TDAP asks surgical instrument industry to comply with EU regulations

KARACHI: The Trade Development Authority of Pakistan (TDAP) has urged the manufacturers and exporters of surgical instruments to comply with the regulations and requirements of the European Union, as lack of technological advancement restricts Pakistan’s potential in terms of exports.

“There is a need to sensitise the exporters about the European Union requirements such as ISO Certifications, medical devices directives pertaining to quality and labelling etc,” a report prepared by the authority noted.

Europe has in place strict quality requirements for surgical instruments being imported from the world.

Industry associated with the surgical sector, especially SMEs do not have ISO and Current Good Manufacturing Practices (CGMPs) Certifications to allow their products market access to Europe.

“Besides, Pakistani exporters are facing stiff competition from countries like China, Mexico etc due to cheap labour and technological innovation,” the TDAP report said.

The report notes that unlike competitors, Pakistan has no renowned brands in the international market. Resultantly, the buyers for Pakistani products were mostly distributors and wholesale dealers who sold these products under their own brand names. Also, companies do not have the resources to establish their own distribution networks in the European markets.

“Pakistani exporters are still manufacturing traditional products. There is a huge market for production of instruments through other materials such as plastics and synthetics,” the report added.

Europe is one of the largest markets for imports of surgical instruments from the world. The total import of surgical instruments by European Union in 2017 was euro 16.25 billion, which was 1.08 percent higher than imports in 2016.

According to estimates, the market would continue to grow with increasing demand for safe, cost and time effective solutions.

According to Pakistan Bureau of Statistics, Pakistan’s surgical goods exports clocked in at $253 million during July-February of 2018-19.

“Despite having the raw materials, skilled labour force and competencies, the surgical industry of Pakistan has not been able to fully capitalise on the potential of its exports,” the report added.

An official said the Commercial Section in Belgium had recommended a delegation of surgical instruments’ exporters to Europe to help them understand the requirements of European markets and establish direct linkages with the importers.

The Commercial Section also recommended the ministry and TDAP to organise seminars with the support of Surgical Instruments Manufacturers Association of Pakistan (SIMAP) to sensitise the surgical industry especially the small firms.

“Through public-private partnership, the surgical industry must focus on research and development, which can adapt to new methods of production, and develop new products that are made out of plastics and synthetic material,” the report noted.