Home About Qualtech NEWS 6 Expected Big Changes in the Philippine Medical Device Registration: Is your Company Ready?
6 Expected Big Changes in the Philippine Medical Device Registration: Is your Company Ready?

February 18, 2019

In March 2018, the Department of Health has officially issued a new Guidance concerning the adoption of ASEAN Harmonized Technical Requirements for Medical Device Registration, and was set to be implemented in March of this year. Based from informal talks between Qualtech and PFDA, however, the reinforcement of guidelines shall take place on April 11th. Despite its implementation being hazy at the moment, those information considered to be highly valuable to most manufacturers are hereby outlined, along with some solutions on how to get through with the challenges brought about by the said change.

1.       Certificates of Exemption will be revoked soon 

Previously, the classification of medical devices in Philippines are based into two (2) main categories, namely,  registrable and non-registrable. Upon the implementation of Administrative Order 2018-0002, all medical devices shall already be regulated by the PFDA.

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*Note: The new guidelines shall only apply to all medical devices to be sold, exported, imported, exported, manufactured, and used in the Philippines. Separate guidelines shall be issued for in-vitro diagnostic and refurbished medical devices

That being said, holders of Certificates of Exemption (COE) will be greatly affected by this change. All devices initially exempted for registration shall be reclassified by PFDA as Class A, B, C or D (with the risk level of product). The good news is that:

★ The PFDA  has promised issuing a grace period for COE holders, allowing the importation of exempted devices up to such period set by the agency.

★ All non-registrable medical devices, regardless of its Risk Class, shall apply for Notification. The documentary requirements for obtaining a Certificate of Medical Device Notification (CMDN) would consist mostly of Administrative documents and are rather less technical.

Due to the high volume of nonregistrable medical devices placed on the market, the reclassification process would take some time. Hence, the requirements for obtaining Certificate of Medical Device Registration (CMDR) for nonregistrable devices to be classified as Class B, C or D shall be fully imposed in the latter phases of implementation. Initially, all nonregistrable medical devices shall apply for Notification in order to obtain a Certificate of Medical Device Notification (CMDN) which, is supposedly valid for 5 years as per AO 2018-0002.

Further, the Guidelines for Classification of Medical Devices shall be issued as a separate Guidance Document, and is currently underway.

In lieu of the current classification, PFDA will be classifying all registrable medical devices to their corresponding risk classes. Subsequently, a list of all medical devices under Class A, B, C and D will be issued prior to the implementation of the Administrative Order. If your device is currently registrable, and was reclassified as Class A, then a Notification shall be applied. But if your device is reclassified as B, C or D, then Registration shall be applied.

The following points must be kept in mind:

★ This does not apply for existing Certificates of Product Registration (CPR’s). Therefore, if you already have a Certificate of Registration on hand, then you don’t have to reapply for Registration. Once you have your CPR’s renewed, the expected validity of your certificates will be 5 years.

!FRIENDLY REMINDERS FOR EXISTING CPR HOLDERS:

◉ Make sure that your CPR’s are renewed prior to the commencement of the new regulations. If you have reached past the four-month grace period for certificate renewal, this would serve as a ground for reapplication. If your reapplication falls on the implementation of the new regulation, then you’re likely to follow the Common Submission Dossier Template (CSDT) format. On top of that, the changes of registration fees (which is expected to be higher) might already be imposed along the implementation.

 2.       Adoption of CSDT Format

The dossier template will almost follow the Singapore Health Sciences Authority (HSA) submission format. Most of the technical documents submitted, however, are still retained in the current documents. Additional requirements, including, Declaration of Conformity, Executive Summary, and Essential Principles shall be included. Clinical evidence shall be mandatory for implantable devices, new devices, devices incorporated with new raw materials, and refurbished medical devices.

As most of the current requirements for PH submission are also present under the CSDT, the difficulties for complying with future requirements shouldn’t be a problem. From the writers’ perspective, the new format should merely be a rearrangement of current requirements, with addition of executive summary and essential principles which just serves to summarize each document content.

3.       Validity of Initial Registration Certificates

Upon implementation of the new guidance, the validity of CMDN and CMDR will be 5 years, instead of just 1 year. After 5 years, automatic renewal should follow, for which an additional 5-year validity shall be issued.

While this might seem to be a good news for most, here’s the catch:

In parallel with this change comes along the increased cost of registration application, which, is still being drafted to date.

4.       New Schedule of Fees

A subsequent increase in fees shall be expected for various applications which chiefly includes registration and amendment applications, not to mention other authorization applications which might also incur charges in the future.

A: Medical Device Products

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*fees are in Philippine Peso

*Annual fees shall be collected each year upon the issuance of marketing authorization.

Noncompliance shall lead to the revocation of the marketing authorization.

B: Variations

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Apparently, PFDA is still currently in talks with stakeholders regarding the tremendous increase in application fees. While this might be a problem for some manufacturers, these changes are inevitable due to allotment of funds to operations, upgrading of facilities, human resource development, post market surveillance activities, among others.

If you wish to avoid the registration fee increases and get the approvals at the earliest possible time, you may opt to register your devices earlier before the implementation of the new regulations.

5.       Turn-around time

Although it was stated in the new regulations that the evaluation period shall take place within 180 calendar days, the length of review time, however isn’t yet considered for each risk class. It would be expected that the review time for Class A would be shorter than the proposed duration. A separate notice shall be issued by PFDA regarding the final evaluation period of each device under their respective risk classes.

Regardless, a one-time 90 day compliance shall still be followed, where a failure to reply shall be a ground for reapplication with a corresponding fee.

It is important that most documents are almost 90% complete at the time of submission in order to avoid a lot questions from the authorities, and less risk of undergoing reapplication which entails larger costs for the company.

PFDA Evaluation Turnaround Time

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*Initial Product Registration Evaluations as per current regulations, is 180 calendar days. From experience however, it can go around 270 days (or 9 months) at an average.

*Certificate of Exemptions, as per current regulations, are issued a month after evaluation provided that there are no outstanding deficiencies. Based on experience however, the issuance thereof takes around 2-3 months even without deficiencies. This might be due to administrative checking, printing, releasing procedures which are done before the issuance of certificate

6.       Still, no grouping concept for medical devices is followed

In some countries, multiple medical devices can be grouped into one submission application as either family, system, set or kit given a set of conditions that all devices grouped together have a common intended purpose. Philippine grouping system, however is unique.

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* In cases where separate certificates will be issued, the total registration fee will be: Fee multiplied by the number of certificates issued

With the upcoming increase in fees, the cost of registration might be a painstaking encounter for manufacturers intending to register device systems in Philippines. However, as mentioned in the previous paragraphs, PFDA is still currently undergoing deliberation with stakeholders with regards to the new schedule of fees. Hence, for as long as the jury is out, no one knows what the verdict will be.

Moreover, the risk classification for devices included in a system, kit or set is not mentioned in the new guidelines.

 

Conclusion

The success of a regulation lies not only upon the regulator's ability to formulate clear and feasible set of laws, rules and regulations, but also the nation's ability to comply with these laws. Certainly, PFDA’s efforts of keeping up with the standards set by the ASEAN Harmonization has become visible with the issuance of the Administrative Order 2018-0002. However, the rules for implementation is not yet set and hence, a clear-cut guidelines has to be provided prior to its implementation date, in order for manufacturers to get a clearer picture on how to comply with local requirements.

 

Reference:

Administrative Order 2018-0002

 

 

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Home About Qualtech NEWS 6 Expected Big Changes in the Philippine Medical Device Registration: Is your Company Ready?