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Imported Non-Sterile Medical Devices Meant For Sterile Use
Need Mandatory Registration
The Central Drugs Standard Control Organisation (CDSCO)
has made it clear that all imported non-sterile medical devices, if
meant to be used as sterile devices in the country, are subjected to mandatory
registration. The clarification comes after it was found that many medical
devices as imported as non-sterile and later sterilized by hospitals before use.
The clarification would ensure that all such devices, especially orthopaediac
devices come under the purview of regulatory mechanism.
According to the CDSCO clarification, the matter was examined by an expert
committee, which felt that all medical devices if the end use is after
sterilization should come under registration requirement and import license as
per the Drugs and Cosmetics Rules. The committee also stated that 'batch release
certificate' will only be required for those devices, which contain biological
products of animal and human origin.
The national level study, commissioned by the Union Ministry of Health and
Family Welfare had highlighted the importance of comprehensive regulation of
medical devices. The study had called for the preparation of an inventory of
products and product groups of various medical devices and equipment that are
available in the market. It had also mentioned that the regulation of medical
devices is an excellent opportunity for the generation of revenue for the
department. The licensing would bring in revenue, apart from ensuring safe and
quality healthcare for the general population, it had noted.
It is felt that majority of medical devices are still outside the purview of
mandatory registration. The study had recommended regulation of import of
devices through import licensing, registration etc., certification of testing
laboratories for quality control, pre-market certification, surveillance and
notification, enforcement and post marketing follow up (leading to even recall
of products) for improving the quality of such products.
(Ref : Chronicle Pharmabiz dated September 28, 2006)
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