MDA has issued a new guidance document on notification of medical device for special access. Earlier in January 2019, a draft for this guidance document was issued and based on public comments and suggestion, some changes have been made in the official release document. With this, Qualtech hereby lists out the changes made in the official guidance document to take note of.
New additions in the official guidance document:
i) Addition of special notes to /section 4 Requirement/:
1)The applicant is responsible to confirm that the products are medical devices. Such products which do not meet the medical device definition are not eligible for this requirement.
2)The applicants who require confirmation if their product is a medical device may refer to guidance document MDA/GD/0006 Definition of Medical Device or submit the ‘Product Classification application form’ to classification@mda.gov.my to determine the classification of the products. The guidance document and form are available to be downloaded at MDA website [www.mda.gov.my](https://www.mda.gov.my) .
ii) Addition of clarification on the eligibility criteria for “Alleviation of stock-out situation” in /section 4.1 Eligibility for special access medical device and notification route/:
For this purpose, consideration will only be given for circumstances such as on-going change notification process and post market actions are being undertaken.
iii) Additional information required for /Notification Form Particulars for Route A/:
a) Supporting documents to be submitted along with:
* List of configurations of the medical device (for grouped devices), if applicable.
* Brochure, catalogue, label, sample of device, if applicable.
* Sterilization validation report for medical device supplied sterile, and relevant sterilization test reports, if applicable.
* Approval certificates from other countries / notified bodies, if applicable.
b) Section D: Clinical Judgement/Public Health Emergency Outbreak of /Notification Form Particulars for Route A:/
* In case of an individual patient, prescribes the patient conditions, and emergency treatment requiring the device.
* In case of public health emergency, prescribe the outbreak requiring the device
c) Section E: Medical Device Safety Information of /Notification Form Particulars for Route A:/
* Batch release - For batch release please provide the number of the devices for one month. i.e. outbreak situation
d) Section G: Attestations & Declaration of /Notification Form Particulars for Route A/:
Criteria for person responsible:
a) Shall be from top management;
i) Person responsible shall have the overall control and have the authority to make decision;
ii) Depending on the organizational structure of the establishment, person responsible may include Proprietor, President, Vice President, Director, Chief Executive Officer (CEO), Managing Director, General Manager or Manager
iv) Additional eligibility to take note of in /Notification for Route B/:
a) Route B is applicable for medical device described in items 2 – 4 of Table 1 with approval in any one of the recognized countries (refer to Annex E of the Guidance Document).
v) Additional information required for /Notification Form Particulars for Route B/:
a) New Section A: Applicant /Company Details of /Notification Form Particulars for Route B/
b) Section C: Medical Device Details of /Notification Form Particulars for Route B/:
Add brief description, Marketing Approval Status in other country (-ies)
c) Section D: Medical Rationale of /Notification Form Particulars for Route B/:
- Provide justification and evidence for design and/or operation that is likely to support or enhance the outcomes of the procedure or treatment for the patient.
- Two additional medical rationale:
i) List the registered devices considered and provide a rationale as to why these registered devices would not adequately meet the requirements of the patient.
ii) Summarize the known safety and effectiveness information in respect of the device.
d) Change in name for the payment: Notification fee to become Administrative charge in /Section 5.2 Administrative charge/:
e) Addition of the clause in /Section 7 Labelling of medical device for special access/:
* There shall be an identification for a special access medical device, and a statement that it shall be only used by a medical practitioner for patient under his care.”
f) Addition of two clauses in/Section 8 Duties and responsibilities of applicant/:
* ensure that labelling is sufficient to ensure safety and performance of the medical device; and
* ensure the use and storage of medical device accordance to manufacturer labelling requirements
Removal of information from the draft guidance document:
i) Removal of Section F: Medical Practitioner Undertaking from the /Notification Form Particulars for Route B/
This guidance document provides all the necessary information to take note of while importing an unregistered medical device for special purposes into Malaysia. The eligibility requirements and necessary documentation for submission have been clearly specified for the convenience of industry stakeholders.
References:
Reference:
- Guidance Document on Notification of Medical Device for Special Access
- MALAYSIA: MDA Issued Draft Medical Device Guidance Document Notification of Unregistered Medical Device for Special Access – March, 2019