In order to assist applicants in not having to supplement their dossiers many times and speed up the appraisal of dossiers and issuance of product registration numbers of medical equipment, the Ministry of Health provided instructions with 2 main points as below:
- 1. The time to supplement a dossier is 90 days from the date received notification from the Ministry of Health. There are only 5 chances for dossier supplementation. After 05 times of supplement, if the dossier still does not meet the requirements, the procedure must be repeated from the beginning.
- 2. Requirements for brief description:
- - For medical equipment products that are intended only for disinfection of the medical equipment, the brief description must be included composition, content of substances with antiseptic activity, biocompatibility, bioavailability, safety of products together with supporting documents and used the template 1, Annex VIII of Decree số 36/2016/NĐ-CP;
- - For IVD products (reagents, calibrators, in vitro control materials), applicants have to provide documentation of materials, product safety, manufacturing procedures, clinical and pre-clinical research reports including stability reports. All the information must be shown by using the template 2, Annex VIII of Decree 169/2018/NĐ-CP.
Written no.939/BYT-TB-CT providing instructions for registration of medical equipment products.