This Official letter is to reply to some issues relating to procedures for import of medical devices according to Decree No. 98/2021/ND-CP .
Accordingly, based on point c clause 2 Article 76 of Decree No. 98, import licenses issued according to regulations of Circular No. 30/2015/TT-BYT shall be still valid until December 31st, 2022. With regard to Circular No. 30/2015/TT-BYT , the Ministry of Health is reviewing and proceeding procedures for declaration of its expiration.
With regard to medical devices regulated at point d clause 2 Article 76 of Decree No. 98/2021/ND-CP (medical devices which are not subject to the import license and have been classified as class-C or D medical devices as published on the Ministry of Health’s Portal), enterprises may continue to import them until the end of December 31st, 2022 and may use the classification result to carry out procedures for customs clearance (instead of the confirmation as medical devices from the Ministry of Health), not depending on time when the classification result is declared on the Ministry of Health’s Portal is before or after January 1st, 2022.
When importing unregistered medical devices to serve display at trade fair, exhibition, enterprises have to apply for the import license according to the regulations at point c clause 1 Article 48 of Decree No. Decree No. 98/2021/ND-CP.
In principle medical devices placed on the market must meet the condition on being granted registration number or import license, except the cases not applying the regulations on classification, issuance of registration number, and eligibility requirements for trading of medical devices specified in Clause 8 Article 3 and cases of exemption from requirements for declaration of applied standards and registration specified at Article 24 of Decree No. 98/2021/ND-CP.
With regard to unregistered medical devices that are needed to be imported as assistance; to serve scientific research, testing, inspection, etc. it is allowable to apply the form of issuance of license to import according to a specific amount according to Article 48 of Decree No. 98/2021/ND-CP.