Refer to Section 11.5: Risk classification rules

For class B, C and D products applied through the full route of registration, the following are the required information:
a. Executive Summary

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

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”:
i. Labels on the device and its packaging;
ii. Instructions for use;
iii. Physician‟s manual
iv. Any information and instructions given to the patient, including instructions for any procedure the patient is expected to perform (if applicable).

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

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
minimum, this declaration should contain the following information:
a. statement that each device is the subject of the declaration
b. complies with the applicable Essential Principles for Safety and Performance( for class C and D only),
c. has been classified according to the classification rules set by the GHTF, and,
d. has met all the applicable conformity assessment elements;
e. a Global Medical Device code and term for the device(s) if applicable;
f. description of Conformity assessment procedure;
g. date from which the Declaration of Conformity is valid;
h. name and address of the device manufacturer; and,
i. the name, position, and signature of the responsible person who has been authorized to complete the Declaration of Conformity on behalf of the manufacturer

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 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.

Validity of renewal certificate shall be for 3 years from the date of re-registration.