Armenia medical device regulatory resources

Paragraph 50 of the Rules (Annex No. 2 to EEC Council Decision No. 46 of 12 February 2016, as restated by EEC Council Decision No. 144 of 24 December 2021): 'The authorized authority (expert organization) of the Member State concerned shall consider the expert report within 30 business days, calculated from one of the following dates: when the procedures of marketing authorization and expert examination of a medical device are carried out – from the date of receipt of a notice on payment for the approval procedures by the authorized bodies (expert organizations) of the reference Member State and the Member State(s) concerned'. Recorded in working-days, the same measure as the text's 'business days'.

This replaces the earlier note on this row that no published clock had been found: the Rules do fix a clock for Armenia's own market-access decision, and paragraph 50 is it. It is the tail of the procedure rather than the whole of it — paragraphs 28, 29, 30, 31, 32, 35, 36 and 40 clock the applicant, the reference Member State and its inspecting organisation on the earlier stages.

The start trigger is not the application date: the 30 business days runs from receipt of the payment notice and of the applicant's funds in the Member State concerned's account, so an unpaid approval fee stops the period. The applicant's own 60-business-day response window (paragraph 28) and 30-calendar-day payment window (paragraph 36) sit outside it.

The class split matters for the duty, not for the clock: the Law on State Duty prices these devices at AMD 10,000 and AMD 20,000 respectively.

Same paragraph 50 clock as the lower classes — 30 business days for the authorised authority of the Member State concerned to consider the expert report — because paragraph 50 is class-neutral. The class distinction in Chapter II operates on whether a production-facility audit is required, not on the consideration period.

The class-dependent stage is the audit, which paragraph 30 puts at not more than 90 business days from the reference Member State's decision to start it, with the audit report due within 15 business days of completion (paragraph 31) and the expert report within 15 business days of the audit report (paragraph 32). All of those bind the reference Member State or its inspecting organisation, not Armenia, so a class 2b or class 3 file reaches Armenia's 30-business-day consideration later than a class 1 or class 2a file, but the consideration itself is the same period.

State-duty rates for these devices are AMD 20,000 (class 2b, priced in the class 2 band) and AMD 30,000 (class 3).

Paragraph 29 of the Rules, Chapter II: 'The authorized authority (expert organization) of the reference Member State shall, within 45 business days from the date of its decision to start the marketing authorization and expert examination procedures in respect of the medical device, draw up an expert report in accordance with Annex 5 or, if required, makes a decision to start the audit of the production facilities ... and notify the applicant of its decision'.

Recorded as a separate row because it is a different authority role with a different clock, and it must not be added to paragraph 50's 30 business days — the reference-side stage and the Member-State-concerned stage run in sequence, not in parallel.

The rest of the reference-side sequence is also clocked by the Rules: audit not more than 90 business days from the decision to start it (paragraph 30); audit report within 15 business days of completion, or of the applicant's notice of nonconformity elimination (paragraph 31); expert report within 15 business days of the audit report (paragraph 32); refusal decision within 10 business days of a negative expert report (paragraph 35); placement in the information system and notice of payment within 5 business days of a positive expert report (paragraph 36); decision on registration and issue of the marketing authorisation each within 10 business days (paragraphs 40(a) and 40(b)). All of those bind the authority side, not the applicant.

The realistic range adds the applicant-side gaps between the staged clocks — the 60-business-day response window under paragraph 28 and the 30-calendar-day payment round-trip under paragraph 36 — which is why the row is in months while the published clock is in days.

Decree No. 429-Ն paragraph 19 caps the whole run from registration of the application and the required documents in the authorised body to the result at five working days for registered medical devices; paragraph 16 gives the expert organisation four working days of that for a registered device, paragraph 17 gives the authorised body one working day for the decision, and paragraph 20 allows two more working days if a paper copy of the certificate is also requested.

Paragraph 19 allows the authorised body to extend the cap by up to 10 working days for clarifications on quality and safety issues; the paragraph 14 cure time is excluded.

The clock is keyed to registration status, not to risk class, which is why this row and the next are not class rows.

The realistic range adds the applicant's own document-preparation time, which the decree does not clock.