Import, export of medical devices: DRAP regional offices get NOC issuance powers

Islamabad: In a bid to facilitate patients and the industry, the newly-formed Medical Devices Board of the Drug Regulatory Authority of Pakistan (DRAP) has authorised the authority’s regional offices to issue no objection certificates for the import and export of small quantities of medical devices for personal use as well as raw material or finished medical devices.

The development occurred during the maiden meeting of the board, which is responsible for the enlistment or registration of medical devices, licensing of establishments and issuance of permits for export and import of medical devices and dealing with the relevant matters.

The board came into being after the promulgation of the Medical Devices Rules, 2017.

The meeting was told that the Medical Devices Rules, 2017, were more practical than previous rules.

It asked a committee headed by expert Muhammad Tahir Aziz with more than 20 years experience in hospital pharmacy and procurement to prepare the Adverse Event Form (AEF) for medical devices to be filled by the importers, distributors and manufacturers.

Tahir Aziz presented the AEF form before the board for examination. The board appreciated the efforts made for the purpose.

It also formed a committee to prepare advisory for the provincial governments to either change the title of the drug sale licence to therapeutic goods sale licence or introduce new licences for the sale of medical devices.

Meanwhile, the DRAP and Punjab health department has decided to form a joint task force to implement a harmonised drug regulatory framework. The decision was made during a meeting between DRAP CEO Dr Sheikh Akhter Hussain and Punjab health minister Khawaja Imran Nazir.

The meeting took place to discuss ways to increase coordination between the DRAP and health department for effective enforcement of the Drugs Act, 1976 and DRAP Act, 2012.