CMC


New medical devices rules approve


Medical Devices Rules 2017, approved by the federal government in the cabinet meeting held on December 26, will come into effect when the Drug Regulatory Authority of Pakistan notifies them.

The scenario of spurious, and expired medical devices will finish by the new rules, these devices would be registered and regulated. The one that are not registered will be penalized.

A Medical Devices Board will perform assessment and evaluation for the new rules. The board will comprise representatives of federal and provincial governments along with experts from the field of medicine, biomedicine, software, electromechanical engineering and pharmacy.

In term of the process of registration of medical devices, the fee structure has been revised. Technical documentation requirements for registration have been minimised, if imported from reference countries including USA, European Union, Japan, Canada and Australia. The classification and grouping of medical devices has been harmonised with international guidelines of WHO, International Medical Devices Regulators Forum (IMDRF) and Asian Harmonisation Working Party (AHWP).

Now you can register on the DRAP official website for online registration of cardiac stents. The registry has also been established for companies seeking establishment licence. 


Sources <https://tribune.com.pk/story/1594642/2-cabinet-approves-new-medical-devices-rules/​>