Service for Declaration of Adequate Conditions for Manufacturing Medical Devices

Legal Basis

– Decree No. 98/2021/ND-CP issued on November 8, 2021: Management of medical devices.

– Decree No. 07/2023/ND-CP issued on March 3, 2023: Amendments and supplements to some articles of Decree No. 98/2021/ND-CP dated November 8, 2021, of the Government on the management of medical devices.

– Circular No. 19/2021/TT-BYT issued on November 16, 2021: Regulation of document templates, reports on the implementation of Decree No. 98/2021/ND-CP dated November 8, 2021, of the Government on the management of medical devices.

– Circular 05/2022/TT-BYT  issued on August 1, 2022: Detailing the implementation of some provisions of Decree No. 98/2021/ND-CP dated November 8, 2021, of the Government on the management of medical devices.

Quality Management Requirements for Medical Device Manufacturing Facilities

1. ISO 13485 Certificate – quality management system standard.

2. Facilities manufacturing medical devices containing narcotics and precursors, in addition to meeting ISO 13485 standards, must meet the following requirements:

a) Have a monitoring system for the export, import, inventory, and use of raw materials (narcotics and precursors), export, import, inventory of medical devices, and raw materials containing narcotics and precursors.
b) Medical devices and raw materials containing narcotics and precursors must be stored in a separate location in the warehouse or in a separate warehouse, ensuring safety.

Documentation for Declaring Adequate Conditions for Medical Device Manufacturing

1. Declaration of Adequate Conditions for Medical Device Manufacturing.

2. ISO 13485 Certificate – issued by the conformity assessment organization as required by law.

3. Documents proving compliance with conditions for facilities manufacturing medical devices containing narcotics and precursors.

Requirements for Documentation Declaring Adequate Conditions for Medical Device Manufacturing

The medical device dossier must be prepared in one set, including:

a) Documents in the dossier must be clearly printed, arranged in the prescribed order; there should be separators between sections, cover pages, and a document index.
b) Non-Vietnamese documents must be translated into Vietnamese and notarized according to legal regulations.

Requirements for Some Documents in the Declaration of Adequate Conditions for Manufacturing Medical Devices

a) Original or authenticated copy or copy with confirmation from the proposing facility for declaring adequate conditions for production concerning the ISO 13485 Certificate.
b) Original with confirmation from the proposing facility for declaring adequate conditions for production regarding documents proving compliance with conditions for facilities manufacturing medical devices containing narcotics and precursors.

Procedure for the Declaration of Medical Device Production Conditions

1. Before implementing the production of Medical Device, the medical device manufacturing facility must submit a declaration dossier to the Health Department located at the production site (the determination of the production site is based on the location specified in the ISO 13485 certificate). If there are multiple production sites in different provinces, a declaration of the production conditions for each province must be made.

2. Upon receiving the dossier (including the confirmation of fee payment), the Health Department at the location of the medical device manufacturing facility will publicly post the information and declaration dossier of the production conditions for the medical device on the electronic information portal for the management of medical devices.

3. In the event of any changes during the production process, the Manufacturing Facility must create a written notification of the changes along with relevant documents regarding the modified information. Simultaneously, these documents should be updated in the publicly disclosed declaration dossier on the electronic information portal for the management of Medical Devices within a period of 3 working days (from the date of the information change in the declaration dossier of the production conditions for Medical Devices)

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