Medical Device Reporting rules to impact exports


Federal Minister for Industries and Production Makhdoom Syed Murtaza Mahmood has assured the surgical instruments industry of his all-out support for resolving their issues and facilitating them.

He made the remarks during his visit to the Surgical Instruments Manufacturers Association of Pakistan (SIMAP) office in Sialkot.

Mahmood underlined the need for taking on board all relevant organisations like the Ministry of Science and Technology, Ministry of Commerce and the departments concerned for an early resolution of issues pertaining to the Medical Device Reporting (MDR) Regulations. The rules will come into force by 2024 and may seriously affect exports of the sector if compliance is not ensured by the industry.

The minister declared that the government would seek the possibility of negotiating with the international certification bodies to provide MDR solutions to Pakistan’s industry. He told the industry to identify two to three medical devices for reverse engineering and local manufacturing with the support of ministry-affiliated organisations.

The minister called for reviewing the existing rules and regulations of Export Processing Zones Authority (Epza) and Special Economic Zones (SEZs) to make them more industry-friendly and increase ease of doing business. He advised all government departments to work with the industry to solve the problems faced by the surgical goods manufacturers in order to increase their exports. Speaking on the occasion, Engineering Development Board Chairman Almas Hyder briefed meeting participants about the working of the industries ministry-related organisations to address the issues being faced by the sector to improve efficiency, productivity and diversify exports.

Hyder believed that it was high time that the industry upgraded its instrument manufacturing technology to hi-tech manufacturing and become a hub of medical devices. He requested industry stakeholders to identify the required technologies as the ministry would facilitate the transfer of modern technology.

SIMAP president emphasised that the industry needed the government’s support for identifying joint venture partners from China for technology transfer to boost the manufacturing of medical devices and appliances.

Published in The Express Tribune, September 23rd, 2022.

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