Ministry of Health
Ministry of Health
Regulatory Authority
National Medicines Regulatory Authority (NMRA)
Medical Device Regulation
National Medicines Regulatory Authority Act No. 05 of 2015
Official Language
Sinhala, Tamil
Classification
Class I, IIa, IIb and III
Registration Process
Documents Required
Legalised/Notarised Documents (if any)
Free Sales Certificate
Post-market Requirements
The serious adverse events should be reported within 24 hours. Any suspected AE should be reported as soon as possible.
Applicable QMS
ISO 13485
Authorized Representative
Yes. Marketing Authorization Holder
License Validity
Special Notes
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
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