ISLAMABAD-Surgical goods exports to European markets may be halted by the middle of 2024 as a new Medical Device Regulation (MDR) passed by the European Parliament becomes effective on May 26, 2024.
However, compliance with the MDR could be ensured and exports could continue unhindered if the government moves to assist the exporters in having the required technicalities and the registration process done diligently.
In its latest report, titled “Medical Device Regulation in the European Union - Costs and Procedures: How the Government can Support Exporters,” the Trade Development Authority of Pakistan (TDAP) has highlighted that manufacturers of the surgical instruments would face significant challenges due to the high cost and technicality of documents that are required for registration with the European Union’s MDR. The report said that exports of surgical goods to the European markets will be affected if manufacturers were not registered under the new scheme.
The report highlighted that transition from Medical Device Directives (MDD) to MDR will raise the cost of Pakistani manufacturers and distributors and may eliminate the market share of the small and medium-sized manufacturers and distributors in the European market because the amount they earn through export is less than the cost associated with the regulation.
The TDAP report recommends that subsidies should be provided to small and medium-sized manufacturers in the registration process because they have the potential to grow. “Pakistan must explore new avenues for exporting surgical goods, including African and Middle Eastern markets,” the report underscored.
It pointed out that the total number of registered surgical exporters in Pakistan was 1,715, of which 59 were large firms, 625 medium, and 1,031 small-scale exporters. It added that large-scale firms exported around 45% of surgical goods.
The report shows that Pakistan’s surgical exports to European Union grew 14% to $120 million in 2021, up from $105 million in 2020. Germany bought the most surgical goods from Pakistan. Exports to Germany, France, Italy, the Netherlands, and Belgium stood at $54 million, $12.5 million, $7.4 million, $6.5 million, and $4.5 million in 2021, respectively.
Frigz International, Surgicrafts, and QSA Surgical are the top exporters of surgical items to the European market and are in the implementation process of the quality management system in order to be registered under the MDR, the TDAP report said.
The report of the national trade promotion body said that Pakistan specialised in conventional surgical products, but the demand for these products in developed countries had decreased by almost 45% in the last five years due to the rise of Artificial Intelligence-enabled and electronic products with high precision.
The report added that due to lack of research and development, surgical products will lose market share not only in Europe but also globally.
Data from Pakistan Bureau of Statistics shows that the export of surgical goods and medical instruments during the first four months of the current fiscal year recorded a growth of 9.1% to $147.335 million, up from $135.039 million during the same period of the previous fiscal year.
On a year-over-year basis, the export of surgical goods grew 6.78% to $39.392 million in October 2022 against $36.892 million in October 2021.