On December 31, 2018, the Vietnam Ministry of Health (MOH) issued Decree No. 169/2018/ND-CP amending and supplementing some articles of Decree No.36 on Medical Device Management and took effect from the date of signing.
1) Decree No. 169 has amended and supplemented regulations regarding to Medical Device Management as follows:
• Explain the definition of medical device;
• Classification of medical device;
• Conditions of establishments that classify, produce and trade medical device;
• Procedures for declaration, registration for circulation and importation of medical device;
• Activities of inspection and calibration of device;
• Management and use of medical device in medical facilities;
• Organization of implementation.
2) Decree No.169 has amended and supplemented provisions on transitional provisions in Article 68 of Decree No.36 with the following contents to be noted:
• Import licenses for class B, C and D medical device expired on December 31, 2018 and those import licenses will be issued in 2019 are valid until the end December 31, 2019.
• For class A medical device, there is a receipt note for applicable standard declaration issued by the Department of Health, which is imported according to demand without quantity restriction and without the confirmation letter from MOH to confirm it is medical device prior customs declaration procedures.
• For medical devices not included in the list of goods that must be granted import licenses and classified as class B, C, and D medical device by the organizations which was published into the electronic portal by MOH will continue to be imported until December 31, 2019 on demand, without any quantity restriction andconfirmation letter from MOH.
• MOH began to receive registration application for all class B, C, and D medical devices from July 1, 2017 and the registration number will be effective from January 1, 2020.
• IVD devices have been granted registration certificates in accordance with the Law on Pharmacy in 2005 and documents guiding the implementation of this Law, the validity of registration numbers has been valid until the end of the time stated on the registration certificates. Particularly for registration numbers of IVD expired after January 1, 2019 and before December 31, 2019 will continue to be used until the end of December 31, 2019.
• IVD devices submitted the application for registration in accordance with the Pharmacy Law 2005 before January 1, 2019, will be resolved under the provisions of the Pharmaceutical Law 2005.
• Imported IVD devices apply the submission in the period from January 1, 2019 to the end of December 31, 2019, which are granted import permits according to the provisions of the Pharmaceutical Law 2005 and valid until December 31, 2019.
• The domestic manufactured medical device which has been granted the registration certificate, the validity of the granted registration number shall be valid until the end of the time stated in the registration. Particularly for registration certificates which expire after the effective date of this Decree and before December 31, 2019, shall continue to be used until the end of December 31, 2019.
• Organization conducting classification of medical device is responsible for completing the publicity of medical device classification results issued before December 31, 2018 on the electronic portal of the MOH at: www.dmec.moh.gov.vn before April 1, 2019.
• All certified certificates of medical device classification issued before December 31, 2018 are valid for only 3 years from the date of signing.
• The holder of registration number must review the results of classification of medical device according to the provisions of Clause 2, Article 4 of this Decree and report them to the Ministry of Health before July 1, 2019.
• ASEAN General Technical Document (CSDT) will be implemented from July 1, 2020.
• Medical gas production facilities must complete the application of ISO 9001 quality management system or equivalent from January 1, 2020. Other facilities continue to comply with the provisions of the Decree. No. 36/2016 / ND-CP.
Should you have further questions about Decree No. 169, please do not hesitate to contact us for more clarification.