Medical Device Registration in India

Regulatory Requirements for SE Asian Countries

CountryApproval BodyDetails
IndiaCentral Drug Standards and Control Organization (CDSCO)An Indian Authorized Agent has to be appointed by the manufacturer for the registration process.Medical Device classification Medical devices are not classified in India.Time Frames 6-9 months for all medical devices.Additional Information A detailed technical dossier is required the registration process in India. Manufacturers who have got a home approval (FDA or CE) can use them to leverage their device registrations in India. The Registration certificate is valid for a period of 3 years and need to be re-applied within 6-9 months prior to its expiry date.
ChinaChina Food and Drug Administration (CFDA)Management of registrations and after sales services will be managed by a legal agent who has to be appointed.Medical Device classification Class I, Class II, Class IIITime Frames 11-12 months for Class I device, 17-30 months for Class II device and 17-36 months for Class III devices.Additional Information Clinical trials are required for Class III devices and those that do not have the approval in any other countries. Before submitting the dossier, it is necessary to present the device for testing which would be carried out by the CFDA. The CFDA reviews the documents and grants the IMDRC certificate, which is valid for a period of 4 years, and re-registration can be done within 6 months of the expiry.
Hong KongMedical Device Control Office (MDCO)Medical Device Classification Class I, Class II, Class III and Class IVTime Frames 12-14 months for all classesAdditional Information No specific regulations. Voluntary guidelines are in place currently. Documentation requirement is similar to GHTF guidelines.
IndonesiaNational Drug and Food Control (NA-DFC)NA-DFC is the regulatory body in Indonesia. The agency also oversees the licensing and certification of pharmaceuticals and medical devices. Under the NA-DFC, the Deputy of Therapeutic Products and Narcotics, Psychotropic and Addictive Substance Control is the sector responsible for pre-market evaluations of drugs and devices, including inspections of manufacturing sites to ensure Good Manufacturing Practice (GMP), and post-market surveillance activities once products have been licensed. These include product sampling, laboratory testing, and inspections of manufacturing and distribution facilities. This sector is supported by several other departments.
JapanPharmaceuticals and Medical Devices Agency (PMDA)Marketing Authorization Holder must be appointed for all device classes.Medical Device Classification Class I, Class II, Class III, Class IVTime Frame 1-5 months for Class 1-II, 8-18 months for Class III- IVAdditional Information Submission of a Foreign Manufacturer Accreditation (FMA) for the manufacturing facilities, which ensures that the ISO certificate complies with the Japanese regulations. A pre-market application is required for all submissions. For Class II a QMS audit is required and for Class III-IV, additional onsite audits are required. The certificates issued by the MHLW do not expire.
KoreaKorea Food and Drug Administration (KFDA)A registered office in Korea or a Korean License Holder to liaison with the MFDS must be appointed in Korea.Medical Device Classification Class I, Class II, Class III and Class IVTime Frame 2-6 months for Class I, 12-16 months for Class II, Class III and Class IVAdditional Information For Class I a basic KGMP certificate can be obtained. In case your device falls under Class 1 (specially controlled), Class II, Class III or Class IV, a detailed technical dossier along with a sample device for testing must be submitted to the MFDS.
MalaysiaMedical Device AuthorityMedical device registrations are not mandatory in Malaysia and are thus more on a voluntary basis currently.
PhilippinesBureau of Food and Drugs (BFAD)Bureau of Food and Drugs (BFAD), currently called as Food and Drug Administration is the medical device approving body in Philippines. Regulators in the Philippines are currently developing more substantive requirements for medical devices; for now, only specific devices are subject to mandatory registration.
SingaporeHealth Sciences Authority (HSA)Medical Device Classification Class A, Class B, Class C, Class D.Time Frames 1 month for Class A, 1-4 months for Class B and 7-13 months for Class C and D.Additional Information The regulations are very simple and easy for the West and almost 90 % of the paper work is identical to EU documentation process, which makes it easier for the medical device manufacturers.
TaiwanTaiwan Food and Drug Administration (TFDA)Medical Device Classification Class A, Class B, Class C and Class DTime Frames 1 month for Class A devices, 12-17 months for Class B and C devices and 14-24 months for Class D devices.Additional Information The classification of medical devices is similar to US. Class II and III devices should have home country approvals, QSD certifications and pre-market approvals prior to TFDA.
VietnamDrug Administration of Vietnam (DAV)Medical devices that are on a restricted list must be registered with the Department of Medical Equipment and Health Works (DMEHW) of DAV.Additional InformationIn addition, the Ministry of Science and Technology (MOST) performs some regulatory functions relevant for domestically made medical devices. IVDs are regulated as drugs in Vietnam only if they contain biological substances. Otherwise, they are regulated as medical devices.
  • Registration and Approval for Medical Devices, IVDs and Pharmaceutical
  • Reimbursement
  • Local Representation
  • Quality Systems
  • Regulatory Compliance
  • Labeling
  • Clinical Trials
  • Language Translation

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