Knowledge base
Certification-rule amendments covering GMP and ISO 13485 — No. 3386-2
Certification amendments containing GMP, ISO 13485 and documentation provisions. Dates in 2027 appearing in the text are not presented as having already occurred at the review date.
- Act type
- Order of the Minister of Health
- No.
- 13
- Adopted
- 16 December 2025
- Ministry of Justice registration
- No. 3386-2, 25 December 2025
- Section
- Quality, GxP and pharmacopoeia
Official text
Certification-rule amendments covering GMP and ISO 13485 — No. 3386-2
Order of the Minister of Health · No. 13 · 16 December 2025
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