Circular No. 46/2017/TT-BYT details certain provisions of the Government's Decree No. 36/2016/NĐ-CP on medical equipment management, including cases exempted from providing summaries of clinical trial data and certificates of testing, lists of medical equipment sold as ordinary goods, and guidelines for presenting technical description documents.
适用范围
Medical equipment manufacturing, import, and distribution facilities; state management agencies in health
要点
- Medical equipment of Class C, D that invades the human body upon importation or has been circulating in countries listed in Appendix II does not need to provide a summary of clinical trial data (Article 2).
- In vitro diagnostic medical equipment of Class C, D that has been circulating and holds a free circulation certificate from countries or organizations listed in Appendix II does not need to provide a certificate of testing when registering for circulation (Article 3).
- Lists of medical equipment of Class B, C, D sold as ordinary goods do not require publication of sufficient conditions for sale (Article 4).
- The technical description document of domestically produced medical equipment must fully specify international/country standards and regulations on basic standards according to Circular No. 21/2007/TT-BKHCN (Article 5).
- Vietnamese phrases on the power of attorney form must be translated into English according to the guidance provided in Appendix IV (Article 6).
🌐 本文件的社会影响
- Reducing costs and time for businesses when they do not have to provide a summary of clinical trial data or a certificate of testing.
- Increasing transparency in the sale of medical equipment within the specified list.
- Improving the quality of technical description documents and English-language powers of attorney, facilitating international transactions.
❓ 常见问题
Which medical equipment does not need to provide a summary of clinical trial data?
Medical equipment of Class C, D that invades the human body upon importation or has been circulating in countries listed in Appendix II.
Which in vitro diagnostic medical equipment does not need a certificate of testing?
In vitro diagnostic medical equipment of Class C, D that has been circulating and holds a free circulation certificate from countries or organizations listed in Appendix II.
Which list of medical equipment can be sold as ordinary goods?
Medical equipment of Class B, C, D as specified in Appendix III.
What requirements must the basic standards used for producing medical equipment meet?
They must comply with the provisions of Circular No. 21/2007/TT-BKHCN issued by the Ministry of Science and Technology.
How should Vietnamese phrases on the power of attorney form be presented?
They must be translated into English according to the guidance provided in Appendix IV.
全文
CIRCULAR
Providing detailed implementation of certain provisions of Decree No. 36/2016/NĐ-CP dated May 15,
2016 of the Government on medical equipment management
Pursuant to Decree No. 75/2017/NĐ-CP dated October 27, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health; the 6 year of 2017 Cof the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical device management;
At the proposal of the Director of Medical Equipment and Construction Department,
The Minister of Health issues this Circular providing detailed implementation of certain provisions of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical equipment management.
Article 1. Scope of Regulation
This Circular stipulates on:
1. Cases exempted from providing a summary of clinical trial data and clinical trial results when registering for circulation as specified in point k Clause 1 Article 26 of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical equipment management (hereinafter referred to as Decree No. 36/2016/NĐ-CP).
2. Cases exempted from providing a certificate of testing for in vitro diagnostic medical devices when registering for circulation as specified in point l Clause 1 Article 26 of Decree No. 36/2016/NĐ-CP.
3. List of medical equipment classified as types B, C, D that can be bought and sold like ordinary goods as specified in Clause 1 Article 39 of Decree No. 36/2016/NĐ-CP.
4. Guidelines for presenting technical summary documentation for domestically produced medical equipment according to Model 01 Appendix VIII issued together with Decree No. 36/2016/NĐ-CP.
5. Guidelines for presenting Vietnamese phrases translated into English in the power of attorney form as specified in Appendix VI issued together with Decree No. 36/2016/NĐ-CP.
Article 2. Cases exempted from providing a summary of clinical trial data and clinical trial results when registering for circulation of medical equipment
1. Imported medical equipment classified as types C, D that intrude into the human body as specified in Appendix I attached hereto.
2. Medical equipment classified as types C, D that have been circulating and granted a free circulation certificate by one of the countries or organizations listed in Appendix II attached hereto.
Article 3. Cases exempted from providing a certificate of testing for in vitro diagnostic medical devices when registering for circulation
In vitro diagnostic medical devices classified as types C, D that have been circulating and granted a free circulation certificate by one of the countries or organizations listed in Appendix II attached hereto.
Article 4. List of medical equipment classified as types B, C, D that can be bought and sold like ordinary goods
1. List of medical equipment classified as types B, C, D that can be bought and sold like ordinary goods as specified in Appendix III attached hereto.
2. Trading entities dealing with medical equipment listed in the list of medical equipment classified as types B, C, D that can be bought and sold like ordinary goods are not required to declare their qualification for trading in medical equipment.
Article 5. Guidelines for presenting technical summary documentation
The description of the content stipulated in item 1.1 of the Technical Summary Documentation for domestically produced medical equipment according to Model 01 Appendix VIII issued together with Decree No. 36/2016/NĐ-CP shall be carried out as follows:
1. Describe the operating principle and features, technical specifications of the equipment, fully stating the names of international standards, national standards, national technical regulations, enterprise standards used for production and serving as the basis for quality inspection, effectiveness, and safety assessment of medical equipment.
2. For cases where enterprise standards are used for production and serving as the basis for quality inspection, effectiveness, and safety assessment of medical equipment, the enterprise standards must comply with the provisions of Circular No. 21/2007/TT-BKHCN dated September 28, 2007 of the Minister of Science and Technology guiding the construction and application of standards.
3. If international standards are used, the source for reference must be clearly stated.
Article 6. Guidelines for presenting Vietnamese phrases translated into English in the power of attorney form
The presentation of Vietnamese phrases translated into English in the power of attorney form prescribed in Appendix VI issued together with Decree No. 36/2016/NĐ-CP shall be carried out in accordance with the provisions set forth in Appendix IV attached to this Circular.
Article 7. Effective Date
This Circular takes effect from February 1, 2018.
Article 8. Transitional Provisions
Technical documentation for medical devices and English-language power of attorney letters in the dossier for declaring applicable standards or registering for circulation that were signed before this Circular takes effect shall continue to be applied and do not need to be completed again in accordance with this Circular.
Article 9. Cross-References
In cases where the referenced documents in this document are replaced or amended, implementation shall be in accordance with the replacement or amended document.
Article 10. Implementation Organization
The Head of the Ministry's Office, the Inspector General of the Ministry, Department Heads, Bureau Chiefs, General Directors under the Ministry of Health, Provincial Health Service Directors of centrally governed cities and relevant agencies, organizations, and individuals are responsible for implementing this Circular.
In the course of implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are requested to promptly report to the Ministry of Health for consideration and resolution./.
DEPUTY MINISTER
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