Procedures for declaration of product specification for medical device-class a not covered by warranty

Because medical devices have their subgroups with different requirements, in which there are some groups of medical devices that apply the conditions of the warranty regime and some other ones do not apply this condition. For the group that applies the warranty conditions, which must be met in terms of capacity, documents proving the equipment warranty capacity of the medical device owner are mandatory conditions. On the other hand, the group that does not apply to this condition will be more convenient, the application will be simpler for circulation registration dossiers as well as the process of circulation and distribution of products on the market. Therefore, to help our Clients refer to information clearly, transparently and limit confusion, in this article, we focus on providing regulations and legal frameworks for the procedures for announcing standards applicable to Medical Device – Class A without warranty (“MD-A_WW”).

It can be seen that in order to be circulated MD-A_WW in the market, according to Article 22 of Decree 98¹, this device must meet the conditions such as: Have a registration number, have a label with full information in accordance with the current provisions of the law on goods labels, Have a user manual of the device in Vietnamese. In particular, for MD-A_WW, the circulation license is “Product Specification Number”².

There are some key points and steps to be taken in accordance with the current law when announcing the standards applicable to MD-A_WW.

1. Regarding the conditions for publishing applicable standards

MD-A_WW is only allowed to carry out the procedures for announcing applicable standards when: (i) The device is manufactured at a manufacturing facility that has announced the eligibility for manufacturing for domestically manufactured medical devices or is manufactured at a manufacturing facility that has been granted a certificate of compliance with ISO 13485 quality management standards and is circulated in any country which country in the world for imported medical equipment; and (ii) such device must conform to national technical regulations or standards declared by the manufacturer to be applicable³.

Note: If the medical device has been announced as an applicable standard, however, for any reason, the announced number is revoked by a competent state agency, in this case, within 12 months from the date of revocation of the published number, the organization/individual will not be allowed to receive the dossier of announcement of the applicable standard⁴.

2. Requirements for organizations declaring applied standards

Organizations that declare applied standards or apply for registration number for medical devices include: (i) Vietnamese enterprises, cooperatives or household businesses that are product owners; or (ii) Vietnamese enterprises, cooperatives or household businesses that are authorized by product owners; or (iii) Permanent representative offices in Vietnam of foreign traders that are product owners or authorized by product owners.

3. Regarding the application for declaration of applied standards⁵

An application for declaration of applied standards for medical device consists of:

(i) The declaration of applied standards. This document must be submitted in original document;

(ii) Valid Certificate of conformity with quality control standards at the time of submitting the notification dossier;

This document must be submitted in original copy or certified true copy or copy bearing certification of the declarant. If the Certificate of conformity with quality control standards is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.

(iii) The unexpired letter of authorization given by the product owner to the organization that applies for declarant of applied standards. For this document: If it is a domestically manufactured medical device, it is required to submit its original copy or certified true copy; If it is an imported medical device, either the document bearing consular legalization or the certified true copy thereof is accepted.

(iv) A synopsis of technical description of the medical device in Vietnamese, accompanied by technical documents describing functions and specifications of the medical device issued by the product owner.

Note: With regard to in-vitro reagents, calibrators and control materials, the synopsis of technical description in Vietnamese must be accompanied by documents on materials and safety of the product, manufacturing process, pre-clinical and clinical trial reports including stability report.

(v) Certificate of conformity or product specification provided by the product owner. This document must be submitted by original copy or copy bearing certification of the declarant. If the product specification is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.

(vi) With regard to domestically manufactured medical devices, the assessment record of chemical, physical and microbiological indicators and other indicators provided by a qualified conformity assessment body in accordance with regulations of law on conformity assessment is required; if it is an IVD medical device, certificate of quality assessment issued by a competent authority of Vietnam is required. The assessment result must be conformable with the standards declared by the product owner. This document is required to submit its original copy or certified true copy;

(vii) User manual of the medical device;

Note: Vietnamese copy bearing certification of the declarant, accompanied by English version issued by the product owner, in case of imported medical devices. If the user manual is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.

(viii) Sample of the label for the medical device sold in Vietnam;

Note: The sample label bearing certification of the declarant. The sample label must meet requirements laid down in regulations of law on labeling of goods.

(ĩ) An unexpired CFS for imported medical devices;

Either the document bearing consular legalization or the certified true copy thereof is accepted. If the CFS is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.

4. Procedures for declaration of applied standards⁶

Before placing the device on the market, the declarant must submit an application for declaration to the Department of Health of province where it is headquartered;
Submitting the application and Paying the government fee with an amount of VND 1,000,000/each device.
After receiving the application (including application fee receipt as prescribed by the Ministry of Finance), the Department of Health of province where the declarant of the medical device is headquartered shall publish the number of declaration of applied standards for device on the Portal on management of medical devices and applications for declaration of applied standards;

Note: There is no clear regulation on required timeline of this step. However, as Apolat Legal’s experience in fact, this step shall take around 07 – 10 working days after submitting all valid documents.

Above are some of the information that Apolat Legal would like to provide to Clients for your reference.

^{(1) Decree No. 98/2021/ND-CP dated November 8, 2021, of the Government on management of medical devices.}

^{(2) Point a Clause 1 Article No. 21 Decree No. 98/2021/ND-CP.}

^{(3) Clause 1 Article No. 23 Decree No. 98/2021/ND-CP.}

^{(4) Clause 3 Article No. 23 Decree No. 98/2021/ND-CP.}

^{(5) Article No. 27, 28 Decree No. 98/2021/ND-CP.}

^{(6) Article No. 28 Decree No. 98/2021/ND-CP.}

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Disclaimers:

This article is for general information purposes only and is not intended to provide any legal advice for any particular case. The legal provisions referenced in the content are in effect at the time of publication but may have expired at the time you read the content. We therefore advise that you always consult a professional consultant before applying any content.

For issues related to the content or intellectual property rights of the article, please email cs@apolatlegal.vn.

Apolat Legal is a law firm in Vietnam with experience and capacity to provide consulting services related to Business and Investment and contact our team of lawyers in Vietnam via email info@apolatlegal.com.

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