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 Registration of Medical Devices
Companies want
extension in date to meet
DRAP documentation

KARACHI: Healthcare companies dealing in medical devices has urged the Government to extend the time period for meeting all documentation requirements for registration with DRAP. They maintain that at present numerous application for registration are still pending with DRAP and they also need time to get all related documents from their principals overseas which is also taking sometime. Since the deadline for complying with this documentation is nearing, it may lead to shortage of such medical devices and diagnostic products, they fear.

It may be mentioned here that Medical Devices Rules – 2017 notified on 16th January, 2018 aims to regulate Medical Devices & Diagnostic Industry to meet International Standards Practices and require all Products Registration with DRAP. The timeline of exemptions from the operations of the Rules as mentioned under Rule 52 is close to expire, while most of the importers specially small & medium size are still in process to complete the requirements of documentation.

According to reports so far two thousand two hundred forty seven applications have been submitted for registration and the number of products registered so far are only 847. The process is also slow because it requires lot of documentation needed to fulfill the registration requirements as well as heavy cost of documentation.

Companies dealing in medical devices and diagnostic products maintain that it was taking more time than their expectation to get complete dossier from their principals / manufacturer the registration dossier according to Form 6A & 7A because of continuous changes in International/EU Regulatory Medical Device Rules besides requirement of documents attestation was also taking much more time than expected.


PM&DC completes inspection
of medical, dental colleges

ISLAMABAD: Pakistan Medical & Dental Council is reported to have completed the inspection of all the private and public medical and dental colleges and final recommendations based on the inspection report are now being finalized. This time the inspection, it is learnt, was very comprehensive and professionals were involved in different related fields as well to look at the buildings, structure, and equipment. Faculty, teaching and other training facilities.

In the meantime the fate of the PM&DC ordinance hangs in balance and if it is not approved by the Senate, next month, the situation may get complicated. The Ordinance gives sweeping powers to the committee nominated by the Prime Minister while no aggrieved party will be able to go to the Courts to get justice.

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