Chương III Nghị định 98/2021/NĐ-CP: Sản xuất trang thiết bị y tế

Chapter III

MANUFACTURE OF MEDICAL DEVICES

Article 8. Requirements for quality control by medical device manufacturer

1. The manufacturer’s quality control system must comply with ISO 13485.

2. A manufacturer of the medical device that contains narcotic substances and precursors shall, in addition to the requirements laid down in Clause 1 of this Article, also meet the following requirements:

a) It has a system for monitoring the dispatching, warehousing, inventory and use of narcotic substances and precursors, the medical devices and raw materials containing narcotic substances and precursors;

b) Medical devices and raw materials containing narcotic substances and precursors must be safely stored in a separate area or warehouse.

Article 9. Application for declaration of eligibility for manufacture of medical devices

An application for declaration of eligibility for manufacture of medical devices includes:

1. The declaration of eligibility for manufacture of medical devices.

2. Certificate of conformity with ISO 13485 quality control standards issued by the conformity assessment body in accordance with regulations of law.

3. The documents proving the satisfaction of eligibility requirements specified in Clause 2 Article 8 of this Decree.

Article 10. Requirements for application for declaration of eligibility for manufacture of medical devices

1. A set of application for declaration of eligibility for manufacture of medical devices shall be prepared. To be specific:

a) Documents included in the application must be clearly printed and arranged in the order prescribed in Article 9 of this Decree; space must be provided between content parts in a document; the application must have covers and a list of documents.

b) Documents in a language other than English and Vietnamese must be translated into Vietnamese. Vietnamese translations must be notarized in accordance with regulations of law.

2. Requirements for some documents in an application for declaration of eligibility for manufacture of medical devices:

a) The original or certified true copy or copy bearing the applicant’s certification of the Certificate of conformity with quality control standards.

b) The originals bearing the applicant’s certification of documents proving its satisfaction of eligibility requirements as set out in Clause 2 Article 8 of this Decree.

Article 11. Procedures for declaration of eligibility for manufacture of medical devices

1. Before initiating manufacture of medical devices, the manufacturer shall submit an application for declaration of eligibility for manufacture of medical devices to the Department of Health of province where its factory is located (the manufacturer’s factory is specified in the certificate of quality control system). Where there are multiple factories located in different provinces, application for each province shall be submitted.

2. After receiving the application (including application fee receipt as prescribed by the Ministry of Finance), the Department of Health of province where the factory is located shall publish on the Portal on management of medical devices all information about and application for declaration of eligibility for manufacture of medical devices.

3. During its operation, the manufacturer shall prepare a notice of changes which is accompanied by supporting documents for such changes, and update such documents to its application for declaration of eligibility for manufacture of medical devices published on Portal on management of medical devices within 03 working days from the occurrence of such changes.