Regulations Amending the Precursor Control Regulations (Increased Regulatory Oversight) (19 pages, in English and French)

FDA Circular "Guidelines on the Regulation of Medical Device Software (MDSW) by the Food and Drug Administration (FDA)"; (7 page(s), in English)

Implementing Guidelines of the World Health Organization (WHO) Collaborative Procedure on the Registration of Pharmaceutical Products Approved by Stringent Regulatory Authorities (SRAs); (9 page(s), in English)