Circular No. 39/2016/TT-BYT details the classification of medical devices into four types A, B, C, and D based on specific rules set out in Appendices I and II. This document applies to organizations qualified to classify medical devices.
적용 범위
Organizations qualified to classify medical devices
핵심 사항
- Medical devices are classified into four types A, B, C, and D according to the rules specified in Appendix I (Article 1.1).
- The classification of medical devices is applied to one or a group of categories based on registration number grouping rules set out in Appendix II (Article 1.2).
- Organizations implementing the classification of medical devices must comply with the rules stipulated in this Circular.
- Organizations and individuals encountering difficulties during implementation may report to the Ministry of Health for support.
- This Circular takes effect from December 15, 2016 (Article 2.1).
🌐 이 문서의 사회적 영향
- Positive impact: Ensures that the classification of medical devices is carried out uniformly and transparently.
- Negative impact: Organizations may encounter difficulties in applying new rules.
❓ 자주 묻는 질문
To whom does this Circular apply?
It applies to organizations qualified to classify medical devices.
Medical devices are classified into how many types?
Four types A, B, C, and D.
Where are the classification rules specified in this Circular?
In Appendices I and II of the Circular.
If difficulties arise during implementation, what can an organization do?
Report to the Ministry of Health (Department of Medical Equipment and Healthcare Infrastructure) for support.
전문
CIRCULAR
DETAILING THE CLASSIFICATION OF MEDICAL DEVICES
Pursuant to Decreedisorderly code or typo; no translatable content provided. No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to Clause 5, Article 5 of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical device management;
At the proposal of the Director of the Medical Equipment and Health Facilities Department,
The Minister of Health issues this Circular detailing the classification of medical devices.
Article 1. Classification of medical devices
1. Medical devices are classified into four categories A, B, C, D according to the rules specified in Appendix I attached hereto.
2. Medical devices are classified into four categories A, B, C, D for one or a group of types of medical devices according to the registration number circulation grouping rules set forth in Appendix II attached hereto.
Article 2. Effectiveness and responsibility for implementation
1. This Circular takes effect from December 15, 2016.
2. Organizations meeting the conditions to carry out medical device classification must apply the rules stipulated in Article 1 of this Circular when conducting such classifications. Any difficulties or issues encountered during implementation should be reported to the Ministry of Health (Medical Equipment and Health Facilities Department) for consideration and resolution.
During the course of implementation, any difficulties or issues should be reported to the Ministry of Health (Medical Equipment and Health Facilities Department) for consideration and resolution./.
VICE MINISTER
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