Medical device registration with DRAP, done right the first time.
Enlistment, registration, establishment licences and deferral responses under the Medical Devices Rules, 2017. We prepare the dossier, file it, and follow it until the certificate is in your hand.
- Gap review complete2 documents requested from manufacturer
- Dossier filed on MDMCApplication and fee submitted
- Query answeredLabelling clarification
- Placed before Medical Device BoardAwaiting decision
- Registration certificateValid for 5 years
Illustration. Actual timelines depend on DRAP.
What DRAP requires, in one screen
The essentials of the Medical Devices Rules, 2017 that decide how your file is handled. Worth knowing before you sign a new principal.
Class A is enlisted. B, C and D are registered.
Devices are classed by risk. Class A goes through the simpler enlistment route; everything above it needs full registration, with more evidence as the class rises.
Rule 13No establishment licence, no product file.
An importer needs a DRAP establishment licence to import (applied on Form-2) before its products can be enlisted or registered. Manufacturers apply on Form-1.
Rules 3 and 4Validity of enlistment and registration certificates. Missing a renewal can stop you selling mid-tender.
Rule 15(4)Labels may be in English, but devices meant for home use also need Urdu. A common cause of queries.
Rule 41Licence holders must run post-market surveillance: distribution records, complaints, vigilance reporting and recalls.
Rule 49Is your file ready for DRAP?
A free two-minute check. Pick the device class, tick what you already have, and see your route and what's missing.
- Know whether you need enlistment or registration
- See the gaps before DRAP does
- Send the result to us and get a fixed quote
1Device class
2Documents you already have
Services, and exactly what you get
Take one service or hand over the whole portfolio. Every quote is fixed per product or per project.
Enlistment and registration
Classification, dossier compilation and filing on MDMC for Class A to D, then follow-up to the Board's decision.
Establishment licence
Import licence applications with the premises, storage and SOP documentation DRAP checks at inspection.
Deferral rescue
Already deferred? We break down what the Board asked for, get the right papers from the manufacturer, and reply properly the first time.
Renewals and variations
We track every expiry across your portfolio and file renewals and changes well before the deadline.
Pre-filing dossier audit
A document-by-document check against DRAP requirements, before you file rather than after a deferral.
QMS, GDPMD and vigilance
Distribution practice SOPs, complaint handling, recall procedures and the post-market records Rule 49 expects.
Why files get deferred, and how we prevent it
Most deferrals come down to a handful of avoidable document problems. We check for every one of these before filing.
Expired or wrong Free Sale Certificate
We check issue date, issuing authority, and that it names the exact model.
Authorisation letter doesn't match
We check it names your company, the legal manufacturer and the devices, exactly as filed.
ISO 13485 doesn't cover the site
We check the certificate's scope and address against the actual manufacturing site.
Wrong class claimed
We check classification against intended use before you commit to a route.
Labels don't match the dossier
We check model names, manufacturer details and Urdu text for home-use devices.
Missing evidence for the class
We check that Class C and D files carry the clinical and test data the Board expects.
How working with us goes
Send your product list
Device names, manufacturer and what you need. WhatsApp is fine.
Free gap review
We tell you your route, what's missing, and a fixed quote.
We prepare and file
Dossier compiled, checked and submitted on MDMC.
We follow to approval
Queries answered, updates at every step, certificate delivered.
Who's behind RegBridge
RegBridge is run by a licensed PharmD pharmacist who works on DRAP medical device files every day, on the importer's side of the table.
That means we know what a deferral letter is really asking for, which manufacturer documents cause trouble, and how to keep a file moving. Your principals, products and prices stay confidential, and we're happy to sign an NDA first.
Questions distributors ask
Something else? Ask us on WhatsApp.
How long does registration take?
It depends on the class, how complete your documents are, and when the Medical Device Board meets. After the gap review we give you a realistic estimate, not a hopeful one.
Our product was deferred. Can you take it over?
Yes. Send the deferral letter and what was filed. We'll tell you what the Board needs and what the manufacturer has to provide.
Do we need an establishment licence first?
Yes. Under the Rules, you need a DRAP establishment licence to import before your products can be enlisted or registered. We can handle that application too.
How do you charge?
A fixed fee per product or per project, quoted after the free gap review. DRAP's own fees are separate and paid to DRAP.
Can you deal with our manufacturer directly?
If you like. Many clients copy us into emails with the principal so documents come straight to us in the right format.
Will you keep track of our renewals?
Yes. Send us your registered products and we'll keep an expiry calendar and remind you well before each 5-year renewal is due.
Send us your product list
We'll reply with your route, what's missing and a fixed quote, usually within one working day.
Monday to Saturday, 10am to 7pm. Based in Lahore, working with clients across Pakistan.