New Zealand's Therapeutic Products Act 2023 (TPA) is expected to commence via regulations to be made by the New Zealand government. Once in force, it will replace the current WAND voluntary notification system with mandatory conformity assessment requirements for medical devices.

For manufacturers already registered with TGA (Australia), the TPA is expected to include provisions recognising TGA conformity assessment — the trans-Tasman regulatory cooperation model means a TGA listing may provide a streamlined pathway for New Zealand under the new TPA framework.

Monitor both Medsafe (New Zealand) and TGA (Australia) announcements for:

• The TPA commencement date (subject to New Zealand government regulations)
• Transitional arrangements for devices currently notified on WAND
• Recognition provisions for TGA-registered devices under TPA

Verify the current TPA commencement status directly with Medsafe before planning your New Zealand regulatory strategy.

Bangladesh enacted the Medical Device and Cosmetics Act 2023, establishing a dedicated legislative framework for medical device regulation administered by the Directorate General of Drug Administration (DGDA) under the Ministry of Health and Family Welfare. Prior to this Act, medical devices were regulated under the Drugs Act 1940, which was poorly suited to the regulatory complexity of modern medical devices.

Key features of the 2023 framework:

• Mandatory registration: All medical devices above the lowest-risk category require DGDA registration before import or sale in Bangladesh.
• Risk-based classification: Devices are classified into risk tiers broadly aligned with IMDRF/GHTF principles.
• Local Authorised Representative: Foreign manufacturers must appoint a Bangladesh-based entity to hold the DGDA registration.
• Quality system requirements: GMP evidence or equivalent quality system certification required for higher-risk device classes.
• Post-market surveillance: Adverse event reporting and field safety corrective action obligations introduced.

📅 Effective / published: 2023 (subsidiary regulations and implementation timeline pending full commencement)

The 2023 Act represents a significant modernisation of Bangladesh's medical device regulatory landscape. However, subsidiary regulations and full implementation infrastructure are still being developed. Foreign manufacturers planning market entry should monitor DGDA announcements for implementing regulations and commencement orders, and engage a local representative who can track regulatory developments in-country.

ANVISA (Agência Nacional de Vigilância Sanitária) regulates medical devices in Brazil under Resolution RDC 751/2022, which consolidated and updated prior regulations governing medical device Registro (Registration), Notificação (Notification), and Cadastro (Listing). Devices are classified as:

• Class I (lowest risk) → Notification (Notificação) — streamlined process
• Class II → Listing (Cadastro) — reduced documentation
• Class III and IV (highest risk) → Full Registration (Registro) — complete technical dossier, clinical evidence, and GMP audit

Key requirements include:

• Brazilian Importer (Importador/Responsável Técnico): Foreign manufacturers must partner with an ANVISA-registered Brazilian company that holds the product Registration in its name.
• Good Manufacturing Practice (BPF/GMP) Certificate: Issued by ANVISA or recognised equivalent — required for Class III and IV products.
• Portuguese-language labelling and IFU: All labelling must be in Portuguese.
• DATAVISA/Solicita portal: ANVISA's electronic submission system for Registro applications and post-market notifications.

📅 Effective / published: 2022 (RDC 751); ongoing updates via ANVISA RDCs and INs

Brazil requires the Brazilian importer to hold the ANVISA Registro — foreign manufacturers cannot hold it directly. Identify your Brazilian importer early, as their ANVISA registration status and GMP certificate directly affect your market access timeline.

ANVISA is implementing a UDI framework for medical devices in Brazil, aligned with the international IMDRF UDI guidance. The programme requires manufacturers to assign Unique Device Identifiers to applicable devices and submit UDI data to ANVISA's systems.

Implementation is phased — higher-risk device classes (Class III and IV) face earlier mandatory deadlines, with Class I and II to follow. Manufacturers should monitor ANVISA's official publications in the Diário Oficial da União for applicable compliance dates for their device categories.

🔖 Status: phased implementation in progress

Manufacturers exporting to Brazil should work with their Brazilian importer to understand the UDI timeline applicable to their specific product Registration. ANVISA has issued guidance on accepted UDI issuing agencies (GS1, HIBC) and label placement requirements.

Health Canada is implementing mandatory use of the Regulatory Enrolment Process (REP), its electronic submission platform, for medical device applications. REP replaces paper-based and legacy electronic submission methods for device licence applications and amendments.

Mandatory REP timelines are being phased in by submission type. Manufacturers and importers holding or applying for Health Canada medical device licences should confirm the current mandatory REP adoption deadline applicable to their submission category on the Health Canada website.

Key actions:

• Register your organisation in the Health Canada REP portal if not already done.
• Ensure your regulatory team has completed REP training.
• Confirm whether your pending or planned submissions must be filed via REP before the applicable deadline.

Verify the exact deadline for your submission type directly with Health Canada, as timelines are subject to revision.

State Council Order No. 739 — the Medical Device Supervision and Administration Regulations (MDSMAR) — came into force on 1 June 2021, replacing the 2017 version. The NMPA (National Medical Products Administration) implements the regulations, which establish China's comprehensive framework for medical device registration, manufacture, distribution, and post-market surveillance.

Key provisions of Order No. 739:

• Three-tier risk classification: Class I (lowest, filing), Class II (registration with provincial/municipal NMPA), Class III (registration with national NMPA — highest scrutiny).
• Strengthened clinical evidence: Clinical trials or clinical evaluation by literature/equivalent comparison required for Class II and III; exemptions allowed for certain Class II devices on the exemption list.
• China-specific registration (NMPA Marketing Authorisation): Foreign manufacturers must register through an appointed Overseas Agent (境外注册代理人) registered with NMPA.
• Unique Device Identification (UDI): Mandatory for Class III devices, phased to Class II.
• Enhanced post-market surveillance: Annual post-market study reports for Class III; strengthened adverse event reporting obligations.

📅 Effective / published: 1 June 2021

Foreign manufacturers must appoint an Overseas Agent (not merely a distributor) who takes joint regulatory responsibility and is registered with NMPA. Clinical data generated outside China may be accepted subject to NMPA guidelines on overseas clinical data — assess acceptability early in your submission strategy.

China's NMPA is implementing a phased mandatory Unique Device Identification (UDI) programme. Class III devices have completed mandatory UDI implementation; Class II devices are in the phased rollout.

Manufacturers must:

• Assign a UDI-DI and UDI-PI to each device and packaging level.
• Label devices with the UDI in human-readable and machine-readable (GS1 DataMatrix or QR code) format.
• Register UDI data in the NMPA national UDI database (UDID) through the NMPA's electronic submission system.

🔖 Status: Class III — completed; Class II — phased implementation in progress

Manufacturers with Class II devices entering the Chinese market should confirm the applicable UDI compliance deadline for their specific product category. Class I devices are currently excluded from mandatory UDI. Engage your Overseas Agent early to coordinate UDID registration, as the process requires a NMPA account and Chinese-language submissions.

Under the extended IVDR transition provisions, Class B IVDs and Class A sterile IVDs must obtain IVDR conformity assessment by 26 May 2027. Class B IVDs require involvement of a designated IVDR Notified Body for their quality management system; Class A sterile IVDs require NB involvement for sterility aspects.

IVD manufacturers in these classes should already be actively engaged with an IVDR-designated Notified Body. The number of designated IVDR Notified Bodies remains limited — manufacturers without an active NB application should treat this as a critical path item and initiate contact immediately.

Under the extended IVDR transition timetable, Class B, C, and D IVDs requiring full IVDR Notified Body conformity assessment (NB review of technical documentation, not just QMS) must complete IVDR certification by 26 May 2028.

Class C and D IVDs carry the highest scrutiny requirements under IVDR, including performance evaluation with clinical evidence and, for Class D devices, batch release verification by an EU Reference Laboratory (EURL). Manufacturers in these categories should have active NB engagement and performance study programmes well underway before this deadline.

Under Regulation (EU) 2024/1860, Class IIb implantable devices (excluding sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) that hold a valid MDD/AIMD certificate must obtain EU MDR conformity assessment by 31 December 2027 to continue to be placed on the EU market.

Manufacturers relying on legacy MDD/AIMD certificates for Class IIb implantable devices must have a valid EU MDR certificate in place before this date. Engage your Notified Body immediately to confirm your MDR conformity assessment timeline — NBs remain heavily capacity-constrained. Devices without a valid EU MDR certificate after this date cannot be placed on the EU market or put into service.

Under Regulation (EU) 2024/1860, the following device classes must complete EU MDR conformity assessment by 31 December 2028 to continue to be placed on the EU market:

• Class III devices (excluding Class IIb implantables covered by the 2027 deadline)
• Class IIa devices
• Class IIb non-implantable devices
• Class I sterile and Class I measuring devices requiring Notified Body involvement

This is the final end-date for MDD/AIMD certificate-based market access. All devices in these classes must hold a valid EU MDR certificate by this date. Notified Body capacity constraints mean manufacturers should not delay initiating their MDR conformity assessment transition.

Hong Kong's Medical Device Administrative Control System (MDACS), administered by the Medical Device Division (MDD) of the Department of Health, is currently a voluntary scheme for medical device listing. Unlike most major markets, Hong Kong does not currently have mandatory pre-market registration for medical devices — however, devices listed under MDACS demonstrate alignment with international safety and performance standards and are required or preferred for procurement by public hospitals and government healthcare institutions.

MDACS classification follows the risk-based framework:

• Class I (lowest risk) — Self-declaration; no product listing required
• Class II, III, IV (higher risk) — Voluntary product listing; evidence of conformity assessment (CE mark, FDA clearance, TGA registration, or equivalent) required

The Hong Kong government has been consulting on introducing mandatory device registration legislation to replace the voluntary scheme. This reform, if enacted, would align Hong Kong more closely with other major regulatory frameworks.

📅 Effective / published: MDACS operational; mandatory reform under consultation

Manufacturers supplying devices to Hong Kong public hospitals or government healthcare buyers should list applicable devices under MDACS. Monitor the Department of Health and Food and Health Bureau announcements for updates on the proposed mandatory registration legislation, which could significantly change market access requirements.

Hong Kong's Food and Health Bureau and Medical Device Division (MDD) have been developing a legislative framework to make medical device registration mandatory. Under the proposed framework, Class II, III, and IV devices would require registration with the MDD before they may be imported or supplied in Hong Kong — replacing the current voluntary MDACS listing scheme.

The reform aims to align Hong Kong with international regulatory standards and strengthen patient safety protections. Devices already listed under MDACS with conformity assessment evidence from recognised bodies (CE, FDA, TGA, etc.) would be well-positioned to transition to mandatory registration when required.

🔖 Status: under development / consultation

Manufacturers currently supplying devices in Hong Kong under the voluntary MDACS scheme should participate in any public consultations on the mandatory registration legislation and begin preparing their conformity assessment documentation now. Devices with valid CE marks, FDA clearances, or other internationally recognised approvals will likely have a streamlined pathway under the mandatory scheme.

India's Medical Devices Rules 2017 (MDR 2017), notified under the Drugs and Cosmetics Act 1940, introduced a comprehensive risk-based regulatory framework for medical devices administered by the Central Drugs Standard Control Organisation (CDSCO). Devices are classified as Class A (lowest risk), B, C, or D (highest risk), broadly aligned with the IMDRF/GHTF classification principles.

Key features:

• Import Licence (Form MD-14) required for all Class B, C, D imported medical devices before sale in India.
• Class A import requires a simplified process (Form MD-15/notification) rather than a full licence.
• Indian Authorised Representative (IAR): Foreign manufacturers must appoint an IAR registered with CDSCO who holds the import licence.
• Free Sale Certificate (FSC) and Certificate of Conformity (CoC) from the country of origin required for import applications.
• SUGAM portal: CDSCO's online platform for all medical device applications, status tracking, and communications.
• Manufacturing licence: Issued by State Licensing Authorities (SLAs) against GMP requirements in Schedule 5 of MDR 2017.

📅 Effective / published: 2017; phased implementation (notified device categories expanded in stages through 2023+)

India has significantly expanded the list of notified medical devices requiring registration under MDR 2017. Manufacturers should verify whether their specific device category has been brought under regulatory control and whether transitional timelines apply. CDSCO frequently updates the notified device lists — check the SUGAM portal for the current schedule.

India's MDR 2017 framework uses a phased notification approach — medical device categories are progressively brought under mandatory CDSCO regulation by Gazette notification. Devices not yet notified can be imported and sold without a licence (subject to other applicable laws), but once a category is notified, the MDR 2017 registration requirements apply.

Manufacturers supplying India must:

• Confirm whether their specific device category is currently on the notified list (Schedules to MDR 2017 and subsequent amendment notifications).
• If recently notified, comply within the applicable transition period specified in the notification.
• If not yet notified, monitor the CDSCO website and Gazette of India for upcoming notifications affecting your device category.

The CDSCO and Ministry of Health and Family Welfare issue updated device category notifications periodically. Verify the current notification status of your device category directly with CDSCO or your Indian Authorised Representative (IAR).

CDSCO is rolling out India's Unique Device Identification (UDI) framework, aligned with the IMDRF UDI guidance. Under the framework, manufacturers are required to:

• Assign a UDI-DI (Device Identifier) and UDI-PI (Production Identifier) to each device and its packaging.
• Label devices with the UDI in human-readable and machine-readable format.
• Submit device information to the UDID (Unique Device Identification Database) maintained by CDSCO through the SUGAM portal.

🔖 Status: phased implementation; higher-risk device classes first

Manufacturers supplying devices in India should monitor CDSCO announcements for the applicable UDI implementation timeline for their device class. Early engagement with your IAR to coordinate SUGAM account setup and UDID submissions is recommended, as the portal requires Indian business credentials.

In Indonesia, medical devices are regulated by the National Agency of Drug and Food Control (BPOM — Badan Pengawas Obat dan Makanan). All medical devices must obtain a Distribution Permit (Izin Edar / IE) before they may be lawfully sold or distributed in Indonesia. The regulatory framework is implemented under Ministry of Health (Permenkes) regulations and aligns with the ASEAN AMDD classification scheme (Class A, B, C, D).

Key requirements:

• Indonesian Local Representative (AKMD): Foreign manufacturers must appoint an Indonesian company or individual registered with BPOM as the local representative responsible for the IE application.
• Distribution Permit (Izin Edar): Required for Class B, C, and D devices; Class A devices may follow a streamlined notification process.
• Quality system evidence: ISO 13485 certificate or equivalent GMP evidence is typically required for Class B–D.
• Post-market surveillance: Mandatory adverse event reporting, field safety corrective action coordination, and periodic post-market studies.

📅 Effective / published: Ongoing regulatory framework; updates issued via Permenkes regulations

Foreign manufacturers must not sell directly to Indonesian buyers without a registered AKMD. The AKMD holds the IE and is jointly responsible with the manufacturer for product safety and regulatory compliance. Ensure all labelling includes Indonesian-language content as required.

Foreign manufacturers must hold a valid Foreign Manufacturer Accreditation (FMA) issued by PMDA to export medical devices to Japan. FMA certificates are valid for 5 years from the date of issue, and renewal must be completed before expiry — there is no grace period, and an expired FMA invalidates the ability to export to Japan.

Key actions for FMA renewal:

• Identify your FMA expiry date from your current certificate.
• Initiate the renewal application with PMDA (via your Japan-based MAH) at least 6 months before expiry to allow for review time.
• Ensure your quality management system documentation (ISO 13485 or QMS Ordinance equivalent) is current and available for PMDA review.
• Confirm that your Japan MAH (Marketing Authorisation Holder) is prepared to submit the renewal on your behalf.

FMA renewal timelines can vary — do not rely on PMDA reminders. Set an internal alert based on your certificate expiry date.

Malaysia's Medical Device Authority (MDA) is implementing a Single Licence Policy that streamlines establishment licensing by consolidating what were previously separate licences for different activities into a single establishment licence covering all relevant device-related activities.

Affected establishments include importers, distributors, and manufacturers. The policy is intended to reduce administrative burden while maintaining regulatory oversight.

Key actions:

• Confirm with MDA or your Malaysia-based regulatory representative whether your current establishment licence is affected by the Single Licence Policy.
• If a new application or amendment is required, initiate it well in advance of the implementation deadline.
• Check MDA's official FAQ and guidance on the Single Licence Policy for the specific timeline applicable to your establishment type.

Verify the current implementation date and requirements directly with MDA, as timelines may have been updated since initial announcements.

COFEPRIS introduced an abbreviated registration pathway for medical devices that already hold marketing authorisation from a recognised reference regulatory authority — including the FDA (510(k)/PMA), CE mark under EU MDR/IVDR, Health Canada, TGA (Australia), or ANVISA (Brazil). Eligible devices can leverage the reference approval as the primary basis for their Mexican Sanitary Registration (Registro Sanitario), substantially reducing technical documentation requirements and review timelines.

🔖 Status: in-force

Manufacturers with existing approvals from reference countries should assess whether the abbreviated route is available for their Mexican submission. Key eligibility factors include device class, the specific reference authority, and whether the device is already legally marketed in the reference market. The abbreviated pathway does not eliminate all local requirements — Spanish labelling (per NOM-137-SSA1-2025), local representative obligations, and post-market commitments remain in force. Consult your regulatory affairs team or a Mexico-based RA specialist to confirm eligibility before selecting this route.