Recalling 190 medical device declarations that violated regulations

The Hanoi Department of Health has just issued a decision requesting the recall of 190 standard announcements applicable to products classified as type A and B medical devices.

According to the decision, the reason for the recall is that the recalled products "do not fit the definition of medical devices", and their intended use does not satisfy the criteria of a medical device.

In addition, the units were also found to have carried out declaration procedures incorrectly and violated medical equipment management procedures.

Specifically, the list of recalled products mainly includes saline solution products, medical alcohol, nose and throat sprays, joint sprays, blood glucose meters, HIV test kits, flu tests, pain relief gels...

Many companies had their standards revoked for up to 20 products, for example, Bao Sam Pharmaceutical Joint Stock Company, including throat sprays, mouthwashes, nasal sprays, ear sprays, etc.

Phuc Cuong Oriental Medicine Company Limited and Elaphe Pharmaceutical Joint Stock Company both have 8 products whose registration numbers have been revoked, including many types of nose and throat sprays, joint sprays, ear drops, eye drops, multi-purpose saline solutions, 90-degree medical alcohol, etc.

V&S Pharmaceutical Company Limited Vietnam has 7 numbers recalled, Hanoi Pharmaceutical Joint Stock Company has 6 numbers including mouthwash, gargle, propolis spray.

Hanoi Pharmaceutical and Cosmetic Technology Joint Stock Company, Ha Anh Medical Equipment and Materials Company Limited, Hungary and Vietnam Joint Venture Company Limited, and Phu Minh Khang Pharmaceutical and Medical Equipment Company Limited all had their 5 numbers revoked.

Among them, the products of Ha Anh Medical Equipment and Materials Company Limited are spinal cement injection kits, surgical kits, various types of spinal puncture needles, multi-function drilling systems, and those of the Hungarian-Vietnamese Joint Venture Company Limited are pain relief sprays, Xuan Hong feminine hygiene solutions...

HAMO - PHAR Company Limited, NCK FARMACY High-Tech Agricultural Chemical Company Limited (Thanh Xuan, Hanoi), Binh Minh Pharmaceutical Company Limited, ODOGROUP International Pharmaceutical and Cosmetic Trading Joint Stock Company, EU Vietnam Import-Export Joint Stock Company all had their 4 numbers revoked.

Ngan Ha Pharmaceutical Investment Company Limited (Thanh Tri, Hanoi), Thanh Phat Pharmaceutical Company have 3 numbers revoked.

Some businesses specializing in distributing medical equipment are also on the list such as Medstand Pharmaceutical Joint Stock Company, Sun For Life Company Limited, KYH Bio Tech Vietnam Company Limited, Healthcare HCT Joint Stock Company, Khoi Nguyen Medical Import-Export Company Limited, long-standing businesses such as TW8 Pharmaceutical Chemical Joint Stock Company, TW9 Pharmaceutical Chemical Joint Stock Company...

It is worth noting that the list also includes the name of the Vietnam Institute of Traditional Medicine, with 5 recalled products including gels, creams, sinus sprays, and nasal sprays.

This shows that not only commercial enterprises but also research units violate regulations when they arbitrarily announce products of incorrect nature.

A detailed list of 190 recalled products is available here. Consumers can look it up for more information and avoid purchasing these products.

WILLOW

Source: https://tuoitre.vn/thu-hoi-190-so-cong-bo-thiet-bi-y-te-vi-pham-20250702201706155.htm