Overview
In August 2023, Mexican regulators have updated guidance on rules for modifications to medical device registrations that could streamline COFEPRIS reviews.
Introduction
COFEPRIS, Mexico’s medical device market regulator, has issued updated instructions on changes to device registrations to improve review processes and eliminate backlogs.
In early August, COFEPRIS issued a statement (COFEPRIS-CFS-325-2023) announcing that new “classification” criteria for modifications to Sanitary Registrations for medical devices (as well as products such as vitamins, pharmacochemical substances, biologics, and biotechnological products) would be released soon. The new criteria are intended to minimize the regulator’s review backlog. The new categorization criteria will go into effect on August 28, 2023, replacing the old criteria that went into force in February 2022.
OFICIO-CFS-325-2023 contains vital information about the submission process. Modifications must now be submitted electronically (albeit in person, using a properly marked USB flash drive storage media).
COFEPRIS rules for changes to the health register have been revised:
COFEPRIS issued a revised guideline on August 9 (Gua De Criterios Para Clasificación de Modificaciones de Registros Sanitarios de Dispositivos Médicos) in response to OFICIO-CFS-325-2023, establishing the criteria and procedures for the modification of sanitary registrations of medical devices.
The guideline starts with references to the existing regulatory framework that covers modification needs, such as the General Health Law, Health Supplies Regulation, Mexican Pharmacopoeia, and subsequent agreements published in 2011, 2015, and early 2022. It defines the terms Manufacturer, Legal Manufacturer, and Real Manufacturer to make the applicable amendments clearer:
- Legal manufacturer: Entity responsible for the safety, performance, and quality of a system, or the restoration, modification, or adaptation of a medical device prior to its commercialization.
- Real manufacturer: The entity in charge of manufacturing, assembling, or remanufacturing a medical device.
Significant Revisions to the New COFEPRIS Guideline
Important changes to the new guidelines
- Product formulation.
- Original registration route must be maintained through subsequent modifications.
- Ensure that the registration route selected is the best for the device throughout its life cycle.
Administrative modifications COFEPRIS-2022-022-003-A for homoclaves include:
- Technical changes.
- Change of address of local or foreign distributor
- Change
- Change of distributor.
- Change of company name of the actual manufacturer.
- Change of company name and address of the legal manufacturer.
- Change of trade name or product catalog number.
- Change of secondary packaging material.
- Removal of sales presentations.
- Removal of distributors and/or manufacturer.
Technical modifications to the COFEPRIS-2022-022-004-A homoclave include:
- Change of manufacturing sites (provided they are branches or subsidiaries).
- Change of contract manufacturer (maquila).
- Reclassification of the medical device.
- Change of primary and secondary packaging material
- Change of expiry date.
- Additions to models that do not represent technological advances or change the main intended use.
- Change of formulation (not involving the replacement of the active ingredient or affecting the intended use).
Modifications to the transfer of rights within the COFEPRIS-2022-022-005-A homoclave include:
- Change of registry holder.
- The guideline mentions that when the registry holder in Mexico (MRH) is listed as an importer or distributor, changes to the transfer of rights can also tolerate changes to the section of the registry relating to the importer and distributor.
Documentation and definition changes
The requirements of the documents remain largely unchanged, but the definitions are updated to reflect the concepts listed in the Medical Device Supplement 5.0.
Additional Updates:
- Address updates resulting from change.
- Changes of address or company name for the legal manufacturer will now require updated legal letters of representation issued by the manufacturer to the registration holder and distributors.
- Legal manufacturers can be added even without a CFS (or equivalent), if there is documentation proving the relationship between the interested parties.
- Legal documents must be less than 30 months old when their validity periods have not been specified.
- It has been defined that, whenever a CFS is a requirement, it must contain the product’s trade name, models, code list and manufacturer information.
- All the information required in a Certificate of Analysis.
- Changes to condom registrations will require certificates of analysis issued by local laboratories.
- Requirements for shelf-life modifications include precise details reflecting recent updates to the Supplement.
- Formulation changes must submit a formulation statement signed by the responsible quality representative, stability or ageing studies and certificates of analysis.
GRP Mexico Closing Comments
Global Regulatory Partners Mexico believes that this guidance is intended to align COFEPRIS reviewers and set user expectations. In addition, it seems that truly administrative modifications are intended to be reviewed more quickly. Minor and moderate modifications to the registrations of allopathic, herbal and homeopathic medicines will be approved immediately as of August 28, 2023, so we hope that this represents a step towards immediate approvals for administrative modifications of medical products in the near future, too.
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We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their products with the Mexico's Cofepris the local Health Authority (HA)
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We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product with the Food and Drug Administration (FDA) the local Health Authority (HA)
About Global Regulatory Partners Group
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.