MD around the world
MD registrations around the world
Canada (Health Canada)
A Medical Device Licence (MDL) is the authorization issued by Health Canada that allows Class II, III and IV medical devices to be marketed in Canada.
Manufacturers must submit technical documentation demonstrating that the device meets Canadian safety, effectiveness and quality requirements before obtaining an MDL.
Can Maytal support my Health Canada registration?
Yes. Maytal provides complete support for Canadian registrations, including regulatory strategy, device classification, preparation of the submission dossier, communication with Health Canada and support until the Medical Device Licence is granted.
An MDEL is a licence required for companies that import or distribute medical devices in Canada.
Unlike the MDL, which applies to medical devices, the MDEL applies to establishments involved in commercial distribution.
Maytal can advise manufacturers and distributors on whether an MDEL is required for their business activities.
Foreign manufacturers typically require a Canadian importer or distributor to commercialise their products effectively.
The importer may have regulatory obligations depending on the commercial model adopted.
Maytal can support manufacturers in identifying the most appropriate market access strategy for Canada.
Yes. Manufacturers of Class II, III and IV medical devices must hold a valid MDSAP certificate before obtaining a Medical Device Licence.
Maytal supports companies with MDSAP readiness assessments, quality system implementation and audit preparation.
Brazil (ANVISA)
Medical devices must be authorised by ANVISA (Agência Nacional de Vigilância Sanitária) before being placed on the Brazilian market.
Depending on the device classification, the regulatory pathway may involve either Cadastro or Registro.
Maytal manages the complete ANVISA registration process.
Foreign manufacturers cannot register medical devices directly with ANVISA.
A Brazilian Registration Holder (BRH) is required to submit and maintain the registration on behalf of the foreign manufacturer.
The BRH is responsible for regulatory communications with ANVISA and maintaining the licence.
Can Maytal provide BRH services?
Yes. Through our trusted local partners, Maytal can provide fully compliant Brazilian Registration Holder services.
Lower-risk medical devices generally follow the Cadastro pathway, while higher-risk devices require a Registro, which involves a more comprehensive technical assessment by ANVISA.
Maytal evaluates the appropriate regulatory pathway before initiating the registration process.
Yes. ANVISA recognises MDSAP certification for many regulatory activities, significantly reducing the need for separate GMP inspections.
Maytal helps manufacturers leverage existing MDSAP certification to accelerate Brazilian market access.
Japan (PMDA / MHLW)
Medical devices marketed in Japan must comply with the requirements of the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW).
Depending on the device classification, different approval pathways apply.
Maytal supports the complete Japanese registration process.
Foreign manufacturers must appoint a Japanese Marketing Authorization Holder (MAH) before marketing medical devices in Japan.
The MAH is responsible for regulatory submissions and maintaining product approvals.
Can Maytal provide MAH services?
Yes. Through our Japanese partners, Maytal provides complete MAH support for overseas manufacturers.
A Designated Marketing Authorization Holder (D-MAH) acts on behalf of a foreign manufacturer without taking ownership of the registration.
Many overseas manufacturers prefer the D-MAH model because it provides greater commercial flexibility.
Maytal can advise on the most suitable MAH structure for your business.
Japan offers several regulatory pathways, including Todokede, Ninsho, and Shonin, depending on device classification and applicable certification standards.
Maytal determines the correct regulatory pathway before initiating registration.
South Korea (MFDS)
Medical devices must obtain approval from the Ministry of Food and Drug Safety (MFDS) before being commercialised in South Korea.
The applicable registration pathway depends on the device classification and supporting technical documentation.
Maytal provides complete MFDS registration support through experienced Korean regulatory partners.
Foreign manufacturers generally require a Korean Licence Holder to submit and maintain medical device registrations in South Korea.
The Licence Holder acts as the regulatory representative before MFDS.
Can Maytal provide Korean Licence Holder services?
Yes. Through our trusted Korean partners, Maytal can provide fully compliant Korean Licence Holder services.
Korea Good Manufacturing Practice (KGMP) is the Korean quality system requirement applicable to many medical devices marketed in South Korea.
Maytal supports manufacturers preparing for KGMP assessments and regulatory compliance.
Registration timelines vary depending on the device classification, documentation quality and testing requirements.
Maytal performs an initial regulatory assessment to estimate realistic project timelines before submission.
Singapore (HSA)
Medical devices must be registered with the Health Sciences Authority (HSA) before being supplied in Singapore unless exempt under specific regulations.
Registration requirements depend on the device risk classification and previous approvals in recognised reference markets.
Maytal supports complete HSA registration projects through experienced Singapore-based regulatory partners.
Yes. Foreign manufacturers cannot register medical devices directly with HSA and must appoint a Singapore-based Registrant responsible for maintaining the product registration.
Can Maytal provide Registrant services?
Yes. Through our local partner network, Maytal provides compliant Singapore Registrant services.
The ASEAN CSDT is the harmonised technical documentation format used by Singapore and several ASEAN countries.
Preparing documentation according to CSDT requirements can significantly facilitate future registrations across Southeast Asia.
Maytal develops technical documentation that supports broader ASEAN market access strategies whenever possible.
Yes. One of Maytal's core strengths is coordinating global regulatory projects through a single point of contact. We support manufacturers with international registration strategies covering Europe, the United Kingdom, the United States, Canada, Brazil, Japan, South Korea, Singapore, Australia, the Middle East and many other markets.
Our objective is to maximise the reuse of technical documentation, reduce regulatory costs and accelerate worldwide market access.