Vietnam: What is an active medical device? What are the classifications for invasive and non-invasive medical devices?
What is an active medical device according to Vietnamese regulations?
Pursuant to the provisions of Part I, Section 1, Appendix I promulgated together with Circular 05/2022/TT-BYT on the interpretation of words, accordingly:
“In this rule, the following terms are construed as follows:
1. Active medical equipment means medical equipment operating on the principle of using and transforming electrical energy or other energy sources that are not sources of energy generated by the human body or physical ability.
Medical devices used to transfer energy, substances or other elements from the active medical device to the human body without causing major changes to these elements are not defined as active medical device.”
Accordingly, active medical equipment is medical equipment operating on the principle of using and transforming electrical energy or other energy sources that are not energy sources generated by the human body or the physical ability.
Classification rules for non-invasive medical devices in Vietnam?
Pursuant to the provisions of Part II, Section 1, Appendix I issued together with Circular 05/2022/TT-BYT stipulating the classification rules for non-invasive medical equipment:
“A. RULE PH n TYPE FOR MEDICAL DEVICES DO NOT IMPORT
Rule 1. Classification for medical devices in contact with damaged skin
1. All non-invasive medical devices that come into contact with skin wounds of category A if used as a mechanical barrier, with only the function of promoting or absorbing fluids for the purpose of initial wound healing.
2. Non-invasive medical devices used primarily with wounds that penetrate the dermis, including medical devices used primarily to control the environment of the wound of class B,
3. Non-invasive medical devices used primarily for wounds that penetrate the dermis and are only otherwise healed are in Class C.
Rule 2. Classification for non-invasive medical devices used for transmission or storage
All non-invasive medical devices intended for the infusion of or containing bodily fluids, tissues, liquids or gases with the ultimate purpose of infusion, ingestion or infusion are classified in Class A if: does not fall into the following cases:
1. Medical equipment that can be connected to active medical equipment of class B or higher of class B.
2. Medical devices used for blood transfusion, storage or infusion of other body fluids or preservation of organs, parts of organs or body tissues are of class B.
3. Blood bag of type C.
Rule 3. Classification for non-invasive medical devices with bio-chemical conversion function
Non-invasive medical devices used to change the chemical or biological composition of blood, body fluids, or other fluids for infusion are in Class C. Unless the treatment includes filtration, centrifugation or gas or heat exchange, in this case class B.
Rule 4, Classification for Other Non-Intrusive Medical Devices
All other non-invasive medical devices are in Class A.”
Accordingly, the classification rules for non-invasive medical devices include 4 rules as follows:
- Classification for medical devices in contact with damaged skin
- Classification for non-invasive medical devices used for transmission or storage
- Classification for non-invasive medical devices with the bio-chemical conversion function
- Classification for other non-invasive medical devices.
Vietnam: What is an active medical device? What are the classifications for invasive and non-invasive medical devices?
What are the classification rules for invasive medical devices in Vietnam?
Pursuant to the provisions of Part II, Section 1, Appendix I issued together with Circular 05/2022/TT-BYT stipulating the classification rules for invasive medical equipment:
“B. RULE PH n TYPE FOR IMPORTED MEDICAL DEVICES X M
Rule
5. Classification of non-surgical infiltration of medical devices through body holes
1. Medical devices that enter through the body's openings without surgery, must not be used to connect with active medical devices or only connect with medical devices of this type. A is in Class A if the medical devices are for temporary use. In the case of medical devices of this type intended to be used on the body surface, the eyeball or with the ability to be absorbed by the mucosa is of class B.
2. Medical devices that enter through the body's openings without surgery, must not be used to connect with active medical devices or only connect with medical devices of this type. A is in category B if the medical devices are intended for short-term use. Where this medical device is used in the body area from the oral cavity to the pharynx, from the cochlea to the tympanic membrane or in the nasal cavity, it is classified in class A.
3. Medical devices that enter through the body's openings without surgery, must not be used to connect with active medical devices or only connect with medical devices of this type. A is in category C if these medical devices are used for a long time. In the case of this medical device used in the body area from the oral cavity to the pharynx, from the cochlea to the eardrum or in the nasal cavity and is not able to be absorbed by the mucosa is classified as class B.
4. All body orifice invasive medical devices (except surgical entry) intended to be connected to an active medical device of class B or higher are classified in type B.
Rule 6. Classification of surgically invasive medical devices for temporary use
All surgically invasive medical devices for temporary use are classified as Class B, if not in the following cases:
1. Medical devices are reusable surgical instruments of class A.
2. Medical devices used to provide energy in the form of ionizing radiation are of class C.
3. Medical devices intended to produce biological effects or to be completely or largely absorbed are in Class C.
4. Medical devices intended to deliver medicinal products into the body by means of a delivery system that are potentially hazardous when applied are classified in Class C.
5. Medical devices specifically designated for use with direct central nervous system contact are in Class D.
6. Medical devices specifically indicated for the diagnosis, monitoring or repair of defects of the heart or of the central circulatory system by direct contact with these parts of the body are in Class D .
Rule 7. Classification of surgically invasive medical devices for short-term use
All invasive surgical medical devices for short-term use are classified as Class B unless they fall into the following categories:
1. Medical devices used to deliver drug products are in category C.
2. Medical devices used to undergo chemical transformations in the human body (except in the case of devices placed in the teeth) are in class C.
3. Medical devices used to provide energy in the form of ionizing radiation are of class C.
4. Medical devices used to produce a biological effect that are either completely or largely absorbed are in Class D.
5, Medical devices that come into direct contact with the central nervous system are classified as D.
6. Medical devices specifically indicated for the diagnosis, monitoring or repair of a defect of the heart or of the central circulatory system by direct contact with these parts of the body belong to type D.
Rule 8. Classification of surgically invasive medical devices for long-term use and implantable medical devices
All surgically invasive medical devices for long-term use and implantable medical devices are classified as Class C if they do not fall into the following categories:
1, Medical devices used for placing in teeth are of class B,
2. Medical devices when used in direct contact with the heart, central circulatory system or central nervous system are classified as D.
3. Medical devices used to support or sustain life are classified as D.
4. Medical equipment that is also active medical equipment of class D,
5. Medical devices used that have a biological effect or are completely or largely absorbed are of Class D,
6. Medical devices used to deliver drug products of category D,
7. When used, medical devices must undergo chemical transformations in the human body (except in the case of devices placed in the teeth) of class D.
8. Medical devices covered by this rule used for breast implants are in Class D.”
Thus, the classification rules for non-invasive medical devices include four rules as follows:
- Classification for medical devices in contact with damaged skin;
- Classification for non-invasive medical devices used for transmission or storage;
- Classification for non-invasive medical devices with bio-chemical conversion function;
- Classification for other non-invasive medical devices.
LawNet
1 view
