Explore the medical device requirements currently available for Pakistan, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
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.
Confirms baseline.
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.
Confirms baseline. A parallel late-renewal rule applies to establishment licences (rule 7).
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.
Confirms baseline.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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.
Corrects baseline: the rules do not contemplate a new-registration outcome for changes; variation with prior approval is the single route.
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.
Corrects baseline.
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)).
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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).
Confirms baseline.
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)).
Confirms baseline for representative/particulars changes: the mechanism is a prior-approval variation, not a new registration.
Which current law, regulation, guidance, and transition provisions apply?
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 Pakistan Act, 2012 (XXI of 2012) with the approval of the Federal Government, and came into force at once upon publication.
The consolidated PDF used is 'As amended till April 2022', footnoting amending instruments S.R.O. 526(I)/2021, 1500(I)/2021, 430(I)/2022 (Forms 6A/7A), 559(I)/2022 and 599(I)/2022.
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 devices and the activities covered by the 2017 Rules, except notification No.F.5-11/2017-SO (Admn) dated 15 March 2017, which survives.
Is the product a device, IVD, accessory, software, or borderline product locally?
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.
Which registration, notification, listing, reliance, or conformity route applies?
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.
Confirms baseline.
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.
Which foreign decisions or evidence can be reused, with what effect and conditions?
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.
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.
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.
Which establishment licences, importer permissions, and distribution controls apply?
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).
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.
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.
Inserted vide S.R.O. 559(I)/2022 dated 27.04.2022 per the consolidating footnote.
Which evidence, local deltas, formats, and signatures are required?
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.
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.
Which current form, portal, account, and submission package must be used?
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.
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.
Which label and IFU elements, languages, symbols, and translation controls apply?
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.
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.
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.
Which QMS, audit, inspection, and certificate scope is accepted or required?
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.
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.
Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?
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.
Distinct legal rule recorded as a fact in addition to the certification-atlas typed finding.
What regulator fee applies to this class, route, event, and date?
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.
Preserves the superseded instruments as part of the succession; the historical Schedule C amounts are recorded in the government-fees typed findings.
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.
S.R.O. 1399(I)/2025, closing paragraph: 'The fee deposited for any regulatory service shall in no case be refunded.'
Which UDI, device listing, database, and traceability duties apply?
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)).
Which clinical or IVD performance evidence or study is required and accepted?
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)).
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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.
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.
Added vide S.R.O. 599(I)/2022 dated 27.04.2022 per the consolidating footnote.
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.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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.
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.
What is reportable, by whom, where, in what format, and by what deadline?
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)).
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.
Which recall, FSCA, notice, and authority-coordination duties apply?
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.
Which claims, audiences, channels, approvals, and restrictions apply?
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).
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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).
For renewal refusals, rule 16(8) additionally requires the MDB to provide an opportunity of being heard and written reasons.
What review, validation, and applicant stop-clock rules apply?
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).
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.
