What is a Class A medical device? What are the classification rules for medical devices?
What is a Class A medical device?
Article 4 of Decree 98/2021/ND-CP of Vietnam stipulates the classes of medical devices:
"Article 4. Classes of medical devices
Medical devices shall be classified into the following 4 classes according to their levels of potential risks related to their designs and manufacture:
1. Class A: Low risk.
2. Class B: Low-moderate risk.
3. Class C: Moderate-high risk.
4. Class D: High risk."
Thus, there are 4 types of medical devices, of which class A medical device has a low risk.
What is a Class A medical device? What are the classification rules for medical devices? (Image from the Internet)
What are the classification rules for medical devices?
To classify types of medical devices based on Article 5 of Decree 98/2021/ND-CP of Vietnam as follows:
“Article 5. Classification rules for medical devices
1. The classification of medical devices must be carried out in accordance with risk classification rules.
2. In the event that a medical device only has one intended purpose which is assigned into two or more risk levels, that medical device shall be assigned into the class representing the highest risk level.
3. In the event that a medical device has multiple intended purposes and each of which represents various risk levels, that medical device shall be assigned into the class representing the highest risk level.
4. In the event that a medical device is designed to be used in combination with another medical device, each of the medical devices shall be classified separately.
IVD medical devices that are equipment or systems used in testing process and reagents, titrants, calibrators or control materials may be assigned into various risk levels but assigned into the class representing the highest level of risks posed by the final purpose of that medical device as a whole. IVD medical devices that are other products used in or supporting testing process may be separately assigned into risk levels.
5. The Minister of Health shall provide detailed guidelines on classification of medical devices in accordance with ASEAN’s treaties on classification of medical devices to which Vietnam is a signatory.
6. The classification of medical devices must be carried out by the classification body whose name is specified in the declaration of applied standards or certificate of registration of medical device.”
Thus, basically, the classification of medical devices will be based on the level of risk of such equipment. In specific cases, the above regulations will be followed.
How to handle Class A medical devices using the record of classification results which is found fraudulent?
Pursuant to Point b, Clause 1, Article 6 of Decree No. 98/2021/ND-CP of Vietnam, in case medical devices of class A or other classes use the record of classification results which is found fraudulent, the classification results are cancelled.
And in Article 7 of Decree 98/2021/ND-CP of Vietnam stipulating the handling of medical devices whose classification results are cancelled as follows:
“Article 7. Handling of medical devices whose classification results are cancelled
1. In case a medical device whose classification result is cancelled has not been granted the registration number:
a) The applicant for registration number shall send a written request to the receiving authority to suspend procedures for issuance of registration number.
b) After receiving the written request mentioned in Point a of this Clause or the decision to cancel classification result, the receiving authority shall refuse to issue the registration number.
2. In case a medical device whose classification result is cancelled has been granted the registration number but has not been granted customs clearance:
a) The registration number holder shall stop following procedures for customs clearance, request the checkpoint customs authority to suspend procedures for customs clearance, and request the registration number issuer to revoke the issued registration number.
b) After receiving the written request from the registration number holder or the decision to cancel classification result, the customs authority shall suspend procedures for customs clearance, and the registration number issuer shall follow procedures to revoke the issued registration number.
3. In case a medical device whose classification result is cancelled has been granted the registration number and customs clearance but has not been purchased:
a) The registration number holder shall:
- Stop placing on the market and recall the medical device granted the registration number using the classification result that has been cancelled;
- Send a report to the customs authority that granted customs clearance in which the quantity of medical device granted customs clearance must be specified, and do not follow procedures for import of the following shipments until the relevant medical device is granted a new registration number using the correct classification result;
- Send a report to the registration number issuer specifying the quantity of medical device granted customs clearance and the sale contracts (if any);
- Reapply for the registration number.
b) After receiving the registration number holder’s written request or the decision to cancel classification result:
- The customs authority shall refuse to grant customs clearance;
- The registration number issuer shall revoke the issued registration number.
4. If the medical device has been sold to health facilities:
a) The registration number holder shall:
- Send a report to the registration number issuer specifying the quantity of medical device sold to health facilities;
- Send written notices to health facilities that purchased the medical device.
b) If the medical device granted the registration number using incorrect classification result does not pose threats to patients’ heath, health facilities may keep using the medical device and the registration number holder shall supplement the documents about registration of the medical device after a new registration number is granted.
c) If the medical device granted the registration number using incorrect classification result is found to pose threats to patients’ heath, health facilities shall stop using the medical device and the registration number holder shall implement necessary measures for ensuring normal operation of such health facilities.”
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