Malaysia, guidance document for the pre-submission meeting.

Malaysia, guidance document for the pre-submission meeting.

On 13th February 2020, the Guidance Document for Pre-Submission Meeting (PSM) was unveiled.

PSM a new service provided by the Nationalized Regulatory Division of Pharmacy. A platform intended for product registration holders to ask questions and seek clarification on product quality, safety and efficacy during the product development stage.

Their current focus is on 4 product categories:

1.      New drug products;
2.      Biologic products (including biosimilar products);
3.      Natural products with therapeutic demands;
4.      Health supplement products with the risk of disease reduction.

Issues related to the application for a manufacturer license or Good Manufacturing Practice (GMP) certification are not covered by the scope of the PSM.

For the start of this new implementation, the total number of meetings will be limited to 1 session per month, a maximum of 2 PSM sessions per product.

Product registration holders interested in getting PSM services can do so by followings the below-mentioned steps:

1.      Complete the PSM request form from www.npra.gov.my.

2.      Make sure you are a locally incorporated company, corporate or legal entity, with a permanent address and registered with Companies Commission of Malaysia.

3.      Ensure PSM request form is emailed at least 8 weeks in advance before the proposed meeting
date to presubmission@npra.gov.my.

4.      NPRA will then review and screen the applications.

·        If approved, applicants will be notified with the confirmation.
·        If not approved, applicants will also be notified and introduced to other alternatives.

Refer to the procedure (Via the link) in the Guidance Document for Pre-Submission Meeting (PSM) guidelines for more information.
https://bit.ly/3aonJ67

The services offered are non-mandatory. However, any advice provided by NPRA during the PSM is non-binding, taking into account the regulatory developments that may change from time to time.

The implementation of this new implementation would officially be on 15th March 2020.

New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia

New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia

Coming into effect on the 1st of July 2020.

Duties and obligations of this regulation are categorized into 6 categories.

  1. Distribution records

Contents required for a distribution record, implantable medical device distribution record and the period of maintenance required.

  1. Records of complaint handling

Complaint handling procedures and requirements for a record of complaint handling and the holding of a complaint record.

  1. Mandatory problem reporting

This involves submitting the investigation report to the Authority which must be done within 30 days.

  1. Field corrective or preventive action

This states that establishments shall notify the Authority before any field corrective or preventive action is being done.

  1. Voluntary recall

This involves the voluntary recall within the time frames as follows,

 Class I (High risk)

No less than 48 hours before the recall is made.

 Class II (Medium risk)

No less than 3 days before the recall is made.

 Class III (Low risk)

No less than 5 days before the recall is made.

  1. Mandatory recall

The Authority may order a recall of any medical device at any time for reasons of patient safety and public health.

Malaysia, Medical Devices advertising

As of Medical Device (Advertising) Regulations, no advertisement of any registered medical device can be done without the approval from the Ministry of Health Malaysia.

In order to make an advertisement an application for an approval to advertise a registered medical device must be submitted to the Ministry of Health Malaysia in writing accompanied by specific documents.

This regulation will come into full effect starting from 1st July 2020.

Anyone found guilty of breaching this regulation shall be liable to a fine not exceeding RM 200,000 or imprisonment for a term not exceeding 2 years or to both.

To facilitate a smooth process for an approval to advertise a registered medical device.

The following documents and steps are required,

  • Copy of advertisement plan of the medical device.
  • Processing fee of RM 1,000.
  • Letter of appointment from the origin of the medical device which it was registered.

Alongside the following 2 pointers to be included in the advertisement.

  • A certificate that the medical device is registered under the Act.
  • Registration number assigned to the registered medical device by the Authorities.

Malaysia’s guideline for registration of combination products

Malaysia has fully implemented on 1st July 2019, the guidelines for registration of drug-medical device and medical device-drug combination products.

Medical devices with substances incorporated when used on their own could be considered as a medical product, must adhere to this regulation.

Falling under Class D, Rule 13 of the Medical Device Regulation 2012. A medical device-drug combination product registration requires a 3 stage process:

Stage 1 – Obtaining Endorsement from the National Pharmaceutical Regulatory Agency (NPRA)

  • Application form for Endorsement Letter of Ancillary Component for Registration of Combination Product (Appendix 3)
  • Ancillary Drug Dossier (Appendix 2)

Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)

Submitting the documentation to the CAB, CAB to issue a certificate and report upon satisfactory assessment.

Stage 3 – Application for Registration to MDA

After obtaining the endorsement letter from the NPRA, certificate, and report from the CAB, an application can be made on Medcast 2.0 for the MDA to evaluate the medical device application.