Regulatory Authority | The Drug Regulatory Authority |
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Regulatory Authority Website Link | Click Here |
Device Classification | A,B,C,D |
Medical Device Regulations | Guideline for Registration of Medical Devices (Same Regulations for IVD) | Click Here |
IVD Classification | A,B,C,D |
In Vitro Diagnostics Regulations | https://drive.google.com/file/d/10MUMl8MXVYDW9AEdrk8duw0CtbzAyalG/view |
Device Classification Guidelines |
Refer to Section 11.5: Risk classification rules | Click Here |
Registration Process | Section A and B of Guideline for Registration of Medical Devices | Click Here |
Registration Timeline | 2 to 3 months |
Technical Documentation Format |
For class B, C and D products applied through the full route of registration, the following are the required information: b. Relevant Essential Principles and Method Used to Demonstrate Conformity c. Essential Principles and Evidence of Conformity d. Device Description e. Performance Data/ Report or Certificate of Analysis f. Clinical Evidence g. Device Labeling h. Risk Analysis |
Requirement of Authorized Representative | Yes |
Language Requirement | Labels provided must be in English. |
Labeling Requirements |
This is the descriptive and informational product literature that accompanies the device any time while it is held for sale or shipped. This section should summarize or reference or contain the following labelling data to the extent appropriate to the complexity and risk class of the device, which is generally considered as “labelling”: The labels on the medical device and its packaging are to be provided for the primary and secondary levels of packaging and shall be provided in the original colour. Labels must be provided for all the components of a medical device system, members of a medical device family and accessories submitted for registration |
Declaration of Conformity |
The manufacturer should attest that its medical device complies fully with all applicable Essential Principles for Safety and Performance as documented in a written Declaration of Conformity (DOC). At a |
Certificate of Free Sale |
A confirmatory letter issued by the Competent National Regulatory Authority, which indicates the name(s) of the device(s) (with model if applicable) and explains whether the products are freely sold in the country of origin should be provided; if not, the reasons thereof should be clearly stated with appropriate justification. |
Recalls |
Recalls occur at wholesale, retail, or consumer levels depending on risk and distribution, with timelines of 24-72 hours for Class I, 10 working days for Class II, and 30 working days for Class III. Companies must notify the Drug Regulatory Authority (DRA) 24 hours prior to a recall, and the DRA then notifies stakeholders, conducts inspections, and may issue press releases. | Click Here |
Additional Information | Validity of renewal certificate shall be for 3 years from the date of re-registration. |