Global Regulatory Resources

Find medicinal-product manufacturing, GMP, inspections and corrective-action references.

Access the official adoption of the GMP guide for manufacturers, importers and exporters of human medicines, with its annex.

Locate device and IVD GMP, including Disposición 3266/2013, and related regulatory references.

Review the establishment declaration process under Disposición 8799/2025 for eligible Class I/II devices and Class A/B IVDs.

Identify the PIC/S medicinal GMP edition adopted in Australia and its local exclusions.

Review device conformity-assessment audit expectations and manufacturer and sponsor responsibilities.

Review general pharmaceutical GMP requirements in ANVISA’s linked legislation repository.

Read the amendment to Article 372 of the general pharmaceutical GMP resolution.

Review Brazilian device and IVD quality-system and manufacturing requirements.

Locate device and IVD classification, market authorization and essential-principles references.

Locate pharmaceutical GMP in Part C, Division 2 and other applicable drug and biologic provisions.

Review pharmaceutical quality systems, investigations, laboratory controls, complaints and release expectations.

GMP guidance for active pharmaceutical ingredients and their intermediates.

Annex 1 guidance for the manufacture of sterile drugs.

Find device licensing, quality-system certification, complaint, incident and recall requirements.

Locate quality-system, MDSAP, incident reporting and recall guidance through the official device index.

Understand Health Canada’s use of MDSAP for medical device quality-system oversight.

Review the pharmaceutical quality, manufacturing and marketing-authorization-holder statutory framework.

Locate pharmaceutical quality-system, manufacturing, laboratory, deviation and complaint requirements.

Locate official English registration, IVD, manufacturing and distribution regulatory references.

Review device manufacturing oversight, registrant responsibilities and quality-system controls.

Identify the revised device GMP and the supersession of the former 2014 GMP announcement.

Locate the legal framework, including Directive 2001/83/EC and Regulation (EC) No 726/2004.

Find pharmaceutical quality systems, QC, complaints, recalls, sterile manufacture, computerized systems and batch certification guidance.

Consult inspector-agreed interpretations on pharmaceutical quality systems, data integrity and manufacturing controls.

Access MDR, IVDR, implementing measures and conditional transition resources.

Find QMS, vigilance, post-market surveillance and transition interpretations for devices and IVDs.

Locate the governing statute for Indian drug and device regulation.

Locate drug manufacturing rules and Schedule M GMP materials alongside amendments.

Find revised Schedule M, corrigenda and implementation-related notifications.

Locate device and IVD rules, including the Fifth Schedule quality-management framework and amendments.

Access pharmaceutical GMP Regulation 7/2024 and its amendment, Regulation 7/2025, through BPOM’s guide directory.

Review practical questions on CPOB certification, manufacturing facilities, inspections and supporting documentation.

Review the health-supplies framework and its repeal and retention provisions affecting medical devices and IVDs.

Consult Article 2 and Annexes I and II, which Regulation 5/2026 expressly retains; other provisions were repealed.

Find the Ministry of Health’s device incident-reporting information and vigilance resources.

Review the ministry’s GMP oversight, manufacturer/importer approvals, inspections and certification responsibilities.

Search official pharmaceutical procedures, including manufacturing, quality documentation and inspected-site status.

Consult the Knesset’s law record, amendments and related subordinate legislation.

Find device registration, renewal, changes and supporting quality-documentation procedures.

Locate pharmaceutical GMP orders, inspection guidance and computerized-system references.

Distinguish pharmaceutical GMP, device QMS and gene/cellular/tissue-product GCTP inspection pathways.

Find PMD Act references and risk-based Japanese device approval and certification pathways.

Locate Japanese device and IVD quality-system requirements and ISO 13485 comparison materials.

Access drug and biologic registration guidance, including inspection, licensing, product-quality reporting and recall appendices.

Locate pharmaceutical GMP inspection guidance and manufacturing, import and wholesale licensing references.

Locate Act 737, the Medical Device Regulations 2012, establishment obligations and subsequent amendments and orders.

Find classification, conformity assessment, quality-system, GDPMD, registration and post-market guidance.

Locate the mandatory pharmaceutical GMP norm and its official publication reference.

Read the pharmaceutical GMP amendment affecting specified controls and imported biotechnology-product release.

Locate the current mandatory device manufacturing norm and official legal publication.

Locate the mandatory device technovigilance norm and its official publication.

Locate pharmaceutical GMP and distribution-code resources through Medsafe.

Find device sponsor notification guidance and exemptions, including the separate IVD guidance route.

Review the pharmaceutical establishment and product implementing framework.

Locate the current SFDA-hosted medicinal GMP guide covering manufacturing and quality controls.

Review device establishment, authorization and post-market regulatory provisions.

Locate SFDA device QMS and inspection requirements alongside local regulatory obligations.

Locate adverse-event, complaint investigation and field safety corrective action requirements.

Locate the Health Products Act and Therapeutic Products Regulations 2016 through HSA’s overview.

Find HSA’s adopted medicinal GMP standard and distribution quality expectations.

Locate quality-system dossiers, manufacturer inspection and other therapeutic-product guidance.

Locate the Health Products Act and Medical Devices Regulations 2010 and device licensing pathways.

Find device quality-system, adverse-event and field safety corrective action guidance.

Locate South African pharmaceutical GMP guidance and the latest-version route.

Find device and IVD establishment regulation, licensing and related official resources.

Review expected quality-manual content, including QMS procedures, vigilance and change controls.

Locate MFDS pharmaceutical regulatory publications, including medicinal-product GMP materials.

Locate Korean device, IVD and digital-device GMP rules in a regulator-issued English compilation.

Browse official English medical device regulatory publications and updates.

Locate the Therapeutic Products Act and Medicinal Products Licensing Ordinance, including GMP legal references.

Find inspection procedures and technical interpretations on GMP, quality reviews, audits and release.

Locate MedDO SR 812.213, IvDO SR 812.219 and associated Swiss device legislation.

Find Swiss incident and field safety corrective action guidance for manufacturers and other economic operators.

Review the pharmaceutical statutory framework and its commencement provisions.

Consult pharmaceutical GMP provisions and the mechanism for adopting PIC/S-derived requirements.

Review the dedicated device quality-system framework issued under the Medical Devices Act.

Find device QMS inspection, distribution, licensing and other regulatory references.

Locate Drug Act and implementing regulatory references through the Thai FDA’s medicines legislation directory.

Review facility licensing, overseas GMP clearance, manufacturing standards and drug and biologic registration.

Locate the Medical Devices Act and notifications covering classification, labeling, establishment registration, incidents and field safety corrective actions.

Review the Thai FDA’s overview of manufacturer/importer permissions and risk-based device authorization.

Consult the official legislation record for human medicinal-product manufacturing plants and GMP responsibilities.

Review medicinal-product and API GMP, pharmaceutical quality systems, sterile manufacture, validation, complaints and recalls.

Review the foundational device framework covering manufacturer obligations, conformity assessment, quality systems and post-market oversight.

Review the separate IVD framework and its safety, performance and conformity-assessment requirements.

Find pharmaceutical manufacturing expectations, inspections and supporting GMP/GDP references.

Support reporting, investigating and recalling suspected defective human medicines.

Review the distinct device rules for Great Britain and Northern Ireland, conformity routes and registration.

Find incident reporting, field safety corrective action and post-market surveillance guidance.

Find drug CGMP requirements, including 21 CFR Parts 210, 211, 212 and 600, and related reporting resources.

Support scientifically sound laboratory investigations and assessment of OOS pharmaceutical test results.

Review data governance and reliable records expectations for drug and biologic manufacturing.

Locate CBER deviation reporting requirements and the separate route for CDER-regulated biologics.

Access the FDA device quality-system framework incorporating ISO 13485:2016 and additional FDA provisions.

Assess manufacturer adverse-event reporting and recordkeeping under 21 CFR Part 803.

Find device recall, correction, removal and reporting resources for Parts 7, 806 and 810.

Access the decree detailing implementation of the Pharmacy Law.

Find GMP requirements and attached WHO, PIC/S and EU GMP references for medicines and medicinal ingredients.

Access the foundational medical-device management decree; read with the amendments below.

Review amendments to the medical-device management framework in Decree 98/2021.

Review further amendments to Decree 98/2021, including time-limited transitional provisions.

Find device regulatory notices, consolidated documents and current implementation updates.