|Unnecessary requirements for renewal of registration for health care devices eliminated|
|Reform Description||Before: Healthcare devices used to be registered after going through numerous checks and a detailed scrutiny which were based on large number of documents. At the time of renewal similar exercise was repeated.
After: Registration and renewal is made easier by introducing simpler forms and removing various attachments which were required earlier.
|BeneficiariesAutomotive Owners||All businesses in healthcare sector|
|Jurisdiction/ Location||Federal (Entire Pakistan)|
|Department||Ministry of National Health Services Regulation and Coordination (MoNHSR&C) / Drug Regulatory Authority of Pakistan (DRAP)|
|Date of Implementation||18-03-2022|
|Details||Difficulty||Healthcare devices were initially registered after a cumbersome procedure which involved inspections of the relevant documents. This was also the case at the time of renewal, as several documents had to be attached again along with the registration renewal request.|
|Analysis||The process had caused difficulties to the healthcare devices manufacturers as it took a lot of time and added more burden on businesses in terms of compliance cost & hassle.|
|Solution||DRAP has now introduced separate simplified forms for renewals and removed the unnecessary requirements by introducing form 6A which requires a little information.|
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