PRC Ministry of Health Issues Measures on Centralized Procurement of High Value Medical Devices
On December 17, 2012, the Ministry of Health (“MOH”) issued a new regulation that subjects certain high-value medical devices to a centralized procurement regime.
The Measures on Centralized Procurement of High Value Medical Consumables (“Measures”) defines “high value medical consumables” as those massively-used, relatively high-priced products that are used directly on the human body and require high safety standards. Vascular and non-vascular invasive devices, orthopedic implants, neurosurgery and electro-neurophysiology devices, pacemakers, extracorporeal circulation and blood purification systems, ophthalmology and stomatology devices are included. A detailed product catalogue is being developed by provincial health authorities.
Pursuant to these Measures, all non-profit medical institutions in China that are at or above the county level must purchase such devices through a centralized procurement process organized by provincial public health authorities. Private medical institutions may participate in such procurement on a voluntary basis. Manufacturers are required to participate in the procurement directly; exclusive distributors of foreign products or distributors owned by the manufacturers may participate in the procurement as if they were manufacturers. Products going through the procurement shall be directly delivered by the manufacturers or by its contracted distributors, and the logistics charges should be covered in the bidding prices.
There are a number of manufacturer qualification requirements listed. Penalties are also set forth for various violations including commercial bribery or failure to supply products, all of which could disqualify a manufacturer from participating for 2 years.
Sidley China Life Sciences Practice
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