Vietnam Deficiency Responses: 90-Day Window and Three-Response Cap

Q: Once Vietnam requests a deficiency response, what rules apply?

A: Under Article 32(3)(c) of Decree 98 as amended by Decree 07/2023/NĐ-CP, the rule is a double cap:

• Time cap: where the applicant has neither responded nor supplemented within 90 days of the date the MOH issues the deficiency notice;
• Count cap: where, after three deficiency responses counted from the first notice issued by the MOH, the file still does not meet requirements.

If either cap is triggered, the procedure for the circulation number must be repeated from the beginning.

Q: Why is this rule dangerous?

A: Because it turns the deficiency response from a process of repeated trial and error into a hard limit on both count and time. Many manufacturers assume that a returned file can simply be supplemented again. In Vietnam that assumption leads directly to the file being voided, the official fee not being refunded and the time cost doubling. The subtler risk is that the deficiency notice may be served on the MAH only through the portal or in writing, and if the MAH does not pass it on promptly, the window lapses in silence.

Q: What should be done on receiving a deficiency notice?

A: Four steps. First, confirm the original notice in Vietnamese on the same day, translate it item by item and align it with the technical team. Second, judge feasibility: is this a matter of supplying a missing document, or of running additional testing or clinical work, and in the latter case assess the lead time. Third, respond completely in a single round rather than submitting in batches, because the cap is only three. Fourth, keep a record: archive the submission receipt and screenshots of the portal status.

Q: When is a file rejected outright rather than given a deficiency?

A: Usually where the applicant’s standing or the authenticity of a document is at issue. Examples include an invalid or expired LoA, an ISO 13485 certificate not issued by an IAF-recognised body and therefore not accepted, a CFS issued by a body Vietnam does not recognise, and an incomplete notarisation and legalisation chain. These go to the foundation of the file and usually attract no opportunity to respond.

Practical note: build a deficiency countdown board. From the day the notice arrives, set reminders on two dimensions, the 90 days and the remaining number of responses, with three checkpoints at days 30, 60 and 80, and copy the original notice and the submission receipt to the manufacturer. On Vietnamese projects GRZAN requires the MAH to commit in the service agreement to forward any notice within 24 hours, and this is the most effective single measure for reducing deficiency risk.

Verification checklist (26 October 2026): (1) Article 1(3) of Decree No. 07/2023/NĐ-CP, amending Article 32(3)(c) of Decree 98 (90 days, three deficiency responses, restart); (2) the current text of Article 32 of Decree 98/2021/NĐ-CP; (3) Article 147 of Decree 96/2023/NĐ-CP (prioritized processing cases, including those where a deficiency is raised or a file refused over the validity of the LoA, ISO certificate or marketing authorisation); (4) the MOH/IMDA portal mechanism for serving deficiency notices.