For a successful international approval, medical device manufacturers should familiarize themselves early with regulatory requirements and country-specific peculiarities.So, don't let valuable time pass, but talk to our experts in regulatory affairs in a timely manner. We ensure that your product is approved in the target country at the intended time.Contact us now to schedule a no-obligation initial consultation and put our expertise to the test. We look forward to meeting you!
Different countries, different customs – that is all the more true in the context of certification and market entry. Use our know-how, stay on the safe side!
Our international approval services in detail:
- Supporting the creation of registration documents for the approval of medical devices with the authorities in various countries (USA (FDA), Australia (TGA), Canada (HC), China (NMPA), Japan (PMDA)) in accordance with legal requirements,
- Preparing approval applications for international registration procedures,
- Accompanying the approval process, planning and preparing change and renewal requests,
- Communication with regulatory authorities,
- Researching specific regulatory requirements for defined target countries (e.g. UDI, classifications, labeling, re-registrations, etc.).
Regulatory requirements and approval pathways worldwide
How does FDA approval for medical devices work in the United States?
Regulatory Framework
Medical devices are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).Local Representative
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.Manufacturer Obligations
Manufacturers involved in production and distribution must complete an annual Establishment Registration and list their products in the Device Listing database (FURLS).Quality System Requirements
A quality management system aligned with the Quality Management System Regulation (21 CFR Part 820), also called cGMP requirements, is mandatory. ISO 13485 is referenced since 2024.Recognition of other Registrations
The CE mark is not accepted; a specific FDA procedure is required.Approval Routes
Based on product risk and classification:
- 510(k) Notification Premarket Notification (predicate device existing)
- De Novo Request
- Premarket Approval (PMA)
Includes mandatory reporting, recalls, change notifications and regular updates to FDA listings.Your path to FDA approval:
We support you in selecting and executing the right submission route, help prepare technical documentation and support your FDA-compliant QMS, and aligning your registration strategy with your U.S. partner.
What are the key steps for medical device approval in Japan?
Regulatory Framework
The Pharmaceuticals and Medical Devices Agency (PMDA) as part of the Ministry of Health, Labour and Welfare (MHLW) oversees medical devices under the Pharmaceutical and Medical Device Act (PMD Act).Local Representative
A Japan-based (Designated) Marketing Authorization Holder (MAH/DMAH) must be appointed. Foreign manufacturers must register their site („Foreign Manufacturer Registration FRM“). Quality System Requirements
Japan requires ISO 13485 compliance, with additional local provisions (Ministerial Ordinance #169). Participating in the MDSAP Program.Recognition of other Registrations
Existing certifications may support the process but are not sufficient for approval. Approval Routes
Depending on the four different risk classes:
- Todokede (Class I), Pre-market Notification
- Ninsho (Class II, III with certification standard CS), Pre-market certification
- Shonin (Class II, III without CS & class IV)
Special requirements for product labelling. Regular reports, information about product changes, surveillance activities, and vigilance obligations apply.Japan strategy with Metecon:
We help you with product classification according to JMDN, to select a suitable MAH/DMAH, prepare the required documentation, and guide you through the PMDA approval process as well as the communication with the MAH/DMAH.
What is the medical device approval process with ANVISA in Brazil?
Regulatory Framework
Agência Nacional de Vigilância Sanitária (ANVISA) regulates medical devices based Law 6360/1976. Further resolutions were passed with the most relevant being RDC 751/2022.Local Representative
Foreign manufacturers must appoint a Brazilian legal representative (Brazil Registration Holder). The manufacturer of higher class products also needs to obtain the GMP-certificate from ANVISA.Quality System Requirements
ISO 13485 is recognized; MDSAP certification significantly facilitates the process.Recognition of other Registrations
Such certificates support the application process, but are not accepted as replacements.Approval Routes
Depending on classification:
- Notification "notificação" (class I, II) or
- registration "registro" (class III, IV) (II, IV) procedure.
Manufacturers must ensure regular updates, vigilance reporting, and, if needed, product recalls. Special requirements for product labelling.Your access to the Brazilian market:
We coordinate with your local representative, prepare ANVISA-compliant documentation, and support you throughout the registration process.
What does Health Canada require for medical devices?
Regulatory Framework
Health Canada regulates medical devices under the Medical Devices Regulations MDR (SOR/98-282).Local Representative
Foreign manufacturers do not need a local representative in Canada.Manufacturer Obligations
- Establishment License (MDEL) for distributors/importers and manufacturers of class I products
- Medical Device License (MDL) for Class II–IV products
A valid MDSAP certificate is mandatory for Class II–IV MDs.Recognition of other Registrations
CE-mark and FDA approval are not accepted for registration purposes.Approval Routes/MDL
An application has to be submitted to Health Canada based on the class of the MD. Review of the Application and for higher classes submitted technical documentation by Health Canada.Post-Market Requirements
Include adverse event reporting, recalls vigilance and documentation maintenance. Changes have to be reported.Planning market entry in Canada?
We ensure a smooth licensing process with Health Canada – from MDSAP alignment to full MDL submission.
How do you register your medical device with the TGA in Australia?
Regulatory Framework
The Therapeutic Goods Administration (TGA) governs device approval under the Therapeutic Goods Act 1989 and further informed by Therapeutic Goods (Medical Devices) Regulations 2002.Local Representative
Only an Australia-based sponsor can list your product in the Australian Register of Therapeutic Goods (ARTG).Quality System Requirements
ISO 13485 is required; MDSAP certification is accepted and often preferred.Recognition of other Registrations
TGA accepts abridgement of conformity assessments based on marketing authorizations from "comparable overseas regulators" (mainly MDSAP countries) for classes I-III. May support applications but do not replace TGA requirements.Approval Routes
Based on risk class (I-III): includes review of technical documentation and existing certificates by TGA.
Class I medical device can be included in the ARTG via a self-declaration process.
Higher class medical device manufacturers need a conformity assessment by TGA or comparable overseas regulator. Post-Market Requirements
Vigilance, recall management, document updates, post-market surveillance and sponsor coordinationReady for Australia?
We support ARTG submissions, review your previous certifications, and coordinate the selection and communication with a suitable Australian sponsor partner.
How does the MFDS approval process work in South Korea?
Regulatory Framework
The Ministry of Food and Drug Safety (MFDS) regulates medical devices under the Medical Device Act (MDA).Local Representative
Foreign companies must designate a Korea-based license holder KLH. The manufacturer itself needs a business license by MFDS.Quality System Requirements
Devices must comply with the Korea Good Manufacturing Practice (KGMP), aligned with ISO 13485.Recognition of other Registrations
CE or FDA may support the review but are not sufficient for approval.Approval Routes
Lower-risk MDs (Class I): simple electronic listing process and submission of documents (Notification MDITAC)
Medium-risk MDs: (Class II): Certification by MDITAC
Higher-risk MDs (Class II-IV): Full approval procedure by MFDS with TD Review Post-Market Requirements
Recall and vigilance procedures, periodic updates of registration data, post-market surveillance..Entering the Korean market?
We assist with KGMP readiness, documentation, and liaison with your Korean partner.
What should you know about submitting your medical device via the SUGAM portal in India?
Regulatory Framework
The Central Drugs Standard Control Organization (CDSCO) governs devices under the Drugs & Cosmetics Act, 1940 and the Medical Devices Rules, 2017.Local Representative
Non-Indian manufacturers must appoint a local representative.Quality System Requirements
ISO 13485 is required. In some cases additional requirements such as auditing also apply.Recognition of other Registrations
Not sufficient for registration but may be included in the documentation.Approval Routes
Conducted via the SUGAM Portal, including submission of technical documentation. Different forms are used in the approval process based on risk classes A-D. In general manufacturing and import licenses are required.Post-Market Requirements
Vigilance reporting, data maintenance, and recall procedures are mandatory.Compliant entry into India with Metecon:
We support your online submission via the SUGAM Portal, help identify a reliable representative, and ensure documentation compliance.
What is required to access the Saudi Arabian medical device market?
Regulatory Framework
The Saudi Food and Drug Authority (SFDA) regulates devices under the Royal Decree No. (M/54).Local Representative
A local Saudi Authorized Representative is required for all foreign manufacturers and is the interface with the SFDA.Quality System Requirements
ISO 13485 is required. The SFDA may request additional proof of conformity. International certificates (e.g. CE, MDSAP) must be reviewed by SFDA.Approval Routes
All MDs must obtain Medical Device Marketing Authorization (MDMA), There are exceptions for devices that are considered safe and effective. MDMA Applications must follow the Technical File Assessment (TFA) registration route and submit registration documentation through the SFDA GHAD online portal. Post-Market Requirements
Payment of annual fees, Manufacturers must keep records updated, report incidents, have recall procedures and comply with post-market surveillance requirements. In addition, there are requirements for Unique Device Identification (UDI).Expanding to Saudi Arabia?
We guide you through the GHAD system, TFA procedures/MDMA submissions, and all relevant SFDA conformity assessments and creation of country-specific documentation.
