Medical equipment enterprises face difficulties with requirements for certification of origin
Many businesses in the European Medical Equipment and Diagnostic Association have reported difficulties in participating in bidding to supply equipment for hospitals. Accordingly, some hospitals require the winning bidder to submit a certificate of origin (CO) for each imported shipment.
According to businesses, the hospital's goal of preventing counterfeit goods and counterfeit goods to ensure transparency of origin is completely legitimate. However, according to Decree 98/2021, the medical equipment quality management dossier only requires valid CO for the product, not mandatory for each shipment. The addition of CO to each batch creates a large burden, causing delays in delivery.
A representative of a business said: Most of the equipment is imported from the US and Europe. To get CO for a shipment from the US, it takes 2 - 2.5 months, costs 100 - 300 USD; for Germany, it takes at least 1 month. Foreign manufacturers even refuse to issue CO for small batches. This makes it difficult for businesses to meet the schedule, even though the goods have been cleared by customs and have valid documents".
The enterprise recommends that the Ho Chi Minh City Department of Health accept the general CO of the product or the document committing the goods to the correct bid, instead of the CO for each batch. If necessary, the hospital can visit the warehouse or request an import dossier for verification. This approach is both transparent and helps reduce administrative procedures, ensuring the progress of equipment supply for patients.
A representative of the Ho Chi Minh City Department of Health said that according to Article 33 of Decree 98/2021, when having a circulation registration number or announcing a standard, businesses must establish a management system to trace the origin and store records. The quality management records include a license for circulation, distribution, incident and goods traceability. The Department acknowledges Ros Dainotic's opinions and will work with relevant units to unify the implementation of legal regulations, while reducing difficulties for businesses.
Cosmetic businesses face difficulties with procedures and regulations for product announcement
After merging administrative boundaries, many businesses reported that product labels must be used at the same address as the new and old, causing confusion in the circulation process.
The Department of Drug Administration, Ho Chi Minh City Department of Health said that for changes in administrative boundaries, current regulations apply according to Resolution 76 and Resolution 190 of the National Assembly in 2025. Accordingly, documents issued by competent authorities before arranging administrative boundaries are not required to be changed. Enterprises only need to apply for a new license when their documents expire according to the new boundary.
Regarding the announcement of cosmetic features, the Drug Administration Department cited Circular 06/2011, which defines cosmetics as purely for cleaning, beauty, fragrance, and protection of the body. If the enterprise announces a product to help moisturize and limit dry skin caused by eczema, the Department of Health will still approve. However, if the product is advertised as being able to treat eczema, a specific disease, it will be rejected, because this is beyond the scope of cosmetics.
Thus, the Department of Health affirmed that it will continue to review and listen to businesses' opinions to both ensure compliance with the law and remove difficulties for production and business activities.
