Chapter II
CLASSIFICATION 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.
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.
Article 6. Cancellation of classification results
1. Classification results shall be cancelled in the following cases:
a) The incorrect classification result reduces the level of risk of the medical device;
b) The record of classification results is found fraudulent.
2. Procedures for cancellation:
a) Within 01 working day from the day on which a conclusion mentioned in Clause 1 of this Article is given, the Ministry of Health shall issue a decision to cancel classification result which request the classification body to implement remedial measures (if any) and remove the cancelled classification result from the Portal on management of medical devices.
The decision to cancel classification result shall be sent to the classification body, Provincial Departments of Health, General Department of Customs and border checkpoint customs authorities, and published on the Portal on management of medical devices.
b) After receiving the decision to cancel classification result, the classification body shall cancel all classification results specified in the decision and implement remedial measures against its violations (if any).
c) After receiving the decision to cancel classification result, the authority that has received the application for declaration of applied standards or application for registration number (hereinafter referred to as “application for registration number”) shall review the registration numbers issued, and follow procedures for revoking the registration numbers of medical devices that have been issued using classification results specified in the Ministry of Health’s decision to cancel classification results.
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.
Tìm kiếm
Nghị định 98/2021/NĐ-CP (Bản Word)
Nghị định 98/2021/NĐ-CP (Bản Pdf)