I tried to find a proximately how long cofeprise t
Post# of 75357
(Total Views: 591)
Posted On: 09/19/2018 10:01:53 AM
I tried to find a proximately how long cofeprise takes to issue permits and this is what i found, i know this is for medical devices, but just gives you an idea about the process.
How are medical devices registered in Mexico?
MV: Healthcare products in Mexico are registered through the Federal Commission for Protection of Sanitary Risks (COFEPRIS). COFEPRIS has three processes for the registration of medical devices: the standard method, the fast-track option, and the recently-introduced third-party review. In order to obtain a license through any of these processes, foreign manufacturers must have approval in their country of origin and appoint a registered Mexican Registration Holder (MRH) in Mexico to conduct registration on their behalf.
Though official times are much shorter, registration in Mexico can take as long as 1-2 years. Since this is a very long time for most manufacturers, the fast-track option was introduced to expedite the process according to equivalency agreements with Health Canada, the American Food and Drug Administration (USA FDA), and the Japanese Ministry of Health, Labour, and Welfare (MHLW)*.
Q2: How does the fast-track option work?
MV: The fast-track option applies to all classes of devices that have already obtained certification from Health Canada, the USA FDA, or the Japanese MHLW, except for devices classified by Health Canada or the Japanese MHLW as Class I. COFEPRIS has agreed with the assessments of Health Canada, the USA FDA, and the Japanese MHLW and strongly takes their decisions into account when making their own evaluation.
In practice, this means that COFEPRIS asks for less documents, as little as half of the documents required through the standard track, and issues approval much more quickly. Instead of requiring a full report, for example, they may accept a summary only. Though, again, the official time is shorter, our experience is that a license is typically issued in 4-5 months.
Q3: In which case should manufacturers register their product or products through the fast-track process?
MV: If the manufacturer is registering a product that qualifies for the fast-track and they can obtain all the required documents, they should definitely use the fast-track option.
Legal documents required for the fast-track differ between Health Canada and the USA FDA, but are similar, while technical document requirements are the same. COFEPRIS requires different more legal documents and less technical documents based on the equivalency agreement with the Japanese MHLW, which was introduced later. If the manufacturer is registering the device according to the USA FDA certification, they must ensure that they have an Establishment Inspection Report from the USA FDA. If they don’t have this report, COFEPRIS will not approve the registration process through the fast-track.
Since this inspection is performed by the USA FDA arbitrarily, this can be a problem for manufacturers who have not undergone the inspection, with the exception of manufacturers of Class III medical devices (for which the inspection is mandatory). As such, manufacturers of devices classified as Class I and/or Class II exempt from Good Manufacturing Practice Inspection (GMP), cannot comply with this particular requirement from COFEPRIS because they cannot provide this report.
In the case of Health Canada, if the manufacturer does not have a CAN/CSA – ISO 13485 Certificate or if such a certificate has been issued by a registrar that has not been accredited in the list of recognized registrars of Health Canada, it is also not possible to use the fast-track option for expedited registration.
Q4: What are some of the challenges associated with the fast-track process?
MV: The biggest challenge with the fast-track is time. Unlike the lengthy standard process, if COFEPRIS asks for additional documentation or clarification, they may require an answer within a very short period, something like 15 working days, and the manufacturer must restart the process if they cannot meet the provided deadline or COFEPRIS does not accept their answer. If the documents are not already prepared, this can be very challenging. However, unlike the standard process, registrants going through the fast-track are provided with a direct email address through which they can receive feedback on general questions much more quickly.
Some requirements are still not completely clear, though COFEPRIS will accept explanatory letters if the circumstances call for one in most cases. Not all evaluators will make the same non-official recommendations when asked questions, so this can also cause some confusion.
Another challenge that is the same for all tracks of registration is that COFEPRIS’ online system will only tell you if the license is under review or issued, but will not provide additional information regarding the stage of the review process. Also, it is not possible to contact the evaluator of COFEPRIS, who is anonymous, to ask for additional information of the process.
Q5: What recommendations would you make to manufacturers who are ineligible to use the fast-track but are reluctant to undergo the standard process?
MV: Unfortunately, many devices are not eligible for the fast-track, but COFEPRIS recently introduced a third-party review option for manufacturers whose products are Health Canada Class I or Japanese MHLW Class I, are not registered with Health Canada, the USA FDA, or the Japanese MHLW, or cannot obtain the necessary documents to qualify for the fast-track. Though more expensive, the third-party review is significantly faster and should be completed within 1-2 months since COFEPRIS must only approve the review of the authorized third-party.
How are medical devices registered in Mexico?
MV: Healthcare products in Mexico are registered through the Federal Commission for Protection of Sanitary Risks (COFEPRIS). COFEPRIS has three processes for the registration of medical devices: the standard method, the fast-track option, and the recently-introduced third-party review. In order to obtain a license through any of these processes, foreign manufacturers must have approval in their country of origin and appoint a registered Mexican Registration Holder (MRH) in Mexico to conduct registration on their behalf.
Though official times are much shorter, registration in Mexico can take as long as 1-2 years. Since this is a very long time for most manufacturers, the fast-track option was introduced to expedite the process according to equivalency agreements with Health Canada, the American Food and Drug Administration (USA FDA), and the Japanese Ministry of Health, Labour, and Welfare (MHLW)*.
Q2: How does the fast-track option work?
MV: The fast-track option applies to all classes of devices that have already obtained certification from Health Canada, the USA FDA, or the Japanese MHLW, except for devices classified by Health Canada or the Japanese MHLW as Class I. COFEPRIS has agreed with the assessments of Health Canada, the USA FDA, and the Japanese MHLW and strongly takes their decisions into account when making their own evaluation.
In practice, this means that COFEPRIS asks for less documents, as little as half of the documents required through the standard track, and issues approval much more quickly. Instead of requiring a full report, for example, they may accept a summary only. Though, again, the official time is shorter, our experience is that a license is typically issued in 4-5 months.
Q3: In which case should manufacturers register their product or products through the fast-track process?
MV: If the manufacturer is registering a product that qualifies for the fast-track and they can obtain all the required documents, they should definitely use the fast-track option.
Legal documents required for the fast-track differ between Health Canada and the USA FDA, but are similar, while technical document requirements are the same. COFEPRIS requires different more legal documents and less technical documents based on the equivalency agreement with the Japanese MHLW, which was introduced later. If the manufacturer is registering the device according to the USA FDA certification, they must ensure that they have an Establishment Inspection Report from the USA FDA. If they don’t have this report, COFEPRIS will not approve the registration process through the fast-track.
Since this inspection is performed by the USA FDA arbitrarily, this can be a problem for manufacturers who have not undergone the inspection, with the exception of manufacturers of Class III medical devices (for which the inspection is mandatory). As such, manufacturers of devices classified as Class I and/or Class II exempt from Good Manufacturing Practice Inspection (GMP), cannot comply with this particular requirement from COFEPRIS because they cannot provide this report.
In the case of Health Canada, if the manufacturer does not have a CAN/CSA – ISO 13485 Certificate or if such a certificate has been issued by a registrar that has not been accredited in the list of recognized registrars of Health Canada, it is also not possible to use the fast-track option for expedited registration.
Q4: What are some of the challenges associated with the fast-track process?
MV: The biggest challenge with the fast-track is time. Unlike the lengthy standard process, if COFEPRIS asks for additional documentation or clarification, they may require an answer within a very short period, something like 15 working days, and the manufacturer must restart the process if they cannot meet the provided deadline or COFEPRIS does not accept their answer. If the documents are not already prepared, this can be very challenging. However, unlike the standard process, registrants going through the fast-track are provided with a direct email address through which they can receive feedback on general questions much more quickly.
Some requirements are still not completely clear, though COFEPRIS will accept explanatory letters if the circumstances call for one in most cases. Not all evaluators will make the same non-official recommendations when asked questions, so this can also cause some confusion.
Another challenge that is the same for all tracks of registration is that COFEPRIS’ online system will only tell you if the license is under review or issued, but will not provide additional information regarding the stage of the review process. Also, it is not possible to contact the evaluator of COFEPRIS, who is anonymous, to ask for additional information of the process.
Q5: What recommendations would you make to manufacturers who are ineligible to use the fast-track but are reluctant to undergo the standard process?
MV: Unfortunately, many devices are not eligible for the fast-track, but COFEPRIS recently introduced a third-party review option for manufacturers whose products are Health Canada Class I or Japanese MHLW Class I, are not registered with Health Canada, the USA FDA, or the Japanese MHLW, or cannot obtain the necessary documents to qualify for the fast-track. Though more expensive, the third-party review is significantly faster and should be completed within 1-2 months since COFEPRIS must only approve the review of the authorized third-party.
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