DRAP · structured requirements

🇵🇰 Pakistan IVD regulatory data

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

2 facts1 dimensions1 official sourceslatest verification 2026-09-15

Changes after registration

Common questions about changing a registered IVD in Pakistan. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

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 (2 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.

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]...

Related structured datasets

Classification systems · 1 record

Open Risk classes A through D. →

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

No maintained record.

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Pakistan fees →

Jurisdiction Id

pakistan

Country

Pakistan

Country Code

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

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