The Government on November 8 issued Decree 98 on management of medical equipment, which is expected to lead significant changes in the management of medical equipment in the country.
The Government on November 8 issued Decree 98 on management of medical equipment, which is expected to lead significant changes in the management of medical equipment in the country.
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Accordingly, from the beginning of 2022, class-B medical equipment, which is currently regarded as being subject to low or moderate risks, will have their applicable standards declared by their importers or traders instead of being considered and licensed for circulation by competent authorities as at present.
For class-C and class-D medical equipment, currently regarded as being subject to moderate or high risks, circulation numbers granted by developed countries with strict quality control and circulation licensing processes, such as the US, Japan, Canada, Australia, may be recognized in the country.
In other words, if medical equipment has been licensed for circulation by one of those countries, the Ministry of Health will accept its circulation in the country without checking their technical documents. As a result, the time for grant of circulation licenses for them may be reduced to ten working days from current 60 days.
The new Decree delegates power to specialized units to carry out the checking of technical documents and quality control, and the Ministry of Health, based on checking results, will issue licenses after examining administrative dossiers.
It removes conditions for classifying technicians and organizations and simplifying administrative procedures for declaration of eligibility for medical equipment classification. Instead, medical equipment registration number grantees will be responsible for the medical equipment classification results.
In addition, enterprises will no longer have to carry out procedures for licensing, modification and certification of advertisements for their medical equipment, and replaces such procedures by publishing on the Portal for medical equipment management necessary information about advertisements to be made after they are publicized.
Circulation numbers of medical equipment will be valid for an indefinite term, instead of five years as at present. Enterprises will not be required to carry out procedures for renewal of such numbers as before. However, they will be responsible for updating their records upon any change in the circulation of medical equipment.
Worthy of note, the new regulation sets requirements for declaration of prices of medical equipment and biologicals for testing.
Specifically, such price declarations must include import prices of imported medical equipment or production costs of domestically produced medical equipment, management, training and warranty costs, profits expected to be earned, and final selling prices.
Circulation number grantees or distributors authorized by owners of medical equipment may make price declarations of medical equipment. Other distributors may not sell medical equipment at prices higher than those declared by owners and are required to announce their selling prices.
Under the new Decree, state management agencies may request enterprises to explain medical equipment cost components when necessary.
(Source:VLLF)
