Check a Refurbished Medical Device Is DRAP Registered in Pakistan: Label, Dates and Banned Types
DRAP's 2026 rules say a refurbished medical device must be enlisted or registered, labelled Refurbished with 2 dates, and never single-use. Check it first.
Short answer: Since 1 September 2026, a refurbished medical device sold in Pakistan must be enlisted or registered with the Drug Regulatory Authority of Pakistan (DRAP). Its label must say "Refurbished" and show the refurbisher's name, licence number, original manufacture date and refurbishment date. Single-use, implant and disposable devices can never be refurbished.
Refurbished machines are common in Pakistani clinics. An ultrasound, an X-ray unit or a patient monitor bought second hand can cost far less than a new one. DRAP has now issued regulations just for them, and a buyer can check most of what they require by reading the label.
We read DRAP's notification S.R.O. 1450(I)/2026, the Medical Devices (Refurbishment) Regulations, 2026, on dra.gov.pk on 20 October 2026. It is dated 1 September 2026 and says it came into force at once. Here is what it requires, and what a clinic or buyer should check.
Refurbished devices now need DRAP enlistment or registration
The regulations say DRAP's Medical Devices Board will enlist or register refurbished devices. Low-risk Class A devices are enlisted. Higher-risk Class B, C and D devices are registered. Only a licensed local manufacturer or a licensed importer acting for the foreign refurbisher can apply.
In plain words, the person who sells you a refurbished device should be able to show a DRAP certificate for it. The regulations give that certificate its own format: Form-5R for local refurbishment and Form-6R for imports.
| Device class | What DRAP does | Application form |
|---|---|---|
| Class A, lowest risk | Enlistment | Form-1R (local) or Form-2R (import) |
| Class B, C or D | Registration | Form-3R (local) or Form-4R (import) |
| Certificate issued | Proof of enlistment or registration | Form-5R (local) or Form-6R (import) |
To check the company itself, see whether it holds a DRAP establishment licence. Our page on checking a medical device importer or maker shows where DRAP lists those licences.
The label must say "Refurbished" and show two dates
The regulations set out what a refurbished device's label must carry. The word "Refurbished" must appear prominently on the device itself, with a new catalogue or code number. The label must name the refurbisher and its licence number, and give both dates.
- Look for the word "Refurbished" on the device itself, not only on the box or invoice.
- Find the new catalogue or code number. It should differ from the original model number.
- Read the name and address of the refurbisher, and its establishment licence number.
- Check the original manufacturing date and the refurbishment date. Both must be shown.
- Ask the seller for the DRAP enlistment or registration certificate for that model.
- Ask for the refurbishment certificate, which says the work followed DRAP's good refurbishment practices.
The two dates matter most. A machine made many years ago and refurbished last month is a very different purchase from one made two years ago. The regulations also say devices must meet DRAP's age profiling guidelines, which deal with the age of devices.
Single-use, implant and disposable devices can never be refurbished
The regulations say single-use, implantable and disposable medical devices shall not be refurbished. DRAP may add more device types to a banned list later. A refurbished syringe, catheter or implant is therefore not a legal refurbished product at all.
That rule protects patients most directly. Single-use items are made to be thrown away. Cleaning and reselling them is not refurbishment. If you are offered one as refurbished, do not buy it, and report the seller to DRAP.
The same caution applies to everyday disposables. Our report on checking syringes at a clinic covers the syringe batches DRAP has recalled this year.
Radiation machines need a PNRA calibration first
Every radiation-emitting device refurbished in Pakistan must be calibrated by the Pakistan Nuclear Regulatory Authority (PNRA) before its final quality release. That covers machines such as X-ray units. The application forms also ask for a PNRA report or certificate for any radiation device.
The regulations also require a technical file for each model, a declaration of conformity, a test report and a refurbishment certificate. A local refurbisher must have trained staff, a workshop with calibrated test tools and the ability to give after-sales service and spare parts for the long term.
After-sales service is a fair question for any buyer. Ask who will repair the machine, how quickly, and whether spare parts are in stock.
A used device is not the same as a refurbished one
The regulations define a used medical device as one that was in clinical service, then taken out for restoration. They say a used device is not a refurbished device under the rules. Refurbished means restored under DRAP's process, with a label and certificate to show for it.
Remanufacturing is different again. If a device is redesigned or changed so much that its specification or use changes, the regulations treat it as a new manufacture under the general rules, not a refurbishment.
DRAP can suspend or cancel a refurbished device's registration if it is unsafe, if its benefits no longer outweigh its risks, or if the licence was obtained by fraud. The holder gets a show cause notice and 15 days to reply first. For imports, DRAP's newer filing rules are in our report on medical device imports through PSW.
Common questions
Do refurbished medical devices need DRAP approval in Pakistan?
Yes. Since 1 September 2026, DRAP's Medical Devices Board enlists Class A refurbished devices and registers Class B, C and D devices.
What must the label of a refurbished device show?
The word "Refurbished", a new catalogue number, the refurbisher's name, address and licence number, the original manufacturing date and the refurbishment date.
Can a single-use device be refurbished?
No. The regulations ban refurbishing single-use, implantable and disposable devices. DRAP may add more types to that list.
Who can apply to register a refurbished device?
A licensed local manufacturer, including an authorised third-party refurbisher, or a licensed importer acting as the foreign refurbisher's representative in Pakistan.
Do X-ray machines need anything extra?
Yes. Radiation-emitting devices refurbished in Pakistan must be calibrated by the PNRA before final release.
Is a used device the same as a refurbished one?
No. The regulations say a used device is not a refurbished device. Only one restored under DRAP's process, with the label and certificate, counts.
How we verified this
What we checked, where we read it, and what we could not confirm.
We read DRAP's notice of S.R.O. 1450(I)/2026 and the regulations PDF on 20 October 2026. The PDF is a scanned copy marked for the Gazette, and a few words were unclear in our text reading. We could not find a public list of registered refurbished devices, DRAP's age profiling guidelines or the banned list it mentions, so we have not quoted any.
About the author
Public Services and Education Journalist
Fajr Riaz is a journalist and content writer at Pakistan Era, based in Lahore. She covers the questions people meet in everyday life in Pakistan: how a public service works, what a change in the rules means, and where to find a reliable answer.
