Operation under Medical Devices Rules: LCCI urges DRAP to grant exemption to local manufacturers

The Lahore Chamber of Commerce & Industry (LCCI) has appealed to the Drug Regulatory Authority (DRAP) to grant exemption to the local manufacturers of Class-A medical devices from the operation of article 52 of the Medical Devices Rules 2017 notified through SRO No. 32(I)/2018.

In a letter written to the DRAP CEO, the LCCI President, Irfan Iqbal Sheikh, said that in the wake of COVID-19, there is insufficient availability of personal protective equipment (PPE) for healthcare personnel in the healthcare sector.

"Pakistan's local manufacturers in many sectors have geared up [efforts] to supplement the government's efforts by manufacturing the PPE as per DRAP categorization. There is also an emerging opportunity to export these PPE's (Class A/low hazard) devices to fetch much needed forex for the country."

In order to procure Class-A devices, local manufacturers need to be registered as an establishment with DRAP, he said, adding: "To fulfill the local needs, other countries/regulators have exempted their rules to help strengthen the nation's public health protection against COVID-19 threats by ensuring the availability and use of these medical devices."

The LCCI president requested DRAP to exempt local manufacturers of Class-A medical devices from operation of article 52 of the Medical Devices Rules 2017 notified through SRO No 32(I)/2018 for the period of emergency or for 24 months, whichever is later, from 16 January 2020 onwards.