evidence DRAP accepts (ISO 13485, FSC, DoC, CE). The exemption table in rule 52(1) set the staggered 2022 end dates per class.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

Compare countries

Foreign manufacturers enter through an importer acting as authorized representative holding an establishment licence

market-entry.local-role
Fact-level verified

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 enlistment or registration application under rule 14(1)(b).

Conditions
  • Applies to imported devices; local manufacturers apply through their own licensed manufacturing establishment

Effective from 2018-01-16

Confirms baseline.

Changes to enlistment or registration particulars require prior MDB approval

market-entry.representative-change
Fact-level verified

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 any proposed change that may affect the safety or performance of the device; the change application is made on Form-6/6A or Form-7/7A with the rule 63 fee (rule 17(2)).

Conditions
  • Covers both administrative particulars changes and safety/performance-affecting changes

Effective from 2018-01-16

Confirms baseline for representative/particulars changes: the mechanism is a prior-approval variation, not a new registration.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

Compare countries

No medical device may clear customs without a DRAP clearance certificate

customs-clearance-certificate
Fact-level verified

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 importer from an officer authorized by DRAP.

Conditions
  • Applies at the customs port at the time of arrival of shipment

Effective from 2018-01-16

Donation imports permitted except Schedule D products and Class C and D devices

donation-import
Fact-level verified

Rule 24A (inserted by S.R.O. 559(I)/2022 dated 27.04.2022) permits import of medical devices for the purpose of donation, including devices otherwise prohibited from import without enlistment or registration, except products included in Schedule D and classes C and D, subject to the condition that the device shall not be sold or distributed in the market.

Conditions
  • Not applicable to Schedule D products or Class C and D devices; donated devices must not be sold or distributed in the market

Effective from 2022-04-27

Inserted vide S.R.O. 559(I)/2022 dated 27.04.2022 per the consolidating footnote.

Establishment licences are granted on Form-1/2 applications with premises inspection, issued on Form-3 or Form-4

establishment-licence-procedure
Fact-level verified

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 include inspectors or auditors, and if satisfied issues the licence on Form-3 (manufacture) or Form-4 (import).

Conditions
  • Separate licence formats for manufacturing establishments and import establishments

Effective from 2018-01-16

Fees

What regulator fee applies to this class, route, event, and date?

Compare countries

Fees are set by DRAP fee notifications under the Fee and Levy Rules 2022; current instrument is S.R.O. 1399(I)/2025

fee-instrument-succession
Fact-level verified

Schedule C of the Medical Devices Rules, 2017 originally set the fees and rule 63(2) lets the Authority amend Schedule C with Policy Board approval; fee-setting has since moved to notifications issued under section 20(1) of the DRAP Act 2012 read with rule 4(3) of the DRAP (Fee and Levy) Rules, 2022. The current instrument, S.R.O. 1399(I)/2025 (Islamabad, 1 August 2025), partially modifies S.R.O. 496(I)/2023 dated 17 April 2023 and supersedes S.R.O. 1324(I)/2024 dated 30 August 2024, with the approval of the Policy Board.

Conditions
  • Succession chain: rules Schedule C (as amended till April 2022) then S.R.O. 496(I)/2023, then S.R.O. 1324(I)/2024 (superseded), now S.R.O. 1399(I)/2025 effective 1 August 2025

Effective from 2025-08-01

Preserves the superseded instruments as part of the succession; the historical Schedule C amounts are recorded in the government-fees typed findings.

Regulatory fees are non-refundable

fee-non-refundable
Fact-level verified

Rule 69 (substituted by S.R.O. 559(I)/2022) makes any fee specified under rule 63 and deposited in respect of any activity non-refundable; S.R.O. 1399(I)/2025 restates this for all regulatory services.

Conditions
  • Applies to any fee deposited for any regulatory activity or service

Effective from 2022-04-27

S.R.O. 1399(I)/2025, closing paragraph: 'The fee deposited for any regulatory service shall in no case be refunded.'

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

Compare countries

Instructions for use must cover contraindications, warnings and precautions

ifu-content
Fact-level verified

Under rule 44, an instruction for use shall contain details on any contra-indications, warnings and precautions, including precautions on performance changes or malfunction, exposure to environmental conditions (magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature, humidity), and an indication where drugs or medicinal products are incorporated into the device as an integral part.

Effective from 2018-01-16

Labels must carry identification details, registration number, MRP, manufacturer and importer or authorized representative details

labelling-content
Fact-level verified

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 manufacturing, date of expiry and the maximum retail price (MRP) fixed by the manufacturer; and (b) the name and complete address of the manufacturer, his licence number, and for devices manufactured outside Pakistan also the name and complete address of the importer or authorized representative.

Conditions
  • Importer/authorized representative name and address required on label only for devices manufactured outside Pakistan

Effective from 2018-01-16

Labelling must be in English; Urdu required for home-use devices

labelling-language
Fact-level verified

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.

Conditions
  • Urdu additionally required only for home-used devices

Effective from 2018-01-16

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

Compare countries

Licensees must establish and maintain a post-marketing surveillance and vigilance system

pms-system
Fact-level verified

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 surveillance and vigilance system for the devices he is dealing with, including the elements listed in the rule.

Conditions
  • Duty falls on the licensee (manufacturer or importer); covers all devices the licensee deals with

Effective from 2018-01-16

Complemented by rule 19(8), which requires enlistment/registration holders to maintain indexed records on clinical investigations, literature, labelling errors, deterioration, batch failures, unexpected side effects and performance failures for new devices.

Official forms & portals

Which current form, portal, account, and submission package must be used?

Compare countries

MDMC licensing and registration applications are filed through the DRAP e-portal

mdmc-portal
Fact-level verified

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 legacy 'MDMC Licensing System (OLD)' for previously submitted license applications.

Conditions
  • Portal covers establishment licensing and device enlistment/registration workflows of the MDMC division

Statutory application formats remain the Forms under the rules (Forms 1-10, e.g. Forms 6/6A/7/7A for renewal under rule 16(1), Form-9 for import permits under rule 22(1)); the portal is the electronic filing channel.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

Compare countries

MDB inspects establishment premises through a panel of experts including inspectors or auditors

establishment-inspection-procedure
Fact-level verified

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, particulars, documents and other requirements, and may constitute a panel of experts which may include inspectors or auditors; a satisfactory inspection report is a condition of licensing.

Conditions
  • Applies to establishment licensing (manufacture and import); statutory QMS standard is set by rule 68 (international standards)

Effective from 2018-01-16

For foreign sites, see rules 15(2)-(3): devices from rule 67 reference authorities, WHO-prequalified or CE-marked are exempt from inspection of manufacturing units abroad.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

Compare countries

Export permit holders must withdraw non-conforming batches from export and recall issued units on MDB direction

export-batch-recall
Fact-level verified

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 direction, withdraw the remainder of that batch or lot from export and, so far as practicable, recall the issues already made from that batch or lot, and must maintain a record of all exports for each batch or lot. Rule 32(b) imposes the same withdrawal and recall duty on exporters generally for contraventions of the DRAP Act or the rules.

Conditions
  • Export-permit context; action on MDB or authorized-officer direction; recall duty is 'so far as practicable'

Effective from 2018-01-16

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

Applications may only be made by a licensed manufacturer or by an importer acting as authorized representative

applicant-eligibility
Fact-level verified

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 importer in his capacity as authorized representative in Pakistan holding a valid establishment licence.

Conditions
  • Foreign manufacturers cannot apply directly; they act through an importer-appointed authorized representative holding a valid import establishment licence

Effective from 2018-01-16

Class A devices are enlisted; Class B, C and D devices are registered

market-access-route
Fact-level verified

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.

Conditions
  • Applies to local manufacture and import alike; applicant categories fixed by rule 14(1)

Effective from 2018-01-16

Confirms baseline.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Pakistan approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Pakistan (5 records)

PakistanNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence
Pending verification
Statement

The import application forms require a free sale certificate from the country of origin attested by the Embassy of Pakistan as a mandatory document, and separately ask whether the product is on free sale in a rule 67 reference country. For a China-made device the NMPA-based free sale/export certificate satisfies the country-of-origin item; it does not satisfy the reference-country item and gives no abridged review.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

pakistan

China Classes In Scope

NMPA Class I filing / Class II-III certificate used as country-of-origin free-sale evidence; Pakistan Class A enlistment (Form 6-A) and Class B-D registration (Form 7-A) for import

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Form 7-A item (xiv) / Form 6-A item x: free sale certificate in the country of origin, embassy-attested
  • Form 7-A item (xv) / Form 6-A item xi: reference-country free sale certificate (rule 67) is a separate, additional item
  • Original agency agreement from the market authorization holder notarized in the country of origin (item (xiii)/ix)
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2018-01-16

Source passage: (xiii) Original Agency agreement from Market authorization Holder duly notarized from the country of origin. (xiv) Free sale certificate in the country of origin duly attested by Embassy of Pakistan. (xv) Whether the product is available on free sale in reference countries provided in rule 67 of Medical Devices Rules, 2017, Please attach original and valid free sale certificate duly attested by embassy of Pakistan.

PakistanWHO

Regulatory reference

Registration holder must inform MDB of foreign cancellation, suspension or loss of WHO prequalification

reliance-cancellation-notification
Fact-level verified

Under rule 15(4), where a medical device's registration is cancelled or suspended by the exporting country, or its WHO prequalification is cancelled, the Pakistan registration holder is bound to inform the MDB.

Conditions
  • Duty falls on the registration holder in Pakistan; triggered by exporting-country cancellation or suspension or WHO prequalification cancellation

Effective from 2018-01-16

PakistanAustralia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · US FDA · Austria · Belgium · Denmark · France · Germany · Ireland · Italy · Netherlands · Norway · Spain · Sweden · WHO · EU conformity assessment

Regulatory reference

Rule 67 lists reliance reference countries plus WHO prequalification and CE marking

reliance-reference-countries
Fact-level verified

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, Netherlands, Norway, Spain, Sweden, Switzerland and United Kingdom, or devices pre-qualified by the World Health Organization, or CE marked by conformity assessment bodies (CABs) notified in the NANDO database under the relevant European directive for medical devices, subject to evidence and supporting documents.

Conditions
  • Reliance subject to evidence and supporting documents

Effective from 2018-01-16

PakistanNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference
Pending verification
Statement

The Medical Devices Rules, 2017 reference-country clause names the USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and the United Kingdom, plus WHO-prequalified devices and CE-marked devices certified by NANDO-listed bodies. China/NMPA is not among them, so an NMPA certificate confers none of the reliance or foreign-inspection exemptions tied to that list.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

pakistan

China Classes In Scope

All classes (enlistment Class A, registration Class B-D)

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Reliance and rule 15(2)-(3) inspection exemptions apply only to the listed authorities/schemes
  • NMPA approval does not qualify
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2018-01-16

Source passage: ...enlisted or registered by the MDB or approved by any regulatory authority of USA, Japan, Australia, Canada, Austri[a]...

PakistanWHO · EU conformity assessment

Regulatory reference

Devices from reference authorities, WHO-prequalified or CE-marked devices are exempt from foreign manufacturing-site inspection

reliance-inspection-exemption
Fact-level verified

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 unit is located, and devices pre-qualified by the WHO or CE marked by NANDO-notified conformity assessment bodies are likewise exempt from foreign inspection, subject to evidence and supporting documents.

Conditions
  • Exemption applies irrespective of the manufacturing country of the site; subject to evidence and supporting documents

Effective from 2018-01-16

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

No authority-side decision deadline identified in the April 2022 consolidated Rules

clocks.no-authority-review-deadline
Pending verification

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. Rules 15(1) and 16(3) state that the Board considers the application and, if satisfied, enlists or registers the device. The identified time limits instead address applicant or respondent actions: renewal applications at least 60 days before expiry (rules 7(1) and 16(1)), appeals within 60 days (rule 60), show-cause replies within 15 days (rules 10(2) and 20(2)), and export-permit renewals three months before expiry (rule 30).

Conditions
  • Bounded to the April 2022 consolidated text; later amendments or separate DRAP procedures may affect the current position.

The source URL is DRAP's official consolidated PDF, but independent review could not retrieve its bytes from verification egress. The negative finding is therefore retained only as source-backed-partial and must not be treated as a verified statement about the complete current regime.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

MDB may grant emergency use authorization in public health emergencies, disasters and pandemics

emergency-use-authorization
Fact-level verified

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 calamity or pandemic, subject to such procedure, conditions and validity as may be determined by the Authority on the recommendations of the MDB.

Conditions
  • Triggered by public health emergency, national disaster, natural calamity or pandemic; procedure, conditions and validity determined by the Authority on MDB recommendations

Effective from 2022-04-27

Added vide S.R.O. 599(I)/2022 dated 27.04.2022 per the consolidating footnote.

Small quantities of devices may be imported in passenger baggage for exclusive personal use

personal-use-import
Fact-level verified

Under rule 24, small quantities of medical devices, including devices whose import is otherwise prohibited without enlistment or registration, may be imported for personal and hospital patients' use provided the device forms part of a passenger's bona fide baggage and is intended for the exclusive personal use of the passenger, with quantity restricted to personal requirement only.

Conditions
  • Passenger bona fide baggage; exclusive personal use; quantity limited to personal requirement; also covers hospital patients' use

Effective from 2018-01-16

Special access devices defined for emergency use or where conventional remedies failed or are unsuitable

special-access-definition
Fact-level verified

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 failed or are unavailable or unsuitable to meet any special needs arising in the course of his practice.

Conditions
  • Use confined to qualified practitioners; emergency or failed/unavailable/unsuitable conventional remedies

Effective from 2018-01-16

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

Compare countries

Testing standards for medical devices follow international standards

standards-international
Fact-level verified

Rule 68 provides that the standards for testing of medical devices shall be in accordance with the international standards; the rules do not name a mandatory local standard, and conformity evidence accepted elsewhere in the rules consists of ISO 13485, CE marking by NANDO-notified CABs, WHO prequalification and free sale certificates.

Effective from 2018-01-16

Distinct legal rule recorded as a fact in addition to the certification-atlas typed finding.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Appeals against MDB decisions lie to the Appellate Board within sixty days

appeal-60-days
Fact-level verified

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 Schedule C of the rules (PKR 50,000 as consolidated till April 2022; PKR 64,800 under S.R.O. 1399(I)/2025 row 132).

Conditions
  • Appeal window of sixty days from the MDB decision

Effective from 2018-01-16

For renewal refusals, rule 16(8) additionally requires the MDB to provide an opportunity of being heard and written reasons.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Practitioners must keep records of implanted devices including batch number

implant-records
Fact-level verified

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, the date of the procedure and the operator or surgeon, the name and description of the implant, and the lot or batch number of the implant; contravention is an offence punishable under the DRAP Act (rule 56(2)).

Conditions
  • Duty falls on the qualified practitioner, not the manufacturer; applies to implanted devices

Effective from 2018-01-16

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Foreign safety withdrawals, bans and adverse reactions must be reported to MDB within thirty days

foreign-safety-notification-30-day
Fact-level verified

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 in any of those countries, the manufacturer or importer must inform the MDB within thirty days of the information coming to his knowledge and take appropriate action within the shortest possible time. Under rule 19(12), any adverse reaction not included in the enlistment or registration application that is reported in any rule 67 country must be reported to the MDB within thirty days by the manufacturer or importer.

Conditions
  • Rule 19(10) applies where the related company holds approval in USA/EU/Canada/Japan/Australia; rule 19(12) applies to adverse reactions reported in any rule 67 reference country; thirty-day limits run from knowledge of the information

Effective from 2018-01-16

Batch failures, unexpected side effects and performance failures must be reported to MDB within fourteen days

vigilance-14-day-reporting
Fact-level verified

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 respecting failure of distributed batches to meet required specifications, unexpected side effects, injury, toxicity or sensitivity reactions, and unusual failure to demonstrate expected performance (rule 19(8) clauses (f), (g) and (h)).

Conditions
  • Fourteen-day outer limit; applies to records under rule 19(8)(f)-(h); reports in duplicate

Effective from 2018-01-16

Related structured datasets

Classification systems · 1 record
Open Risk classes A through D. →
Id

pakistan:medical-device

Jurisdiction Id

pakistan

Domains
  • medical-device
  • ivd
Name

Risk classes A through D.

Classes
  • Id

    a

    Label

    Class A

    Normalized Risk Level

    low

  • Id

    b

    Label

    Class B

    Normalized Risk Level

    medium

  • Id

    c

    Label

    Class C

    Normalized Risk Level

    high

  • Id

    d

    Label

    Class D

    Normalized Risk Level

    highest

Regulator

DRAP

Official Domains
  • dra.gov.pk
Source Status

official-source-verified

Source Title

Medical Devices Rules 2017 — annexed classification rules and rule 13

Source Url

https://www.dra.gov.pk/wp-content/uploads/2022/10/Medical-Devices-Rules-2017-updated-upto-april-2022-2.pdf

Verified On

2026-08-25

Source Supports
  • class-axis
  • classification-rules
Notes
  • Four classes where Class A represents the lowest hazard and Class D the highest; class determined by the hazard the device presents based on intended use and the technologies utilized (annex paragraphs (a)-(b)).
  • Class A follows the enlistment track and Classes B, C and D the registration track (rule 13).
Registration pathways, prior approvals and planning · 0 records

No maintained record.

Government fee schedules · 1 record
Open Pakistan fees →
Jurisdiction Id

pakistan

Country

Pakistan

Country Code

PK

Authority

DRAP

Low Risk Local
Min

6300

Max

6300

Currency

PKR

Per Product

Yes

High Risk Local
Min

64800

Max

64800

Currency

PKR

Per Product

Yes

Details
  • Id

    class-a-enlistment-local-or-import

    Item

    Class A enlistment - local manufacture or import

    Currency

    PKR

    Amount Local

    6300

    Amount Local Formatted

    PKR 6,300

    Frequency

    Per device; same row covers renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    accessory-local-manufacture

    Item

    Enlistment or registration - accessory or component, local manufacture

    Currency

    PKR

    Amount Local

    6300

    Amount Local Formatted

    PKR 6,300

    Frequency

    Per device; same row covers renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    class-b-import-registration

    Item

    Class B registration - imported device, accessory, or component

    Currency

    PKR

    Amount Local

    32400

    Amount Local Formatted

    PKR 32,400

    Frequency

    Per registration

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    class-b-import-registration-renewal

    Item

    Class B registration renewal - imported device

    Currency

    PKR

    Amount Local

    15700

    Amount Local Formatted

    PKR 15,700

    Frequency

    Per renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    class-c-d-import-registration

    Item

    Class C/D registration - imported device, accessory, or component

    Currency

    PKR

    Amount Local

    64800

    Amount Local Formatted

    PKR 64,800

    Frequency

    Per registration

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    class-c-d-import-registration-renewal

    Item

    Class C/D registration renewal - imported device

    Currency

    PKR

    Amount Local

    32400

    Amount Local Formatted

    PKR 32,400

    Frequency

    Per renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    class-b-c-d-local-manufacture-registration

    Item

    Class B/C/D registration - local manufacture

    Currency

    PKR

    Amount Local

    26100

    Amount Local Formatted

    PKR 26,100

    Frequency

    Per registration

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    class-b-c-d-local-manufacture-renewal

    Item

    Class B/C/D registration renewal - local manufacture

    Currency

    PKR

    Amount Local

    12500

    Amount Local Formatted

    PKR 12,500

    Frequency

    Per renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    establishment-licence-manufacture

    Item

    Establishment licence to manufacture medical devices

    Currency

    PKR

    Amount Local

    128500

    Amount Local Formatted

    PKR 128,500

    Frequency

    Per licence

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    establishment-licence-manufacture-renewal

    Item

    Establishment licence renewal - manufacture

    Currency

    PKR

    Amount Local

    64800

    Amount Local Formatted

    PKR 64,800

    Frequency

    Per renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    establishment-licence-import

    Item

    Establishment licence to import medical devices

    Currency

    PKR

    Amount Local

    26100

    Amount Local Formatted

    PKR 26,100

    Frequency

    Per licence

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    establishment-licence-import-renewal

    Item

    Establishment licence renewal - import

    Currency

    PKR

    Amount Local

    12500

    Amount Local Formatted

    PKR 12,500

    Frequency

    Per renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    appeal-appellate-board

    Item

    Application for appeal before the Appellate Board

    Currency

    PKR

    Amount Local

    64800

    Amount Local Formatted

    PKR 64,800

    Frequency

    Per appeal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    miscellaneous-application

    Item

    Miscellaneous application having commercial significance

    Currency

    PKR

    Amount Local

    9400

    Amount Local Formatted

    PKR 9,400

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    outsourcing-certificate

    Item

    Certificate to outsource manufacturing processes or analysis

    Currency

    PKR

    Amount Local

    64800

    Amount Local Formatted

    PKR 64,800

    Frequency

    Per contract acceptor

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

  • Id

    outsourcing-certificate-renewal

    Item

    Outsourcing-certificate renewal

    Currency

    PKR

    Amount Local

    32400

    Amount Local Formatted

    PKR 32,400

    Frequency

    Per renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Source Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Source Effective Date

    2025-08-01

    Verified On

    2026-08-25

Notes
  • S.R.O. 1399(I)/2025 applies from 1 August 2025.
  • Any change in particulars of an enlisted or registered device costs 50% of the registration/enlistment fee; changes to a licensed establishment cost 50% of the establishment-licence fee.
  • In-vitro cluster and system/family application options are tiered at PKR 26,100, 52,200, and 104,500 for up to 20 articles/devices/reagents plus per-extra-item charges of PKR 2,600 or 5,200, with renewals at 50%; the S.R.O. PDF text layer for those rows is partially column-scrambled, so row-to-amount mapping should be re-verified against the gazette print.
  • Schedule C of the Medical Devices Rules 2017 (historical, superseded) carried lower fees, e.g. Class C/D import registration PKR 50,000 and manufacture establishment licence PKR 100,000.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    DRAP S.R.O. 1399(I)/2025: revised regulatory fees for therapeutic goods

    Url

    https://www.dra.gov.pk/wp-content/uploads/2025/08/Revised-DRAP-Regulatory-Fee-for-Therapeutic-Goods-01.08.2025.pdf

    Effective Date

    2025-08-01

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Pakistan certifications →
Slug

pakistan

Market

Pakistan

Confidence

low

Schemes
  • Id

    pnra-radiation-facility-licence

    Name

    PNRA licence to operate a radiation facility or activity

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Facility Operator

    Note

    The Pakistan Nuclear Regulatory Authority states that all radiation facilities and activities in Pakistan must be licensed or authorised by PNRA, with licences issued after a detailed review of the applicant's submissions, under the PNRA Ordinance 2001 and the Regulations for the Licensing and Authorization of Radiation Facilities and Activities. The licence is issued to the person operating the facility, not to the equipment supplier.

    Source Urls
    • https://www.pnra.org/r-safety.html
    Source Binding

    candidate

  • Id

    pnra-import-noc-licensee-only

    Name

    PNRA No Objection Certificate for import, issued only to licensees

    Category

    Ionizing Radiation

    Status

    Mandatory At Import

    Object

    Importer Of Radiation Source

    Note

    PNRA regulations allow import or export of radiation sources — radiation generators as well as radioactive material — only where PNRA has explicitly authorised it through a No Objection Certificate, which is verified by law-enforcement agencies at entry and exit points and is mandatory for Pakistan Customs clearance. The commercially important constraint is that NOCs are issued to PNRA licensees only, so a foreign manufacturer cannot import in its own name: the importer and the facility licensee must be the same entity, or the consignment cannot move. PNRA distinguishes three instruments — a permit in a licensee's name to procure a source, an NOC in a licensee's name to clear a consignment, and a licence to operate the facility.

    Source Urls
    • https://www.pnra.org/r-safety.html
    Source Binding

    candidate

  • Id

    no-pnra-control-of-non-ionizing-equipment

    Name

    No PNRA control over non-ionizing equipment

    Category

    Non Ionizing Radiation

    Status

    Evidence Only No Separate Certificate

    Object

    Non Ionizing Medical Equipment

    Note

    An express negative from the regulator rather than an inference: PNRA states that MRI, ultrasound and ECG apparatus require no registration or licensing from PNRA because they do not emit ionizing radiation. Pakistan's nuclear regulator therefore has no hold over non-ionizing medical equipment, and the DRAP registration is the only route for it.

    Source Urls
    • https://www.pnra.org/faqs.html
    Source Binding

    reviewed

  • Id

    drap-electrical-emc-evidence

    Name

    DRAP electrical/EMC evidence

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    No local certification scheme: testing standards follow international standards (Medical Devices Rules 2017 rule 68); recognized evidence includes notarized ISO 13485 (for customs release), free sale certificates from the country of origin, declarations of conformity, CE-marking certificates from NANDO-notified conformity assessment bodies and WHO prequalification (rules 15(3), 52(1) proviso, 67).

    Source Urls
    • https://www.dra.gov.pk/wp-content/uploads/2022/10/Medical-Devices-Rules-2017-updated-upto-april-2022-2.pdf
    Source Binding

    candidate

  • Id

    pta-terminal-equipment-type-approval-certificate

    Name

    PTA terminal-equipment Type Approval Certificate

    Category

    Telecom Network Attachment

    Status

    Mandatory If Feature

    Object

    Covered Terminal Equipment

    Source Urls
    • https://tipp.gov.pk/index.php?id=104&r=searchProcedure%2Fview1
    Source Binding

    candidate

Official Sources
  • Authority

    PNRA (Pakistan Nuclear Regulatory Authority)

    Topic

    radiation safety — facility licensing and import/export authorisation of radiation sources

    Url

    https://www.pnra.org/r-safety.html

  • Authority

    PNRA (Pakistan Nuclear Regulatory Authority)

    Topic

    FAQs — permit, NOC and licence distinguished; non-ionizing apparatus need no PNRA authorisation

    Url

    https://www.pnra.org/faqs.html

  • Authority

    PTA (Pakistan Telecommunication Authority)

    Topic

    type approval under s 29 of the Telecom Act 1996 and the standards regulations

    Url

    https://www.pta.gov.pk/category/type-approval-3302477-2023-05-30

  • Authority

    Pakistan Trade Information Portal

    Topic

    PTA terminal-equipment type approval

    Url

    https://tipp.gov.pk/index.php?id=104&r=searchProcedure%2Fview1

  • Authority

    DRAP

    Topic

    Medical Devices Rules 2017 international testing standards and recognized certificates

    Url

    https://www.dra.gov.pk/wp-content/uploads/2022/10/Medical-Devices-Rules-2017-updated-upto-april-2022-2.pdf

Keep researching this market

More Pakistan medical device resources

View the Pakistan resource hub →
Compare regulatory data across all countries →
Continue with this market
DJ Fang
Need to apply Pakistan's requirements to a product?
Confirm the current DRAP pathway, evidence, and local-role details for the actual device before filing.
Pricing