CDSCO issues notices to port offices for clarity in dealing with imported medical devices

PSM News /

Mumbai, November, 2017:

 

Central Drugs Standard Control Organization (CDSCO) has issued notices to port offices towards clarity in dealing with imported consignments of Medical Devices and IVDs held at the port offices. This is primarily being done for better enforcement of compliance in line with ease of doing business.

 

The notice states that it has been observed that despite holding the valid registration certificate and import licenses by the importers, some of the medical devices and diagnostics consignments are being withheld at the various port offices by the office of assistant drug controller (ADC) due to confusions in the name of the product vis-a-vis name in registration certificate or import licence.

 

Others reasons are due to inprocess applications, during change in constitution because of mergers or acquisitions, due to varying shelf-life issues in multicomponents kits, which is creating hurdles for importers, regulators and other stakeholders.

 

Therefore, in such cases of confusions in names of products, it is to clarify that if the authorized person of the importing firm furnishes the undertaking to office of ADC at port that the imported product are the registered ones only, despite the apparent differences (to be described). Then such consignment shall be released and the copy of undertakings, bill of entries, registration certificate and import licenses shall be forwarded to CDSCO head quarters (HQ) through a separate e-mail.

 

Further, in case of change in constitution due to merger or acquisition for

existing registration certificate or import licenses, if the courts or competent authority have endorsed the change, it may be accepted by the ADC at ports.

 

If the importers have applied for such changes in registration certificate or import licenses within 90 days, their consignments shall be released accordingly based on existing valid registration certificate or import licenses, as per rule, based on such proofs and undertaking of their application for change to CDSCO headquarters.

 

Further, in multi-component kits, the assigned shelf life as per Form 10 or claim of products, can vary due to multcomponents, in such cases, the component or reagent having lowest expiry date shall be considered for calculation of shelf life or residual shelf life.