1.
Medical devices in Pakistan are governed by the Medical Device & Medicated Cosmetics (MDMC) Division of Drug Regulatory Authority of Pakistan .
Determine the classification of your medical device according to Schedule A of Medical Device Rules 2017.
Appoint a registered importer to bring your device into Pakistan.
You may now begin marketing your device in Pakistan. Registrations do not expire for a period of five years unless earlier suspended or cancelled.
No registration required. All
Class A devices must be enlisted
in the Medical Device Register
by the local manufacturer or
local importer.
For systems, product families or other multi-component devices, determine your most
favorable grouping strategy according to Schedule B of Medical Device Rules 2017.
Appoint an Authorized Representative to coordinate and submit your device registration application to the MDMC.
Prepare Submission Dossier using FORM-6A (For Class-A) and FORM-7A (For Class B,C & D)
format. Provide proof of compliance with reference market’s.
Authorized Representative submits application . Pay fee.
MDB grants approval and entered it in the Medical Device Register (MDR).
Devices approved for sale in one or more reference markets (Australia, Canada, Europe, Japan, Ireland, Italy,
Netherlands, Norway, Spain, Sweden, Switzerland and United Kingdom or the USA) qualify for an Immediate,
Expedited, or Abridged submission process.*
Medical Device Board (MDB) verifies classification and performs detailed evaluation of your application.
Class A Class CClass B Class D
Pakistan
The Regulatory Process for Medical Devices
* These alternate submission routes may cut as much as 50 calendar days off the review times.
This is a simplified overview of the process. The MDB frequently requests additional information after submission, which adds time to the approval process.

2.
Notes
1. These timelines start when the initial dossier is submitted to MDMC until final approval is granted. MDB often requests additional information after submission and we have
taken this into account. They also assume your device does not contain animal tissue, medicinal substances or employ entirely novel technology. The length of review will
depend on the quality and completeness of your technical documentation and how much time you take to address additional information requests from MDB after
submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE.
2. Registrations do not expire as long as the renewal is applied and fee is paid and you do not make any changes to the device, intended use, or indications for use. Note that there
is Post Registration change notification process and MDB grants approval of changes. Failure to apply for renewal and pay the renewal fee will result in your registration being
suspended.
3. The device registration expire after five year, so renewal is required. However, you must continue to pay your renewal fee.
4. Above rating of the complexity of the registration process is based on experience and the opinion of QA/RA professionals who were asked to rate the difficulty of registering a
device in country.
5. MDMC Fee in PKR for a single device registration. Class A Enlistment (Local Manufacturer or importer) = PKR 5,000; Class B,C&D (Local Manufacturer) = PKR 10,000; Class
B (Importer) = PKR 25,000; Class C & D (Importer) = PKR 50,000;. Costs assume you already have approval for your device in Australia, Canada, Europe, Japan or the United
States. Does not include cost of auditing a quality management system of foreign manufacturer.
Device classification
in Pakistan 
Class A Class B Class C Class D
Non-sterile
and Sterile
Product of
Reference Countries
Product of non
Reference Countries
Product of
Reference Countries
Product of non
Reference Countries
Product of
Reference Countries
Product of non
Reference Countries
How long you should
expect to wait after
submission until
approval is granted.1
<2 month <3 month 5-7 months 6-8 months 8-10 months 6-8 months 8-10 months
Validity period for device
registrations.2
5
Years
5
Years
5
Years
5
Years
5
Years
5
Years
5
Years
Renewal fee should be paid
this far in advance.3
2 months 2 months 2 months 2 months 2 months 2 months 2 months
Complexity of the
registration process for
this classification.4
MDMC Fee of gaining
regulatory approval.5
Time, Cost, and Complexity of Registration
SimpleSimpleSimpleSimpleSimpleSimpleSimple ComplexComplexComplexComplexComplexComplexComplex
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