ABSTRACT

The classification of medical devices based on the risk level is being developed in Vietnam. It mainly follows the ASEAN Medical Device Directive (AMDD)/GHTF recommendation. 39.5  Role of Distributors or Local SubsidiariesThe importer is the person who applies and holds the license for the import of a medical device. They have the following roles under Circular 24/2011/TT-BYT: (i) effective communication with the manufacturer, distributor, user, and DMEC (ii) responsible for local labeling activity, if any (iii) responsible for maintenance and services (iv) notification and management of safety information to the user and the authority (v) annual report to the authority about business activityDetails can be found in Circular 24/2011/TT-BYT. 39.6  Product Registration or Conformity 

Assessment Route and Time RequiredThe Medical Device Administration Control System is basically divided into two parts: pre-market approval and exemption. The DMEC is the competent authority and also responsible for conformity assessment. Conformity assessment committee includes DMEC, Medical Service Department, and other experts working within the Ministry of Health. Pre-market approval is in the form of import license application. The medical device categories are subjects of pre-market approval, including high risk one (e.g., implants) and high-value ones (e.g., MRI, PET). Other medical devices (except new medical device) are exempted. The importer will work directly with the customs for

clearance without import license. The documents required for pre-market approval and exemption products are the same. Suggested license Routes/StepsThe importer collects necessary documents and submits them to the DMEC. Following are the documents required: (i) CFG/CFS or CE marked (ii) ISO 9001 or ISO 13485 (iii) Catalogue (iv) Letter of authorization (v) Executive summary in Vietnamese • The DMEC receives the document and carries out assessment

(deficiency document will be requested from the importer, if any). • The conformity assessment committee meeting will be held to approve the document. • The Ministry of Health issues the import license, which is valid for one year from the date of issue. The importer pays the fee and receives the license.According to the regulation, the timeline for evaluation is 15 working days. 39.6.1  Quality System Regulation Vietnam follows ISO 9001, ISO 13485:2003, and Vietnam’s standards (TCVN). It is voluntary to follow them. 39.6.2  Product Registration and Quality System 

There is no specific rule for a combination product. Such a product will follow either the medical device or the pharmaceutical regu-lation. 39.6.3  Registration FeeThe fee for the import license is about USD 10-150 / product family, depending on the value of the product.