On 08/11/2021, The Government promulgates Decree No. 98/2021/ND-CP (“Decree 98/2021“) on medical devices management. The Decree uniformly regulates this matter and abolishes all previous decrees on the management of medical devices, including Decree No.36/2016/ND-CP, Decree No.169/2018/ND-CP, Decree No.03/2020/ND-CP. This article focuses on some remarkable provisions of Decree 98 as follows:
1. Amendment in procedures for the issuance of the registration of circulation number of medical devices:
Decree No. 98/2021/ND-CP amends the procedures for the issuance of the registration of circulation number of medical devices as follows:
- For class B medical devices: Change from the procedures for considering and issuing the registration of circulation number of medical devices for enterprises to the procedures for self-publication of applied standards;
- For class C, D medical devices: Apply the mechanism for recognition of registration of circulation number of medical devices conducted by countries that have strict quality control and issuing registration of circulation number of medical devices such as the US, Australia, Canada, Japan, EU, UK, Switzerland, China, Korea. With respect to it, if the above-mentioned countries have issued such a medical device the registration of circulation number, the Ministry of Health will acknowledge this result. Enterprises can submit the development together with other papers as prescribed in Clause 3, Article 30 of Decree 98/2021, to apply for a registration registration of circulation number.
In addition, Decree 98/2021 shortens the time for issuance of a registration of circulation number to from 90 days to 30 days or 10 working days depending on each type of application for a registration of circular number. Besides, Decree 98/2021 amends the validity of the registration circular number of medical devices to be indefinite, instead of just 5 years as the current provision. The Owners of registration circular numbers are no longer be required to implement the renewal procedure, but they are responsible for updating the records where there is an adjustment during the period of registration of medical devices.
2. Elimination of medical device classification procedures:
Decree 98/2021 removes the conditions for classifying technicians, organizations and cutting out the administrative procedures for a declaration of eligibility for medical device classification. The classification of medical devices will be conducted by the Owner of the registration of circulation number and is responsible for the classification results. It is expected that this regulation will directly affect all businesses, medical classification organizations and enterprises that apply registration of medical devices.
3. Abolishment of the procedure for advertising medical devices
Decree 98/2021 also abolishes the procedures for new issuance, re-issuance, adjustment of advertising contents for medical devices and replaces such procedures by requiring the enterprise to publish on the electronic portal on the management of medical devices the expected contents and forms of advertising to be implemented after the publicity. In other words, businesses can advertise medical devices without being certified by the Ministry of Health for advertising content. However, enterprises shall be solely responsible for the published content and form of advertising.
4. Requirement for declaration of prices of medical devices and biologicals for testing:
Decree 98 states management methods for the price of medical devices such as:
- Declaring the price of medical devices before registration in Vietnam and update if there is any amendment to the declared medical devices;
- Posting the wholesale and retail prices of medical devices in Vietnam dong at the transaction place or the place of sale of medical devices of the business establishment; public noticing on paper or other forms;
- Publicizing the winning bid for medical devices of public medical facilities.
In particular, the parties are not allowed to purchase and sell medical devices without the declared price and shall not purchase or sell medical devices at the price that is higher than the price declared on the website of the Ministry of Health at the time of purchase and sale.
Specifically, the Owner of registration of circulation number shall fully declare the following information: name; types of medical devices; producing country; unit; import cost of imported medical devices or production cost of domestically produced medical devices; the maximum selling price of medical devices regarding its configuration, technical features, etc. This information must be posted on the electronic portal of the Ministry of Health before the registration. When the price of medical devices changes, the Owner of the registration of circulation number shall update the price accordingly. Distributors of the Owner of registration of circulation number are not required to declare prices, except for the distributor designated by the Owner of the registration of circulation number. However, the distributor is not allowed to sell at a price higher than the price declared by the designated distributor.
Thus, these regulations on price declaration are not only binding on the Owner of the registration of circulation number but also on the Owner of the registration of circulation number’s distributor.
For the purpose of ensuring strict management of medical devices prices, Decree 98/2021 expands the responsibility of price constituents of the Owners of registration of circulation numbers when there are requirements from the tax authorities or any other regulatory authorities.
It is assumed that the amended regulations on measures for medical devices price management will specifically identify the subjects who are responsible for the selling price of medical devices, and these subjects shall be transparent with all information regarding the price of medical devices; and publicize information regarding the selling price of the owners, of each distributor, agent, and the winning bid price of such devices at state-owned medical facilities for all organizations, individuals can access and refer.
The amendment and supplementation of regulations on price management of medical devices is considered a measure to tighten the management of this particular product. The published price is expected to be the basis for medical facilities, citizens and businesses to consult to decide to buy medical devices for medical examination and treatment, taking the price of medical devices to be equivalent to their real value, suitable for configuration, technical features, value in use, demand for use, especially during the covid-19 pandemic. Therefore, according to Mr. Nguyen Minh Tuan, Director of the Department of Medical Devices and Construction, it is expected that the published price, configuration, and model of medical equipment on the portal will be the basis for the market price to be adjusted.
Decree 98/2021 is expected to affect all businesses that carry out one of those activities: classifying medical devices; manufacturing, clinical research, registration, trading, exporting, importing, providing medical devices services, advertising medical devices and businesses doing the consulting services on import and export of medical devices.
Decree 98/2021 comes into effect from January 1st, 2022.