APPLICATION FOR HEALTH REGISTRATION
Through Communiqué No. 27-2024, the Digemid informed that, through the virtual desk, applications for registration or re-registration of health registrations for the treatment of rare or orphan diseases that have been registered in any of the countries with high health surveillance, in accordance with Article 9 of Law No. 29698, modified by Law No. 31738, can be managed.
REGULATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
Currently, in vitro diagnostic medical devices do not have a special regulation and are governed by Supreme Decree N°010-97-SA.
Ministerial Resolution No. 607-2024/MINSA, dated September 10, 2024, published the draft “Regulation for the registration, control and health surveillance of in vitro diagnostic medical devices” which seeks to regulate this type of devices, as well as their accessories.
MINSA will receive comments within ninety (90) calendar days from the day following its publication.
CERTIFICATION IN GOOD MANUFACTURING PRACTICES (GPM)
Ministerial Resolution No. 615-2024/MINSA modified the “Administrative Directive for the Certification of Good Manufacturing Practices in National and Foreign Laboratories”.
Several provisions were modified, such as the modification of Annexes 02, 03-A and 03-B and the obligation to request the Good Laboratory Practices (GLP) certification to the Customer Service and Case Management Area of the DIGEMID was incorporated.
GRANTING OF GLP CERTIFICATION
Through Ministerial Resolutions No. 604, 603, 602, 601-2024/MINSA, Digemid officials were authorized to travel to carry out inspections to laboratories in Argentina, Ecuador and Paraguay in order to grant GMP certification.
TREATMENT WITH MODELING SUBSTANCES
Law No. 32118 amended the “Law that regulates the use of modeling substances in body treatments for aesthetic purposes and defines this procedure as a medical act” (Law No. 31014).
The main modified points:
The use of non-biodegradable and non-absorbable substances is allowed, as long as they are on the list of modeling substances approved by MINSA.
Specialists in ophthalmology, head and neck surgery, otorhinolaryngology, gynecology or urology “trained to perform aesthetic treatments” are allowed to perform this medical act.
It is also allowed to perform body treatments to the duly registered surgeon with a university postgraduate degree with no less than two years of duration of master’s level in Aesthetic Medicine.
TECHNICAL STANDARD FOR FIRST LEVEL ESTABLISHMENTS
Ministerial Resolution No. 637-2024/MINSA modified the Technical Health Standard NTS No. 113-MINSA/DGIEM-V.01 “Infrastructure and Equipment of First Level Health Care Facilities”.
Several technical rules related to the characteristics of the land allowed for the construction of this type of establishments were modified.
HEALTH AUTHORIZATION OF BLOOD BANKS
By means of Supreme Decree No. 017-2024-SA, the presentation of the application for Sanitary Authorization of Blood Banks, contained in the Sole Transitory Complementary Provision of Supreme Decree No. 017-2022-SA, was extended for 6 months, starting on September 14, 2024.
ELECTRONIC CIGARETTES – DRAFT LAW
On September 19, 2024, the “Substitute text of bills 3412, 3437, 3732, 4178 and 4717, which proposes to regulate the control of the consumption of tobacco products, nicotine or substitutes of both for the protection of life and health” was approved in the first vote of the Plenary of Congress.
This legal proposal seeks, among other measures, to equalize the treatment of electronic cigarettes to that of tobacco cigarettes, covering aspects such as consumption in public places, advertising, labeling and warnings.
MEDICAL CANNABIS
Colombia’s Ministry of Health published the draft Decree “Whereby Title 11 of Part 8 of Part 8 of Book 2 of Decree 780 of 2016 Sole Regulatory Decree of the Health and Social Protection Sector is partially modified, in relation to safe and informed access to the use of cannabis and the cannabis plant.”
This is the modification of the regulation governing medical cannabis in Colombia. The most relevant modification is that the medicinal use of the flowering or fruited tops of the plant is allowed.
FDA AUTHORIZES MEDICAL SOFTWARE
In a press release, the FDA reported that it authorized the marketing of the first over-the-counter medicated hearing aid software. This software is compatible only with Apple brand wireless hearing aids and serves people with mild to moderate hearing loss, without the need for a professional fitting. They will be able to customize the software themselves (self-fitting strategy).
The authorization procedure followed a special, low-risk de novo premarket review pathway for novel medical devices.
