Injectable rules to be revised
The Department of Health (DH) has planned to revise the Codes of Practice (CoPs) to require that all injectable and infusible products used in licensed private healthcare facilities (PHFs) must fall within three categories.
In response to media enquiries today, the department reminded the public that injection procedures should only be administered by registered medical practitioners or registered dentists.
It stated that since injectable and infusible products intended for human use are high-risk products, the Advisory Committee for Regulatory Standards for Private Healthcare Facilities has endorsed updated regulatory requirements and required that all injectable and infusible products used in licensed PHFs must fall within three categories.
These include Pharmaceutical products registered or exempted from registration under the Pharmacy and Poisons Regulations, Human organ or human tissue products in compliance with the Human Organ Transplant Ordinance, or Medical devices listed under the Medical Device Administrative Control System (MDACS).
In light of the Advisory Committee's decision, the DH will revise the CoPs for licensed PHFs accordingly and plans to publish them in the Gazette in the fourth quarter this year.
The revised CoPs, except for the sections on medical devices, will take effect one month after publication in the Gazette.
To allow licensed PHFs sufficient time to identify compliant alternative products, the relevant requirement for using injectable and infusible medical devices listed under MDACS will take effect on March 1, 2027.
The department issued a letter on September 9 to notify licensees of PHFs, licence applicants and the medical device industry of the aforesaid requirement. The letter, as well as frequently asked questions, can be viewed online.