With Morocco recording over 1,000 new COVID-19 cases every day, the need for the Moroccan-made medical devices could be more urgent than ever.
Rabat – Nearly five months after the Ministry of Health ordered 400 Moroccan-made ventilators, the invention is still unavailable in Moroccan hospitals.
According to a recent report by Le360, the ministry’s bureaucracy is to blame.
However, one Moroccan-made ventilator, developed by aeronautics factory SERMP and engineering company Aviarail, earned exceptional praise.
On April 8, Minister of Industry Moulay Hafid Elalamy visited its production unit and announced a public-private partnership to make the Moroccan ventilators available in hospitals.
Ministry of Health’s order
Soon after the visit, the Ministry of Health placed an order of 400 ventilators to supply Moroccan hospitals. However, to date, the ministry did not authorize the delivery of the medical equipment.
In early June, a video report revealed that SERMP and Aviarail had already produced approximately 50 ventilators, while over 100 more were in the final stage of production.
The companies, however, decided to slow down the ventilators’ production, pending the delivery of the first batch to the Ministry of Health.
Based on statements from several stakeholders cited by Le360, the production companies have already gone through a series of administrative steps to accelerate the delivery of ventilators to Moroccan hospitals, but to no avail. The companies have also spent MAD 8.1 million ($885,000) to accelerate their production chain.
One week after the Ministry of Health placed its order, on April 13, a delegation of military doctors visited the production unit to inspect the Moroccan-made ventilators and approved of their quality.
On April 25, a medical expert designated by the ministry led the first medical trial of the Moroccan ventilators on a living creature—a young sheep. The test gave positive results.
After the first test, the Ministry of Health created a scientific committee including 10 intensive care doctors from 10 university hospitals across Morocco.
On May 12, the scientific committee approved the Moroccan ventilators after a presentation at the production unit in Casablanca. The approval meant that the Ministry of Health can begin the reception of the first lot of ventilators.
However, after the approval, the ministry issued a list of procedures that the manufacturing companies must go through before delivering their invention.
“We could have launched these procedures since late April if the ministry had told us,” a member of the production team told Le360.
Lengthy administrative process
Following the ministry’s instructions, SERMP and Aviarail began the administrative process in early June. The companies have already achieved several steps, including the acquisition of a medical certification, the registration of the production unit as a medical production unit, and the conduction of further technical and scientific tests.
According to Le360, on August 17, while the companies were almost finished with the various legal and administrative procedures, the Ministry of Health imposed a new digital administrative step.
The Ministry of Health, however, pledged to accelerate this “final” digital process. Despite its promise, the ministry required additional documents before the completion of the process.
Ministry of Health’s response
In a letter addressed to Le360 on August 25, the Ministry of Health attempted to justify the complicated administrative procedures and announced an upcoming meeting to evaluate the documents from the manufacturing companies.
According to the letter, the lengthy process aims to ensure the safety, efficiency, and high quality of the Moroccan-made ventilators before their use in hospitals.
The Ministry of Health shared a list of the final seven steps that SERMP and Aviarail need to take before the ventilators’ purchase can be finalized.
The first step is the declaration of one of the manufacturing companies as a producer of medical equipment. Then, the companies must present a document that testifies that the Moroccan ventilators respect the conditions set by the ministry.
Third, the companies must list all their partners in the production process and present their subcontracting contracts.
The fourth requirement is a document that lists all the steps of the manufacturing process, including the various tests done to ensure the ventilators’ quality.
Fifth, the companies must present a technical document that includes proof of the safety and efficiency of the Moroccan ventilators, details about raw materials used and their origin, details about the equipment used in the manufacturing process, and information regarding the sterilization process at the production unit.
The sixth required document is a pledge to apply for an ISO 13485 certificate or a similar certification for medical devices.
The final requirement is a labeling model for the Moroccan ventilators to identify each of the devices.
Urgent need for ventilators
The Ministry of Health claimed that it has only received some documents with a general presentation of the Moroccan-made ventilators and the results of preclinical trials on a sheep.
The government department also assured that it will accelerate the delivery process once it receives all the required documents.
In consideration of all the remaining requirements, it seems that Moroccan ventilators will not be available in hospitals for several weeks, if not months.
With dozens of coronavirus-related deaths recorded every day, as well as a rise in the number of COVID-19 patients in intensive care units, the need for the Moroccan ventilators could soon be felt in hospitals across Morocco.
However, it remains to be seen whether COVID-19 can soften the complicated administrative processes, or if bureaucracy will persist despite the global pandemic.