The Workbench · Craft
Pakistan enlists Class A devices; it registers the rest
This blog has already covered how India forks its own device licensing by class rather than by whether the device is imported, and how Indonesia opens a device's own file on two separate certificates instead of one. Pakistan's Medical Devices Rules, 2017 draw their own class line in a third way: not a second certificate, and not a separate licensing track by origin, but two different words for two different depths of review, assigned by the same Board, off the same classification the device already carries.
One Board, two different words for approval
The Medical Devices Rules, 2017 — notified by Pakistan's federal government following a Supreme Court matter over unregistered and substandard cardiac stents — put the Medical Device Board in charge of both outcomes a device's own file can reach. Under the rules' own Chapter IV, the Board handles enlistment for Class A medical devices, and registration for Class B, C, and D medical devices. Both outcomes run through the same Board, off the same four-class system, and both end with the device able to carry a number validating that it cleared DRAP's process — but “enlistment” and “registration” aren't two names for the same review at two speeds. They're the rules' own way of marking which depth of review a given class actually got.
The line sits at Class A, not at any other boundary
Pakistan's four device classes run ascending risk, from Class A devices like tongue depressors, disposable masks, and manual surgical instruments, up through Class D devices like heart valves and implantable defibrillators. The enlistment-versus-registration line sits at exactly one point on that scale: Class A gets the lighter enlistment track, and everything from Class B up — including the mid-risk Class B and C bands, not just the highest-risk Class D — goes through full registration instead. A file that assumes only the highest class draws full scrutiny, and that B and C devices get some intermediate treatment of their own, has misread where the rules actually cut the distinction.
The applicant's own status decides the form, not just the class
Class alone doesn't finish the filing question, because the rules also fork on who's applying. A local manufacturer holding a valid manufacturing licence applies for Class A enlistment on Form-6, while an importer standing in as the device's local authorized representative, holding its own establishment licence, applies on Form-6A instead. The same split carries into registration: Form-7 for the local manufacturer, Form-7A for the importer. A device's own filing checklist needs both facts recorded before the right form gets picked — the class it falls into, and which of the two applicant types is actually submitting on its behalf.
The label doesn't announce which track a device came through
Rule 38 requires a device's own label to carry licence details along with “an enlistment or registration number” — language that treats the two numbers as functionally interchangeable on the label itself, however differently they were earned behind the scenes. A distributor or importer reading a label downstream has no way to tell, from the number alone, whether the device behind it went through the Board's lighter Class A review or its full Class B-through-D registration. That's a detail a supply-chain file has to carry on its own, sourced back to the device's own classification record, because the market-facing document was never built to disclose it.
A multi-year transition still shapes files already on record
The rules didn't take effect all at once for devices already on the market when they were notified in January 2018. DRAP's own 2021 extension notice set a staggered transition running by class — Class D by 31 March 2022, Class C by 30 June 2022, Class B by 30 September 2022, and Class A by 31 December 2022 — giving firms with devices already in distribution a graduated runway to bring each class's paperwork current rather than requiring every device enlisted or registered on day one. Those deadlines have since passed, but a legacy device's own file still ought to show which transition date it was brought current against, not just the enlistment or registration number it landed on.
Where this meets the file
A Pakistan market-access tracker needs two fields the device's own label number can't supply on its own: the class that decided enlistment versus registration, and the applicant type — local manufacturer or importer-as-representative — that decided which form carried the filing. A DRAP filing worksheet built around that split, alongside the launch catalog's other market-access templates, is previewed there now. If your team tracks this differently, the shelf takes that correction directly.
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